Archive for February, 2012

ScienceDaily (Feb. 13, 2012) — Novel gene abnormalities discovered in a subpopulation of lung and colorectal tumors could potentially identify patients with a good chance of responding to highly specific "targeted" drugs already in use for treating other cancers, scientists report.

The genetic alterations -- pieces of two genes fused together -- showed up in a massive search of the DNA in stored tumor samples of non-small cell lung cancer and colorectal cancer, said researchers from Dana-Farber Cancer Institute and Foundation Medicine, Inc. These specific genetic abnormalities had not been previously linked to the two cancer types.

Their results were published online by the journal Nature Medicine. Other cancers with similar genetic alterations often respond to "targeted" drugs s that block overactive proteins called tyrosine kinase inhibitors. This suggests that the same drugs also may be effective against lung and colorectal tumors driven by the newly found gene fusions. Because these drugs are already approved to treat cancer, it should be possible to move rapidly to clinical trials in colorectal and lung cancer, the authors said.

If the trials are successful, physicians could potentially test patients' tumors for the presence of the gene fusions and prescribe a medication matched to those alterations, said Pasi A. Jänne, MD, PhD, a thoracic oncologist at Dana-Farber and co-senior author of the report along with Philip J. Stephens, PhD, and Maureen Cronin, PhD, of Foundation Medicine. Doron Lipson, PhD, is the paper's first author. "This is a textbook example of personalized medicine for lung cancer -- a genetic alteration found in a subset of patients that we can now look for and use as a means to select particular therapies," Jänne said.

"In the past, although these targeted drugs were available, they were not chosen for a particular subset, but instead given to everybody," he explained. "This will increase the likelihood of those therapies being more successful."

The researchers estimate that less than 1 percent of Caucasians and about 2 percent of Asians with lung cancers carry this alteration -- a fusion gene labeled KIF5B-RET. However, they said the finding opens a significant therapeutic opportunity.

"In a common indication like non-small cell lung cancer, identifying even a small subpopulation of individuals with gene fusions who may be responsive to a targeted therapy has the potential for major therapeutic impact," said Stephens, executive director of cancer genomics at Foundation Medicine. "This joint research with Dana-Farber translates genomic research to the clinic and we expect that it may quickly have a positive impact for patients."

The American Cancer Society projects that 226,160 Americans will be diagnosed with lung cancer in 2012 and 160,340 will die of the disease.

Foundation Medicine scientists identified the novel fusion gene in a DNA tumor sample removed from a 44-year-old man with non-small cell lung cancer (NSCLC) who had never smoked. The hybrid gene is composed of a piece of a cell growth gene, RET, and part of another gene, KIF5B. This abnormal gene combination causes RET to act like a growth switch stuck in the "on" position, spurring uncontrolled cell division.

The company formed a collaboration with Jänne and his Dana-Farber colleagues to follow up the discovery. "We looked for the RET fusion gene in a larger collection of lung tumor samples to determine how common it is, and if it is acting as an oncogene [a gene that drives cancer]" said Jänne. They searched samples from 121 Caucasian patients and 405 Asian patients who had never smoked or had rarely smoked in the past. The RET fusion gene was detected in 1 of the Caucasian samples (0.8 percent) and 9 of the Asian patient samples (2 percent).

Thyroid cancers containing RET gene hybrids are known to respond to certain targeted drugs that inhibit RET. When Dana-Farber investigators tested three such inhibitors -- sorafenib, sunitinib and vandetinib -- on cultured cells containing the newly discovered RET mutation, each of the drugs killed those cells, the scientists reported. Jänne noted that some patients with NSCLC have responded to treatment with these inhibitor drugs. The researchers want to find out whether those patients had RET mutations in their tumors.

The Foundation Medicine scientists also sequenced DNA samples from 40 patients with colorectal cancer. Along with numerous known mutations, the researchers identified a novel gene alteration, C2orf44-ALK, that causes a 90-fold overexpression of the ALK protein leading to cancerous proliferation. Overexpressed ALK is also found in a small percentage of lung cancer cases and can be inhibited by the targeted drug crizotinib. This raises the possibility of using crizotinib to target the C2orf44-ALK fusion gene in colorectal cancer, the researchers said.

In addition to Cronin, Jänne, Lipson and Stephens, the paper's co-authors were from Sharett Institute of Oncology, Jerusalem; TEVA Pharmaceutical Industries, Petach Tikva, Israel; Samsung Medical Center, Seoul, Korea; Nagoya City University Graduate School of Medical Sciences, Japan; Asan Medical Center, Seoul, Korea; and Albany Medical Center, New York.

The research was funded in part by the Dana-Farber/Harvard Cancer Center Lung Cancer SPORE grant from the National Cancer Institute and the Cammarata Family Foundation Research Fund.

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The above story is reprinted from materials provided by Dana-Farber Cancer Institute, via Newswise.

Note: Materials may be edited for content and length. For further information, please contact the source cited above.

Journal Reference:

Doron Lipson, Marzia Capelletti, Roman Yelensky, Geoff Otto, Alex Parker, Mirna Jarosz, John A Curran, Sohail Balasubramanian, Troy Bloom, Kristina W Brennan, Amy Donahue, Sean R Downing, Garrett M Frampton, Lazaro Garcia, Frank Juhn, Kathy C Mitchell, Emily White, Jared White, Zac Zwirko, Tamar Peretz, Hovav Nechushtan, Lior Soussan-Gutman, Jhingook Kim, Hidefumi Sasaki, Hyeong Ryul Kim, Seung-il Park, Dalia Ercan, Christine E Sheehan, Jeffrey S Ross, Maureen T Cronin, Pasi A Jänne, Philip J Stephens. Identification of new ALK and RET gene fusions from colorectal and lung cancer biopsies. Nature Medicine, 2012; DOI: 10.1038/nm.2673

Note: If no author is given, the source is cited instead.

Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of ScienceDaily or its staff.

Originally posted here:
Newly identified fusion genes in lung and colorectal cancer may guide treatment with 'targeted' drugs

(RTTNews.com) - Biotechnology company Seattle Genetics Inc. (SGEN) Monday reported a loss for the fourth quarter that narrowed from a year ago, due mainly to sales of Hodgkin Lymphoma drug Adcetris approved last August. Loss for the quarter was smaller when compared to analyst estimates, while revenues too came in ahead of expectations.

Looking ahead, Seattle Genetics detailed its revenue forecast for 2012. Nonetheless, investors were not too impressed with the results, sending Seattle Genetics shares down 7 percent in after hours trade on the Nasdaq.

The Bothell, Washington-based company reported fourth-quarter net loss of $27 million or $0.24 per share compared to net loss of $34.5 million or $0.34 per share last year.

On average, 14 analysts polled by Thomson Reuters expected a loss of $0.31 per share for the quarter. Analysts' estimates typically exclude special items.

Results for the 2011 quarter include an $8.7 million valuation adjustment related to holdings in auction rate securities.

The company reported revenues of $48.9 million, compared to $8.1 million in the prior year. Street analysts expected revenues of $39.12 million.

Adcetris product sales for the quarter was $33.2 million. Adcetris (brentuximab vedotin) was approved by the FDA last August for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates.

The drug has been also approved for the treatment of patients with systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen. Adcetris is the first drug approved by the FDA for Hodgkin lymphoma in more than 30 years.

CEO Clay Siegall said, "...We are also executing on a broad clinical development program of Adcetris to evaluate its potential in earlier lines of therapy for Hodgkin lymphoma and mature T-cell lymphomas, as well as in other CD30-positive malignancies."

Total expenses for the quarter rose to $67.6 million from $43 million last year, reflecting higher selling expenses related to the launch of Adcetris, and increased research expenses.

Seattle Genetics expects full year 2012 revenues from collaboration and license agreements between $55 million and $65 million.

Analysts currently expect the company to report revenues of $196.21 million for 2012.

SGEN closed Monday on the Nasdaq at $18.96, up $0.36 or 1.96%, on a volume of 1.6 million shares. In after hours, the stock lost $1.34 or 7.07%.

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Seattle Genetics Loss Narrows; But Stock Down - Update

Helped by revenue growth, Seattle Genetics, Inc. narrowed its loss in the fourth quarter. Seattle Genetics is a biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer and autoimmune disease.

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Seattle Genetics Earnings Cheat Sheet for the Fourth Quarter

Results: Loss narrowed to $27.2 million (loss of 24 cents per diluted share) from $34.5 million (loss of 34 cents per share) in the same quarter a year earlier.

Revenue: Rose more than sixfold to $48.9 million from the year earlier quarter.

Actual vs. Wall St. Expectations: Seattle Genetics, Inc. beat the mean analyst estimate of a loss of 30 cents per share. It beat the average revenue estimate of $39.1 million.

Quoting Management: “We are pleased with the successful launch of ADCETRIS and our execution in bringing this drug to patients in need,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “Our commercialization initiatives continue to focus on expanding awareness of ADCETRIS among oncologists, particularly in the community setting, and ensuring an efficient reimbursement process.”

Key Stats:

The company has now beaten estimates the last two quarters. In the third quarter, it topped expectations with a loss of -35 cents versus a mean estimate of a loss of 46 cents per share.

The company’s revenue has now risen for two straight quarters. In the third quarter, revenue increased 29.2% to $20.7 million from the year earlier quarter.

Looking Forward: Expectations for the company’s next quarter performance are higher than they were ninety days ago. The average estimate for the first quarter of the next fiscal year is now at a loss of 25 cents per share, up from a loss of 31 cents. For the fiscal year, the average estimate has moved from a loss of $1.45 a share to a loss of $1.40 over the last ninety days.

(Company fundamentals provided by Xignite Financials. Earnings estimates provided by Zacks)

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To contact the reporter on this story: Derek Hoffman at staff.writers@wallstcheatsheet.com

To contact the editor responsible for this story: Damien Hoffman at editors@wallstcheatsheet.com

Excerpt from:
Seattle Genetics Inc. Earnings: Beats Analysts’ Estimates as Loss Narrows

SEATTLE, WA--(Marketwire -02/14/12)- Atossa Genetics, Inc., a privately-held health care company focused on the prevention of breast cancer through the commercialization of diagnostic tests that can detect precursors to breast cancer, and through the research, development, and ultimate commercialization of treatments for pre-cancerous lesions, announced today that it has filed a registration statement on Form S-1 with the United States Securities and Exchange Commission (SEC) relating to a proposed initial public offering of 1,000,000 shares of its common stock. Dawson James Securities, Inc. is acting as sole book-running manager of the offering.

Proceeds from this offering will be used to expand the Company's cytology and molecular diagnostics laboratory, The National Reference Laboratory for Breast Health; fund the manufacture of MASCT System units; hire and train sales and marketing personnel for the ForeCYTE and ArgusCYTE Breast Health Tests; continue its research and development of the FullCYTE and NextCYTE Breast Health Tests; support the internal research and development of the Intraductal Treatment Research Program; and for general corporate purposes.

The offering will be made only by means of a prospectus. Once available, a preliminary prospectus may be obtained from Dawson James via telephone at 561-208-2939; email at investmentbanking@dawsonjames.com, or standard mail at 925 S. Federal Highway, Suite 600, Boca Raton, FL 33432.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

About Atossa Genetics, Inc.

Atossa Genetics, Inc. is a privately held health care company based in Seattle, Washington, that provides a comprehensive set of innovative breast health evaluation products and services that provide accurate and actionable results for personalized cancer prevention and breast health. Atossa has established the National Reference Laboratory for Breast Health, a specially equipped, CLIA-registered laboratory located in Seattle that provides comprehensive test results to guide personalized breast cancer prevention and treatment solutions.

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Atossa Genetics, Inc. Announces Filing of S-1 Registration Statement

BOTHELL, Wash.--(BUSINESS WIRE)--

Seattle Genetics, Inc. (NASDAQ:SGEN - News) today reported financial results for the fourth quarter and year ended December 31, 2011. The company also highlighted the ADCETRIS (brentuximab vedotin) product launch, recent ADCETRIS clinical data, ongoing and planned clinical development activities and upcoming milestones.

“We are pleased with the successful launch of ADCETRIS and our execution in bringing this drug to patients in need,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “Our commercialization initiatives continue to focus on expanding awareness of ADCETRIS among oncologists, particularly in the community setting, and ensuring an efficient reimbursement process. We are also executing on a broad clinical development program of ADCETRIS to evaluate its potential in earlier lines of therapy for Hodgkin lymphoma and mature T-cell lymphomas, as well as in other CD30-positive malignancies. Over the past few months, we have reported encouraging data in multiple settings that support our aggressive clinical development plans, including in front-line Hodgkin lymphoma, front-line systemic ALCL and relapsed CTCL. In addition, we and our collaborators are advancing a robust pipeline of clinical and preclinical ADC programs.”

Recent Highlights

Reported clinical data on ADCETRIS (brentuximab vedotin) in multiple settings, notably demonstrating strong progress towards the company’s goal of redefining front-line therapy for Hodgkin lymphoma and mature T-cell lymphomas. ADCETRIS has not been approved for use in any of the following settings. Data were presented from:

A phase I trial evaluating sequential and concurrent administration of ADCETRIS with multi-agent chemotherapy in front-line mature T-cell lymphomas, including systemic anaplastic large cell lymphoma (sALCL). A phase I trial evaluating concurrent administration of ADCETRIS with multi-agent chemotherapy in front-line Hodgkin lymphoma. An investigator-sponsored phase II clinical trial of ADCETRIS in patients with cutaneous T-cell lymphoma (CTCL). Case studies of two patients with peripheral T-cell lymphoma (PTCL). A case series of patients with Hodgkin lymphoma or sALCL who received greater than 16 cycles of ADCETRIS. An analysis of the outcome of patients with relapsed Hodgkin lymphoma or sALCL who received an allogeneic stem cell transplant after treatment with ADCETRIS.

Announced multiple recent clinical trial initiations to broadly evaluate ADCETRIS in CD30-positive malignancies. Highlights include:

Initiated a phase II clinical trial in relapsed or refractory CD30-positive non-Hodgkin lymphomas, including PTCL, diffuse large B-cell lymphoma and other less common lymphoma subtypes. Initiated a phase II clinical trial in patients with CD30-positive non-lymphoma malignancies, including solid tumors, leukemia and multiple myeloma. Supported five investigator-sponsored trials (ISTs), including trials to evaluate ADCETRIS in earlier lines of Hodgkin lymphoma therapy, in older people with Hodgkin lymphoma and in other CD30-positive malignancies; expect to support multiple additional ISTs utilizing ADCETRIS to begin during 2012.

Demonstrated continued progress across product pipeline of antibody-drug conjugates (ADCs), including:

Completed enrollment in a phase I trial of single-agent SGN-75 in non-Hodgkin lymphoma and renal cell carcinoma. Completed enrollment in a phase I clinical trial of ASG-5ME for patients with pancreatic cancer; patient enrollment in a phase I clinical trial of ASG-5ME for prostate cancer is ongoing. ASG-5ME is a co-development program with Agensys, an affiliate of Astellas. Continued patient enrollment in a phase I clinical trial of ASG-22ME for solid tumors. ASG-22ME is a co-development program with Agensys, an affiliate of Agensys.

Achieved multiple milestones driven by collaborator progress under ADC agreements, including:

Preclinical milestone payments from Pfizer and Abbott. Three payments from Agensys, an affiliate of Astellas, upon exercise of options for additional exclusive antigen licenses under the companies’ ongoing ADC collaboration.

Upcoming Milestones

Planning multiple milestones for ADCETRIS and other pipeline programs, including:

Initiating a phase III clinical trial of ADCETRIS in CTCL by mid-2012. Initiating a phase III clinical trial of ADCETRIS in front-line advanced stage Hodgkin lymphoma by late 2012 to early 2013. Initiating a phase III clinical trial of ADCETRIS in front-line mature T-cell lymphomas, including sALCL, by late 2012 to early 2013. Submitting an application during the first half of 2012 to Health Canada for approval of ADCETRIS in relapsed Hodgkin lymphoma and sALCL. Millennium/Takeda expects a decision during 2012 from the European Medicines Agency (EMA) on an ADCETRIS marketing authorization application (MAA) filed by Takeda Global Research & Development Centre (Europe); the MAA filing was accepted by the EMA in June 2011. Initiating during 2012 a phase Ib clinical trial to evaluate SGN-75 in combination with everolimus, an mTOR inhibitor, for renal cell carcinoma. Submitting an investigational new drug application during 2012 for SGN-CD19A, a CD19-targeted ADC.

Fourth Quarter and Year 2011 Financial Results

Revenues in the fourth quarter of 2011 were $48.9 million, compared to $8.1 million in the fourth quarter of 2010. Fourth quarter 2011 revenues include ADCETRIS net product sales of $33.2 million. For the year 2011, revenues were $94.8 million, compared to $107.5 million for the year 2010. Revenues for the year in 2011 include $43.2 million in ADCETRIS net product sales. In addition, 2011 revenues were driven by revenue under the company’s ADCETRIS and ADC collaborations. Revenues for the year ended December 31, 2010 included approximately $70 million earned in the first half of 2010 under the dacetuzumab collaboration with Genentech that ended in June 2010.

Total costs and expenses for the fourth quarter of 2011 were $67.6 million, compared to $43.0 million for the fourth quarter of 2010. For the year 2011, total costs and expenses were $239.2 million, compared to $175.7 million for the year 2010. The planned increases in 2011 costs and expenses were primarily driven by sales and marketing activities related to the launch of ADCETRIS and higher research and development expenses, including clinical development to evaluate potential additional applications of ADCETRIS and to advance the company’s ADC pipeline programs. Under the ADCETRIS collaboration with Millennium, development costs incurred by Seattle Genetics are included in research and development expense. Joint development costs are co-funded by Millennium on a 50:50 basis. Reimbursement payments received from Millennium are recognized as revenue over the development period of the collaboration along with other development payments received, including the upfront payment and milestone payments. Non-cash, share-based compensation expense for the year 2011 was $20.0 million, compared to $14.3 million for the year 2010.

Net loss for the fourth quarter of 2011 was $27.2 million, or $0.24 per share, compared to a net loss of $34.5 million, or $0.34 per share, for the fourth quarter of 2010. Net loss in the fourth quarter of 2011 includes an $8.7 million valuation adjustment for the company’s holdings in auction rate securities, resulting in a carrying value of $5.8 million. For the year ended December 31, 2011, net loss was $152.0 million, or $1.34 per share, compared to net loss of $66.3 million, or $0.66 per share, for year ended December 31, 2010.

As of December 31, 2011, Seattle Genetics had $330.7 million in cash and investments, compared to $294.8 million as of December 31, 2010. The increase in cash and investments reflects net proceeds of approximately $168 million from the company’s public offering of common stock in February 2011 and collaboration payments received during 2011 totaling approximately $70 million.

2012 Financial Outlook

Seattle Genetics anticipates that revenues from collaboration and license agreements in 2012 will be in the range of $55 million to $65 million. These revenues will be generated from fees, milestones and reimbursements earned through the company’s ADCETRIS and ADC collaborations. The company is not providing guidance on expected revenue from ADCETRIS product sales at this time.

Total research and development and selling, general and administrative expenses in 2012 are expected to be in the range of $245 million to $270 million, approximately 35 percent of which is expected to be attributable to selling, general and administrative expenses. Operating expenses will be directed primarily towards commercialization and clinical trials of ADCETRIS, development and clinical activities for SGN-75, ASG-5ME and ASG-22ME, IND-enabling activities for SGN-CD19A, and advancing other preclinical programs. Non-cash expenses are expected to be in the range of $30 million to $33 million in 2012, primarily attributable to share-based compensation expense.

Conference Call Details

Seattle Genetics’ management will host a conference call and webcast to discuss the financial results and provide an update on business activities. The event will be held today at 1:30 p.m. Pacific Time (PT); 4:30 p.m. Eastern Time (ET). The live event will be available from Seattle Genetics’ website at http://www.seattlegenetics.com, under the Investors and News section, or by calling (877) 941-8609 (domestic) or (480) 629-9692 (international). The access code is 4509854. A replay of the discussion will be available beginning at approximately 3:30 p.m. PT today from Seattle Genetics’ website or by calling (800) 406-7325 (domestic) or (303) 590-3030 (international), using access code 4509854. The telephone replay will be available until 4:00 p.m. PT on Wednesday, February 15, 2012.

About ADCETRIS

ADCETRIS (brentuximab vedotin) is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells. ADCETRIS is approved for the treatment of patients with relapsed Hodgkin lymphoma and for the treatment of patients with relapsed sALCL.

About Seattle Genetics

Seattle Genetics is a biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer. The FDA granted accelerated approval of ADCETRIS in August 2011 for two indications. ADCETRIS is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has three other clinical-stage ADC programs: SGN-75, ASG-5ME and ASG-22ME. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Abbott, Bayer, Celldex Therapeutics, Daiichi Sankyo, Genentech, GlaxoSmithKline, Millennium, Pfizer and Progenics, as well as ADC co-development agreements with Agensys, an affiliate of Astellas, and Genmab. More information can be found at http://www.seattlegenetics.com.

Certain of the statements made in this press release are forward looking, such as those, among others, relating to the company’s expectations for initiation of future clinical trials, data availability from ongoing clinical trials, expectations for additional regulatory approvals and expectations for 2012 collaboration and license revenue. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks that the safety and/or efficacy results of our clinical trials of ADCETRIS affect the commercial potential or ability to initiate future clinical trials of ADCETRIS. We may also be delayed in our planned trial initiations and regulatory submissions and approvals for reasons outside of our control. We may also fail to receive milestone payments under our collaborations and experience unforeseen increased expenses or unexpected reductions in revenues. More information about the risks and uncertainties faced by Seattle Genetics is contained in the company’s 10-Q for the quarter ended September 30, 2011 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

  Seattle Genetics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands)     December 31,
2011   December 31,
2010 Assets Cash, cash equivalents, short and long term investments $ 330,696 $ 294,840 Other assets   94,520   35,096 Total assets $ 425,216 $ 329,936   Liabilities and Stockholders' Equity Accounts payable and accrued liabilities $ 53,048 $ 25,783 Deferred revenue and long-term liabilities 153,319 142,635 Stockholders' equity   218,849   161,518 Total liabilities and stockholders' equity $ 425,216 $ 329,936     Seattle Genetics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except per share amounts)    

Three months ended
December 31,

  Twelve months ended
December 31,   2011       2010     2011       2010   Revenues Net product sales $ 33,194 $ - $ 43,241 $ - Collaboration and license agreement revenues   15,693     8,146     51,537     107,470   Total revenues   48,887     8,146     94,778     107,470   Costs and expenses Cost of sales 2,391 - 3,115 - Research and development 40,239 32,520 163,396 146,410 Selling, general and administrative   24,954     10,522     72,659     29,258   Total costs and expenses   67,584     43,042     239,170     175,668   Loss from operations (18,697 ) (34,896 ) (144,392 ) (68,198 ) Investment income (loss), net   (8,468 )   350     (7,638 )   1,933   Net loss $ (27,165 ) $ (34,546 ) $ (152,030 ) $ (66,265 )   Basic and diluted net loss per share $ (0.24 ) $ (0.34 ) $ (1.34 ) $ (0.66 )  

Weighted-average shares used in computing basic and diluted net loss per share

  115,064     101,450     113,098     101,055    

Original post:
Seattle Genetics Reports Fourth Quarter and Year 2011 Financial Results

Background

Cardiosphere-derived cells (CDCs) reduce scarring after myocardial infarction, increase viable myocardium, and boost cardiac function in preclinical models. We aimed to assess safety of such an approach in patients with left ventricular dysfunction after myocardial infarction.

Methods In the prospective, randomised CArdiosphere-Derived aUtologous stem CElls to reverse ventricUlar dySfunction (CADUCEUS) trial, we enrolled patients 2—4 weeks after myocardial infarction (with left ventricular ejection fraction of 25—45%) at two medical centres in the USA. An independent data coordinating centre randomly allocated patients in a 2:1 ratio to receive CDCs or standard care. For patients assigned to receive CDCs, autologous cells grown from endomyocardial biopsy specimens were infused into the infarct-related artery 1·5—3 months after myocardial infarction. The primary endpoint was proportion of patients at 6 months who died due to ventricular tachycardia, ventricular fibrillation, or sudden unexpected death, or had myocardial infarction after cell infusion, new cardiac tumour formation on MRI, or a major adverse cardiac event (MACE; composite of death and hospital admission for heart failure or non-fatal recurrent myocardial infarction). We also assessed preliminary efficacy endpoints on MRI by 6 months. Data analysers were masked to group assignment. This study is registered with ClinicalTrials.gov, NCT00893360. Findings

Between May 5, 2009, and Dec 16, 2010, we randomly allocated 31 eligible participants of whom 25 were included in a per-protocol analysis (17 to CDC group and eight to standard of care). Mean baseline left ventricular ejection fraction (LVEF) was 39% (SD 12) and scar occupied 24% (10) of left ventricular mass. Biopsy samples yielded prescribed cell doses within 36 days (SD 6). No complications were reported within 24 h of CDC infusion. By 6 months, no patients had died, developed cardiac tumours, or MACE in either group. Four patients (24%) in the CDC group had serious adverse events compared with one control (13%; p=1·00). Compared with controls at 6 months, MRI analysis of patients treated with CDCs showed reductions in scar mass (p=0·001), increases in viable heart mass (p=0·01) and regional contractility (p=0·02), and regional systolic wall thickening (p=0·015). However, changes in end-diastolic volume, end-systolic volume, and LVEF did not differ between groups by 6 months.

Interpretation

We show intracoronary infusion of autologous CDCs after myocardial infarction is safe, warranting the expansion of such therapy to phase 2 study. The unprecedented increases we noted in viable myocardium, which are consistent with therapeutic regeneration, merit further assessment of clinical outcomes.

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Intracoronary cardiosphere-derived cells for heart regeneration after myocardial infarction (CADUCEUS): a prospective ...

Public release date: 13-Feb-2012
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Contact: Sally Stewart
sally.stewart@cshs.org
310-248-6566
Cedars-Sinai Medical Center

Results from a Cedars-Sinai Heart Institute clinical trial show that treating heart attack patients with an infusion of their own heart-derived cells helps damaged hearts re-grow healthy muscle.

Patients who underwent the stem cell procedure demonstrated a significant reduction in the size of the scar left on the heart muscle by a heart attack. Patients also experienced a sizable increase in healthy heart muscle following the experimental stem cell treatments.

One year after receiving the stem cell treatment, scar size was reduced from 24 percent to 12 percent of the heart in patients treated with cells (an average drop of about 50 percent). Patients in the control group, who did not receive stem cells, did not experience a reduction in their heart attack scars.

The study appears online at http://www.thelancet.com and will be in a future issue of the journal's print edition.

"While the primary goal of our study was to verify safety, we also looked for evidence that the treatment might dissolve scar and regrow lost heart muscle," said Eduardo Marb?n, MD, PhD, the director of the Cedars-Sinai Heart Institute who invented the procedures and technology involved in the study. "This has never been accomplished before, despite a decade of cell therapy trials for patients with heart attacks. Now we have done it. The effects are substantial, and surprisingly larger in humans than they were in animal tests."

"These results signal an approaching paradigm shift in the care of heart attack patients," said Shlomo Melmed, MD, dean of the Cedars-Sinai medical faculty and the Helene A. and Philip E. Hixon Chair in Investigative Medicine. "In the past, all we could do was to try to minimize heart damage by promptly opening up an occluded artery. Now, this study shows there is a regenerative therapy that may actually reverse the damage caused by a heart attack."

The clinical trial, named CADUCEUS (CArdiosphere-Derived aUtologous stem CElls to Reverse ventricUlar dySfunction), was part of a Phase I investigative study approved by the U.S. Food and Drug Administration and supported by the National Heart, Lung, and Blood Institute.

As an initial part of the study, in 2009, Marb?n and his team completed the world's first procedure in which a patient's own heart tissue was used to grow specialized heart stem cells. The specialized cells were then injected back into the patient's heart in an effort to repair and re-grow healthy muscle in a heart that had been injured by a heart attack.

The 25 patients -- average age of 53 -- who participated in this completed study experienced heart attacks that left them with damaged heart muscle. Each patient underwent extensive imaging scans so doctors could pinpoint the exact location and severity of the scars wrought by the heart attack. Patients were treated at Cedars-Sinai Heart Institute and at Johns Hopkins Hospital in Baltimore.

Eight patients served as controls in the study, receiving conventional medical care for heart attack survivors, including prescription medicine, exercise recommendations and dietary advice.

The other 17 patients who were randomized to receive the stem cells underwent a minimally invasive biopsy, under local anesthesia. Using a catheter inserted through a vein in the patient's neck, doctors removed small pieces of heart tissue, about half the size of a raisin. The biopsied heart tissue was then taken to Marb?n's specialized lab at Cedars-Sinai, using methods he invented to culture and multiply the cells.

In the third and final step, the now-multiplied heart-derived cells ? approximately 12 million to 25 million ? were reintroduced into the patient's coronary arteries during a second, minimally invasive [catheter] procedure.

Patients who received stem cell treatment experienced an average of 50 percent reduction in their heart attack scars 12 months after infusion while patients who received standard medical management did not experience shrinkage in the damaged tissue.

"This discovery challenges the conventional wisdom that, once established, scar is permanent and that, once lost, healthy heart muscle cannot be restored," said Marb?n, The Mark S. Siegel Family Professor.

The process to grow cardiac-derived stem cells involved in the study was developed earlier by Marb?n when he was on the faculty of Johns Hopkins University. The university has filed for a patent on that intellectual property and has licensed it to a company in which Dr. Marb?n has a financial interest. No funds from that company were used to support the clinical study. All funding was derived from the National Institutes of Health and Cedars-Sinai Medical Center.

###

About the Cedars-Sinai Heart Institute

The Cedars-Sinai Heart Institute is internationally recognized for outstanding heart care built on decades of innovation and leading-edge research. From cardiac imaging and advanced diagnostics to surgical repair of complex heart problems to the training of the heart specialists of tomorrow and research that is deepening medical knowledge and practice, the Cedars-Sinai Heart Institute is known around the world for excellence and innovations.

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First-of-its-kind stem cell study re-grows healthy heart muscle in heart attack patients

February 13, 2012

Researchers at the University of Cambridge report that they created cerebral cortex cells from a small sample of human skin.

The new development could pave the way for techniques to explore a wide range of diseases such as autism and Alzheimer’s.

The findings could also enable scientists to study how the human cerebral cortex develops — and how it “wires up” and how that can go wrong.

“This approach gives us the ability to study human brain development and disease in ways that were unimaginable even five years ago,” Dr Rick Livesey of the Gurdon Institute and Department of Biochemistry at the University of Cambridge said in a statement.

During the research, the scientists biopsied skin from patients and then reprogrammed the cells from the skin samples back into stem cells.

These stem cells, along with human embryonic stem cells, were used to generate cerebral cortex cells.

Livesey said they are using this system to help recreate Alzheimer’s disease in the lab, which primarily affects the type of nerve cell the researchers made.

“Dementia is the greatest medical challenge of our time – we urgently need to understand more about the condition and how to stop it,” Dr Simon Ridley, Head of Research at Alzheimer’s Research UK, said in a press release. “We hope these findings can move us closer towards this goal.”

Brain cells developed this way could help researchers gain a better understanding of how the brain develops and what goes wrong when it is affected by disease.

Scientists hope the cells could be used to provide healthy tissues, which can be implanted into patients to treat neurodegenerative diseases and brain damage.

The findings were published in the journal Nature Neuroscience.

—

On the Net:

Source: RedOrbit Staff & Wire Reports

Original post:
Researchers Develop Cerebral Cortex Cells From Skin

Newswise — Breast cancer stem cells are thought to be the sole source of tumor recurrence and are known to be resistant to radiation therapy and don’t respond well to chemotherapy.

Now, researchers with the UCLA Department of Radiation Oncology at UCLA’s Jonsson Comprehensive Cancer Center report for the first time that radiation treatment –despite killing half of all tumor cells during every treatment - transforms other cancer cells into treatment-resistant breast cancer stem cells.

The generation of these breast cancer stem cells counteracts the otherwise highly efficient radiation treatment. If scientists can uncover the mechanisms and prevent this transformation from occurring, radiation treatment for breast cancer could become even more effective, said study senior author Dr. Frank Pajonk, an associate professor of radiation oncology and Jonsson Cancer Center researcher.

“We found that these induced breast cancer stem cells (iBCSC) were generated by radiation-induced activation of the same cellular pathways used to reprogram normal cells into induced pluripotent stem cells (iPS) in regenerative medicine,” said Pajonk, who also is a scientist with the Eli and Edythe Broad Center of Regenerative Medicine at UCLA. “It was remarkable that these breast cancers used the same reprogramming pathways to fight back against the radiation treatment.”

The study appears DATE in the early online edition of the peer-reviewed journal Stem Cells.

“Controlling the radiation resistance of breast cancer stem cells and the generation of new iBCSC during radiation treatment may ultimately improve curability and may allow for de-escalation of the total radiation doses currently given to breast cancer patients, thereby reducing acute and long-term adverse effects,” the study states.

There are very few breast cancer stem cells in a larger pool of breast cancer cells. In this study, Pajonk and his team eliminated the smaller pool of breast cancer stem cells and then irradiated the remaining breast cancer cells and placed them into mice.

Using a unique imaging system Pajonk and his team developed to visualize cancer stem cells, the researchers were able to observe their initial generation into iBCSC in response to the radiation treatment. The newly generated iBCSC were remarkably similar to breast cancer stem cells found in tumors that had not been irradiated, Pajonk said.

The team also found that the iBCSC had a more than 30-fold increased ability to form tumors compared to the non-irradiated breast cancer cells from which they originated.

Pajonk said that the study unites the competing models of clonal evolution and the hierarchical organization of breast cancers, as it suggests that undisturbed, growing tumors maintain a small number of cancer stem cells. However, if challenged by various stressors that threaten their numbers, including ionizing radiation, the breast cancer cells generate iBCSC that may, together with the surviving cancer stem cells, repopulate the tumor.

“What is really exciting about this study is that it gives us a much more complex understanding of the interaction of radiation with cancer cells that goes far beyond DNA damage and cell killing,” Pajonk said. “The study may carry enormous potential to make radiation even better.”

Pajonk stressed that breast cancer patients should not be alarmed by the study findings and should continue to undergo radiation if recommended by their oncologists.

“Radiation is an extremely powerful tool in the fight against breast cancer,” he said. “If we can uncover the mechanism driving this transformation, we may be able to stop it and make the therapy even more powerful.”

This study was funded by the National Cancer Institute, the California Breast Cancer Research Program and the Department of Defense.

UCLA's Jonsson Comprehensive Cancer Center has more than 240 researchers and clinicians engaged in disease research, prevention, detection, control, treatment and education. One of the nation's largest comprehensive cancer centers, the Jonsson center is dedicated to promoting research and translating basic science into leading-edge clinical studies. In July 2011, the Jonsson Cancer Center was named among the top 10 cancer centers nationwide by U.S. News & World Report, a ranking it has held for 11 of the last 12 years. For more information on the Jonsson Cancer Center, visit our website at http://www.cancer.ucla.edu.

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Radiation Treatment Generates Cancer Stem Cells from Less Aggressive Breast Cancer Cells

ScienceDaily (Feb. 13, 2012) — Breast cancer stem cells are thought to be the sole source of tumor recurrence and are known to be resistant to radiation therapy and don't respond well to chemotherapy.

Now, researchers with the UCLA Department of Radiation Oncology at UCLA's Jonsson Comprehensive Cancer Center report for the first time that radiation treatment -- despite killing half of all tumor cells during every treatment -- transforms other cancer cells into treatment-resistant breast cancer stem cells.

The generation of these breast cancer stem cells counteracts the otherwise highly efficient radiation treatment. If scientists can uncover the mechanisms and prevent this transformation from occurring, radiation treatment for breast cancer could become even more effective, said study senior author Dr. Frank Pajonk, an associate professor of radiation oncology and Jonsson Cancer Center researcher.

"We found that these induced breast cancer stem cells (iBCSC) were generated by radiation-induced activation of the same cellular pathways used to reprogram normal cells into induced pluripotent stem cells (iPS) in regenerative medicine," said Pajonk, who also is a scientist with the Eli and Edythe Broad Center of Regenerative Medicine at UCLA. "It was remarkable that these breast cancers used the same reprogramming pathways to fight back against the radiation treatment."

The study recently appeared in the early online edition of the peer-reviewed journal Stem Cells.

"Controlling the radiation resistance of breast cancer stem cells and the generation of new iBCSC during radiation treatment may ultimately improve curability and may allow for de-escalation of the total radiation doses currently given to breast cancer patients, thereby reducing acute and long-term adverse effects," the study states.

There are very few breast cancer stem cells in a larger pool of breast cancer cells. In this study, Pajonk and his team eliminated the smaller pool of breast cancer stem cells and then irradiated the remaining breast cancer cells and placed them into mice.

Using a unique imaging system Pajonk and his team developed to visualize cancer stem cells, the researchers were able to observe their initial generation into iBCSC in response to the radiation treatment. The newly generated iBCSC were remarkably similar to breast cancer stem cells found in tumors that had not been irradiated, Pajonk said.

The team also found that the iBCSC had a more than 30-fold increased ability to form tumors compared to the non-irradiated breast cancer cells from which they originated.

Pajonk said that the study unites the competing models of clonal evolution and the hierarchical organization of breast cancers, as it suggests that undisturbed, growing tumors maintain a small number of cancer stem cells. However, if challenged by various stressors that threaten their numbers, including ionizing radiation, the breast cancer cells generate iBCSC that may, together with the surviving cancer stem cells, repopulate the tumor.

"What is really exciting about this study is that it gives us a much more complex understanding of the interaction of radiation with cancer cells that goes far beyond DNA damage and cell killing," Pajonk said. "The study may carry enormous potential to make radiation even better."

Pajonk stressed that breast cancer patients should not be alarmed by the study findings and should continue to undergo radiation if recommended by their oncologists.

"Radiation is an extremely powerful tool in the fight against breast cancer," he said. "If we can uncover the mechanism driving this transformation, we may be able to stop it and make the therapy even more powerful."

This study was funded by the National Cancer Institute, the California Breast Cancer Research Program and the Department of Defense.

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The above story is reprinted from materials provided by University of California, Los Angeles (UCLA), Health Sciences, via Newswise.

Note: Materials may be edited for content and length. For further information, please contact the source cited above.

Journal Reference:

Chann Lagadec, Erina Vlashi, Lorenza Della Donna, Carmen Dekmezian and Frank Pajonk. Radiation-induced Reprograming of Breast Cancer Cells. Stem Cells, 10 FEB 2012 DOI: 10.1002/stem.1058

Note: If no author is given, the source is cited instead.

Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of ScienceDaily or its staff.

See the article here:
Radiation treatment generates cancer stem cells from less aggressive breast cancer cells, study suggests

Now, researchers with the UCLA Department of Radiation Oncology at UCLA's Jonsson Comprehensive Cancer Center report for the first time that radiation treatment –despite killing half of all tumor cells during every treatment - transforms other cancer cells into treatment-resistant breast cancer stem cells.

The generation of these breast cancer stem cells counteracts the otherwise highly efficient radiation treatment. If scientists can uncover the mechanisms and prevent this transformation from occurring, radiation treatment for breast cancer could become even more effective, said study senior author Dr. Frank Pajonk, an associate professor of radiation oncology and Jonsson Cancer Center researcher.

"We found that these induced breast cancer stem cells (iBCSC) were generated by radiation-induced activation of the same cellular pathways used to reprogram normal cells into induced pluripotent stem cells (iPS) in regenerative medicine," said Pajonk, who also is a scientist with the Eli and Edythe Broad Center of Regenerative Medicine at UCLA. "It was remarkable that these breast cancers used the same reprogramming pathways to fight back against the radiation treatment."

The study appears DATE in the early online edition of the peer-reviewed journal Stem Cells.

"Controlling the radiation resistance of breast cancer stem cells and the generation of new iBCSC during radiation treatment may ultimately improve curability and may allow for de-escalation of the total radiation doses currently given to breast cancer patients, thereby reducing acute and long-term adverse effects," the study states.

There are very few breast cancer stem cells in a larger pool of breast cancer cells. In this study, Pajonk and his team eliminated the smaller pool of breast cancer stem cells and then irradiated the remaining breast cancer cells and placed them into mice.

Using a unique imaging system Pajonk and his team developed to visualize cancer stem cells, the researchers were able to observe their initial generation into iBCSC in response to the radiation treatment. The newly generated iBCSC were remarkably similar to breast cancer stem cells found in tumors that had not been irradiated, Pajonk said.

The team also found that the iBCSC had a more than 30-fold increased ability to form tumors compared to the non-irradiated breast cancer cells from which they originated.

Pajonk said that the study unites the competing models of clonal evolution and the hierarchical organization of breast cancers, as it suggests that undisturbed, growing tumors maintain a small number of cancer stem cells. However, if challenged by various stressors that threaten their numbers, including ionizing radiation, the breast cancer cells generate iBCSC that may, together with the surviving cancer stem cells, repopulate the tumor.

"What is really exciting about this study is that it gives us a much more complex understanding of the interaction of radiation with cancer cells that goes far beyond DNA damage and cell killing," Pajonk said. "The study may carry enormous potential to make radiation even better."

Pajonk stressed that breast cancer patients should not be alarmed by the study findings and should continue to undergo radiation if recommended by their oncologists.

"Radiation is an extremely powerful tool in the fight against breast cancer," he said. "If we can uncover the mechanism driving this transformation, we may be able to stop it and make the therapy even more powerful."

Provided by University of California - Los Angeles

Read more from the original source:
Radiation treatment transforms breast cancer cells into cancer stem cells

The Everist CardioDefender device.

ANN ARBOR — Everist Genomics, a rapidly growing personalized medicine company, today announced that world-renowned scientist and genome sequencing pioneer J. Craig Venter will be the keynote speaker for its March 26th Gala Dinner at the Field Museum in Chicago.

Venter achieved global prominence in 2001 for being the first to sequence the human genome, accomplishing this feat two years in advance of the government-sponsored Human Genome Project and at a fraction of the cost. He received acclaim again in 2010 for leading a team of scientists to create the first synthetic life form, a single-cell bacterium known as Mycoplasma laboratorium. His contributions to the field of genomics — including the decoding of his own genome — have enabled the new era of personalized medicine, in which treatment of medical conditions are tailored to individual patients.

Venter, who was twice named to Time magazine’s list of the world’s 100 most influential people, founded the J. Craig Venter Institute, a research organization with more than 500 scientists and staff dedicated to human, microbial, plant, synthetic and environmental genomic research and the exploration of social and ethical issues in genomics. Venter is also founder of Synthetic Genomics Inc., a privately held company dedicated to commercializing genomic-driven solutions to address global needs such as new sources of energy, new food and nutritional products, and next generation vaccines. He was awarded the National Medal of Science in 2009, the highest honor awarded to scientists by the United States government.

In his speech, “A Celebration of the Science and Creativity Driving the New Era of Personalized Medicine,” Venter will discuss how breakthroughs in basic science research, such as genome sequencing, are paving the way for a new medical paradigm. This goal will become more attainable as the cost of genome sequencing continues to drop and advances in computational science provide stronger insights about the underlying connections between genes and human physiology.

“Personalized medicine is evolving at a rapid pace, maturing from what was once a vague concept debated in research labs to the defining characteristic of 21st Century healthcare,” said Thomas Everist, chairman of the board of directors of Everist Genomics. “The goal of our Gala is to provide the healthcare community with an opportunity to celebrate the advancements made over the last decade.   We are certain that Dr. Venter’s transcendent expertise in genomics, along with his adeptness as a speaker, will stimulate a thoughtful dialogue about the role that personalized medicine will play in improving care.”

Everist Genomics offers diagnostics, prognostics and therapeutic selection technologies. The company launched its first product last year with the introduction of OncoDefender-CRC, a prognostic test for predicting the risk of disease recurrence for early stage colorectal cancer patients. The company expanded its pipeline with the creation of a new franchise of diagnostic and prognostic tests aimed at melding personalized medicine with mobile health platforms. Everist Genomics mobile health diagnostics include CardioDefender, the world’s first hospital quality smartphone ECG system,  and AngioDefender, the first tablet computer to assist physicians in diagnosing atherosclerosis and cardiovascular disease in asymptomatic patients.

More at http://www.everistgenomics.com.

Read more from the original source:
Everist Genomics Celebrates Origins, Future of Personalized Medicine

More Topics: Choose a Sector Accounting Firms Advertising/Media/Communications Capital CEO/Board General Business Health/Biotech Internet/Technology Investment Firms Law Firms Mergers & Acquisitions Money Managers People Private Companies Public Companies Venture Capital

Posted February 13, 2012

Jill Schiaparelli

ALACHUA, Fla. ---(BUSINESS WIRE)-- AxoGen, Inc. (OTCBB: AXGN), an emerging regenerative medicine company focused on the commercialization of proprietary products and technologies for peripheral nerve reconstruction and regeneration, today announced Jill Schiaparelli will be joining as its Senior Vice President of Business Strategy and Marketing.

"Strong sales growth is key to our continued success," states Karen Zaderej, Chief Executive Officer of AxoGen, Inc. "Jill's extensive strategic marketing and leadership experience in the healthcare space will add significant value to the team and will be ideal as we execute our growth initiatives."

Prior to joining the team, Ms. Schiaparelli was a principal of JS Strategic Partners, a consultancy she founded to provide business strategy, growth initiatives, and commercialization implementation to healthcare companies and service providers. Jill also served as Global Vice President of Commercial Strategy & Business Development for ApaTech - a world leader in orthobiologics acquired by Baxter Healthcare. Earlier in her career, she held several senior positions in strategic marketing, sales operations, and analytics for the Johnson & Johnson family of companies and spent nearly a decade in investment banking.

Ms. Schiaparelli received her MBA from the Stern School of Business at New York University and a Bachelor's of Science in Business Administration from Boston University.

About AxoGen, Inc.

AxoGen (OTCBB: AXGN) is a regenerative medicine company with a portfolio of proprietary products and technologies for peripheral nerve reconstruction and regeneration. Every day people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body and their damage can result in the loss of function and feeling. In order to improve surgical reconstruction and regeneration of peripheral nerves, AxoGen has developed and licensed patented and patent-pending technologies, which are used in its portfolio of products. This portfolio includes Avance® Nerve Graft, which AxoGen believes is the first and only commercially available allograft nerve for bridging nerve discontinuities (a gap created when the nerve is severed). AxoGen's portfolio also includes AxoGuard®Nerve Connector, a coaptation aid allowing for close approximation of severed nerves, and AxoGuard® Nerve Protector that protects nerves during the body's healing process after surgery. AxoGen is bringing the science of nerve repair to life with thousands of surgical implants of AxoGen products performed in hospitals and surgery centers across the United States, including military hospitals serving U.S. service men and women.

AxoGen (formerly known as LecTec Corporation) is the parent of its wholly owned operating subsidiary, AxoGen Corporation. AxoGen's principal executive office and operations are located in Alachua, FL.

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AxoGen Appoints Jill Schiaparelli Senior Vice President of Business Strategy & Marketing

February 13, 2012, 9:47 PM EST

By Ryan Flinn

Feb. 14 (Bloomberg) -- Stem cells grown from patients’ own cardiac tissue can heal damage once thought to be permanent after a heart attack, according to a study that suggests the experimental approach may one day help stave off heart failure.

In a trial of 25 heart-attack patients, 17 who got the stem cell treatment showed a 50 percent reduction in cardiac scar tissue compared with no improvement for the eight who received standard care. The results, from the first of three sets of clinical trials generally needed for regulatory approval, were published today in the medical journal Lancet.

“The findings in this paper are encouraging,” Deepak Srivastava, director of the San Francisco-based Gladstone Institute of Cardiovascular Disease, said in an interview. “There’s a dire need for new therapies for people with heart failure, it’s still the No. 1 cause of death in men and women.”

The study, by researchers from Cedars-Sinai Heart Institute in Los Angeles and Johns Hopkins University in Baltimore, tested the approach in patients who recently suffered a heart attack, with the goal that repairing the damage might help stave off failure. While patients getting the stem cells showed no more improvement in heart function than those who didn’t get the experimental therapy, the theory is that new tissue regenerated by the stem cells can strengthen the heart, said Eduardo Marban, the study’s lead author.

“What our trial was designed to do is to reverse the injury once it’s happened,” said Marban, director of Cedars- Sinai Heart Institute. “The quantitative outcome that we had in this paper is to shift patients from a high-risk group to a low- risk group.”

Minimally Invasive

The stem cells were implanted within five weeks after patients suffering heart attacks. Doctors removed heart tissue, about the size of half a raisin, using a minimally invasive procedure that involved a thin needle threaded through the veins. After cultivating the stem cells from the tissue, doctors reinserted them using a second minimally invasive procedure. Patients got 12.5 million cells to 25 million cells.

A year after the procedure, six patients in the stem cell group had serious side effects, including a heart attack, chest pain, a coronary bypass, implantation of a defibrillator, and two other events unrelated to the heart. One of patient’s side effects were possibly linked to the treatment, the study found.

While the main goal of the trial was to examine the safety of the procedure, the decrease in scar tissue in those treated merits a larger study that focuses on broader clinical outcomes, researchers said in the paper.

Heart Regeneration

“If we can regenerate the whole heart, then the patient would be completely normal,” Marban said. “We haven’t fulfilled that yet, but we’ve gotten rid of half of the injury, and that’s a good start.”

While the study resulted in patients having an increase in muscle mass and a shrinkage of scar size, the amount of blood flowing out of the heart, or the ejection fraction, wasn’t different between the control group and stem-cell therapy group. The measurement is important because poor blood flow deprives the body of oxygen and nutrients it needs to function properly, Srivastava said.

“The patients don’t have a functional benefit in this study,” said Srivastava, who wasn’t not involved in the trial.

The technology is being developed by closely held Capricor Inc., which will further test it in 200 patients for the second of three trials typically required for regulatory approval. Marban is a founder of the Los Angeles-based company and chairman of its scientific advisory board. His wife, Lisa Marban, is also a founder and chief executive officer.

--Editors: Angela Zimm, Andrew Pollack

-0- Feb/13/2012 22:32 GMT

To contact the reporter on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

See the original post here:
Scarred Hearts Can Be Mended With Stem Cell Therapy, Study Shows

13-02-2012 12:31 Sridhar Ramaswamy, MD, Tucker Gosnell Investigator and Associate Professor of Medicine, Massachusetts General Hospital Cancer Center, Harvard Medical School, Broad Institute of Harvard and MIT, and Harvard Stem Cell Institute, discusses ongoing research into drug tolerance and resistance, specifically the roll of dormant cancer cells. If a tumor goes into remission as a result of a cancer drug and then recurs it is likely that the tumor will still respond to the initial treatment. In the dormant state the cells are resistance, in the original they are sensitive. The exact mechanism behind this has yet to be discovered. In some cases giving a course, stopping, and then continuing later on can create an additive effect, an idea that Ramaswamy calls a drug holiday. A comparison is underway between drug and non-drug induced dormant cells in order to find the mechanism that causes resistance. The ultimate goal of the research is to be able to predict and stop drug resistance.

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Dr. Ramaswamy on Dormant Tumor Cells and Resistance - Video

JERUSALEM--(BUSINESS WIRE)--

Gamida Cell announced today that the Gamida Cell-Teva Joint Venture (JV), equally held by Gamida Cell and Teva Pharmaceutical Industries, has enrolled the last of 100 patients in the international, multi-center, pivotal registration, Phase III clinical trial of StemEx, a cell therapy product in development as an alternative therapeutic treatment for adolescents and adults, with blood cancers such as leukemia and lymphoma, who cannot find a family related, matched bone marrow donor.

StemEx is a graft of an expanded population of stem/progenitor cells, derived from part of a single unit of umbilical cord blood and transplanted by IV administration along with the remaining, non-manipulated cells from the same unit.

Dr. Yael Margolin, president and chief executive officer of Gamida Cell, said, "The JV is planning to announce the safety and efficacy results of the Phase III StemEx trial in 2012 and to launch the product into the market in 2013. It is our hope that StemEx will provide the answer for the thousands of leukemia and lymphoma patients unable to find a matched, related bone marrow donor.”

Dr. Margolin continued, “StemEx may be the first allogeneic cell therapy to be brought to market. This is a source of pride for Gamida Cell, as it further confirms the company’s leadership as a pioneer in cell therapy. In addition to StemEx, Gamida Cell is developing a diverse pipeline of products for the treatment of cancer, hematological diseases such as sickle cell disease and thalassemia, as well as autoimmune and metabolic diseases and conditions helped by regenerative medicine.”

About Gamida Cell

Gamida Cell is a world leader in stem cell population expansion technologies and stem cell therapy products for transplantation and regenerative medicine. The company’s pipeline of stem cell therapy products are in development to treat a wide range of conditions including blood cancers such as leukemia and lymphoma, solid tumors, non-malignant hematological diseases such as hemoglobinopathies, acute radiation syndrome, autoimmune diseases and metabolic diseases as well as conditions that can be helped by regenerative medicine. Gamida Cell’s therapeutic candidates contain populations of adult stem cells, selected from non-controversial sources such as umbilical cord blood, which are expanded in culture. Gamida Cell was successful in translating these proprietary expansion technologies into robust and validated manufacturing processes under GMP. Gamida Cell’s current shareholders include: Elbit Imaging, Clal Biotechnology Industries, Israel Healthcare Venture, Teva Pharmaceutical Industries, Amgen, Denali Ventures and Auriga Ventures. For more information, please visit: http://www.gamida-cell.com.

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The Gamida Cell-Teva Joint Venture Concludes Enrollment for the Phase III Study of StemEx®, a Cord Blood Stem Cell ...

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today the dosing of third patient in its Phase 1/2 trial for Stargardt’s macular dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The patient was treated on Monday (Feb. 6) by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA) and retina division chief at UCLA’s Jules Stein Eye Institute. The outpatient transplantation surgery was performed successfully and the patient is recovering uneventfully.

“With the treatment of this third Stargardt’s patient at Jules Stein Eye Institute, we have now completed the treatment of the first cohort of patients under our clinical protocol for phase I/II of our U.S. SMD trial,” said Gary Rabin, chairman and chief executive officer of ACT. “We will continue to regularly monitor the three SMD patients in this trial, and by early spring anticipate review of their progress and safety-related data by the Data and Safety Monitoring Board (DSMB). With approval of the DSMB, we would then advance to the next cohort of patients and administer a higher dosage of RPE cells. In the context of all three trials we have running, this patient is the fifth person worldwide to be treated with our hESC-derived RPE cells. To date, there have been no complications or side effects due to the RPE cells, and we remain cautiously optimistic that our ongoing clinical programs will demonstrate the safety and tolerability of ACT’s stem cell-derived RPE cells.”

Each of the three clinical trials being undertaken by the company in the U.S. and Europe will enroll 12 patients, with cohorts of three patients each in an ascending dosage format. These trials are prospective, open-label studies, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with SMD or dry age-related macular degeneration (dry AMD) at 12 months, the study’s primary endpoint. Preliminary results relating to both early safety and biological function for the first two patients in the United States, one SMD patient and one dry AMD patient, were recently reported in The Lancet. On January 20, 2012, the first SMD patient to be enrolled in the Company’s U.K. clinical trial was treated at Moorfields Eye Hospital in London.

Further information about patient eligibility for the SMD study and the concurrent study on dry AMD is also available on www.clinicaltrials.gov; ClinicalTrials.gov Identifiers: NCT01345006 and NCT01344993.

About Stargardt's Disease

Stargardt’s disease or Stargardt’s Macular Dystrophy is a genetic disease that causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium, which is the site of damage that the company believes the hESC-derived RPE may be able to target for repair after administration.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the company’s periodic reports, including the report on Form 10-K for the year ended December 31, 2010. Forward-looking statements are based on the beliefs, opinions, and expectations of the company’s management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the company’s management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Company’s clinical trials will be successful.

Originally posted here:
ACT Announces Third Patient with Stargardt’s Disease Treated in U.S. Clinical Trial with RPE Cells Derived from ...

Stem cells grown from patients’ own cardiac tissue can heal damage once thought to be permanent after a heart attack, according to a study that suggests the experimental approach may one day help stave off heart failure.

In a trial of 25 heart-attack patients, 17 who got the stem cell treatment showed a 50 percent reduction in cardiac scar tissue compared with no improvement for the eight who received standard care. The results, from the first of three sets of clinical trials generally needed for regulatory approval, were published today in the medical journal Lancet.

“The findings in this paper are encouraging,” Deepak Srivastava, director of the San Francisco-based Gladstone Institute of Cardiovascular Disease, said in an interview. “There’s a dire need for new therapies for people with heart failure, it’s still the No. 1 cause of death in men and women.”

The study, by researchers from Cedars-Sinai Heart Institute in Los Angeles and Johns Hopkins University (43935MF) in Baltimore, tested the approach in patients who recently suffered a heart attack, with the goal that repairing the damage might help stave off failure. While patients getting the stem cells showed no more improvement in heart function than those who didn’t get the experimental therapy, the theory is that new tissue regenerated by the stem cells can strengthen the heart, said Eduardo Marban, the study’s lead author.

“What our trial was designed to do is to reverse the injury once it’s happened,” said Marban, director of Cedars- Sinai Heart Institute. “The quantitative outcome that we had in this paper is to shift patients from a high-risk group to a low- risk group.”

Minimally Invasive

The stem cells were implanted within five weeks after patients suffering heart attacks. Doctors removed heart tissue, about the size of half a raisin, using a minimally invasive procedure that involved a thin needle threaded through the veins. After cultivating the stem cells from the tissue, doctors reinserted them using a second minimally invasive procedure. Patients got 12.5 million cells to 25 million cells.

A year after the procedure, six patients in the stem cell group had serious side effects, including a heart attack, chest pain, a coronary bypass, implantation of a defibrillator, and two other events unrelated to the heart. One of patient’s side effects were possibly linked to the treatment, the study found.

While the main goal of the trial was to examine the safety of the procedure, the decrease in scar tissue in those treated merits a larger study that focuses on broader clinical outcomes, researchers said in the paper.

Heart Regeneration

“If we can regenerate the whole heart, then the patient would be completely normal,” Marban said. “We haven’t fulfilled that yet, but we’ve gotten rid of half of the injury, and that’s a good start.”

While the study resulted in patients having an increase in muscle mass and a shrinkage of scar size, the amount of blood flowing out of the heart, or the ejection fraction, wasn’t different between the control group and stem-cell therapy group. The measurement is important because poor blood flow deprives the body of oxygen and nutrients it needs to function properly, Srivastava said.

“The patients don’t have a functional benefit in this study,” said Srivastava, who wasn’t not involved in the trial.

The technology is being developed by closely held Capricor Inc., which will further test it in 200 patients for the second of three trials typically required for regulatory approval. Marban is a founder of the Los Angeles-based company and chairman of its scientific advisory board. His wife, Lisa Marban, is also a founder and chief executive officer.

To contact the reporter on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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Scarred Hearts Can Be Mended With Novel Stem Cell Therapy, Study Finds

COLUMBIA, SC (WIS) - Cutting-edge arthritis treatment for our four-legged family members is now available in Columbia.

Banks Animal Hospital is the first in the area to offer in-house Stem Cell therapy. It uses your pets own body to heal itself.

Take 13-year-old Maggie, for example. The energetic pup has a limp that usually keeps her from jumping or going up stairs.

"Today when everybody's out there filming her little limp it's not as pronounced because she wants to please," said Maggie's owner, Beth Phibbs. "She's just a great dog."

But a great attitude wasn't enough to repair a bad case of cervical spine arthritis.

So Monday, Beth brought Maggie to Banks Animal Hospital for the Stem Cell therapy. Like many, Beth had never heard of Stem Cell work in animals. "Until Dr. Banks mentioned it to me I was like, beg your pardon?"

"There's no down side, no side effects because you're using your own cells," said Dr Ken Banks.

Banks and his staff first gather some of Maggie's blood and fat. Both are good places to find the repair cells they're after. Adult stem cells, not the controversial embryonic kind, are then separated and spun down.

"The repair system in Maggie's body has failed," said Jason Richardson of MediVet-America. "It's fallen asleep at the wheel, we're taking these repair cells, activating them so a chronic condition like osteo arthritis to Maggie will now be an acute illness."

This kind of treatment used to take days with material being shipped across the country, but now it can be done in hours.

"The ability to do it same day, convenience, the ability to do it in clinic saves a lot of money to the doctor which he can then pass on to the patient," said Richardson.

The treatment will still run you around $2,000, but Richardson says that's half of what the similar treatment use to cost.

When it's over, Maggie should be able to live out her life pain and drug free -- something Phibbs is looking forward to.

"I'm hoping in a couple of weeks she's gonna have a new lease on life," said Phibbs.

Copyright 2012 WIS. All rights reserved.

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Vet offers stem cell therapy for dogs

WALKER, Mich. (WOOD) - Dogs who received the first in-clinic stem cell therapy in West Michigan returned to the vets who treated them Monday morning.

Boris and Natasha returned to Kelley's Animal Clinic for their 60-day checkup after receiving stem cell treatment in December 2011.

Dr. James Kelley and his staff of vets removed fat tissue from the dogs and activated it with an enzyme before injecting it into their back legs.

This adult animal stem cell technology is different from the controversial embryonic stem cell therapy.

Kelley said both dogs are doing amazingly well and that the procedure has done more than just help their arthritis.

"We're finding that not only the joints are affected, the rest of the animal is affected as well," said Kelley. "The skin is better. The attitude in these dogs is much improved."

Kelley and his staff have done 16 stem cell treatments since the first on Boris and Natasha, and he said all the dogs are showing signs of improvement after a short period of time.

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Dogs who got stem cell therapy are well

MONDAY, Feb. 13 (HealthDay News) -- Stem cell therapy's promise for healing damaged tissues may have gotten a bit closer to reality. In a small, early study, heart damage was reversed in heart-attack patients treated with their own cardiac stem cells, researchers report.

The cells, called cardiosphere-derived stem cells, regrew damaged heart muscle and reversed scarring one year later, the authors say.

Up until now, heart specialists' best tool to help minimize damage following a heart attack has been to surgically clear blocked arteries.

"In our treatment, we dissolved scar and replaced it with living heart muscle. Such 'therapeutic regeneration' has long been the holy grail of cell therapy, but had never been accomplished before; we now seem to have done it," said study author Dr. Eduardo Marban, director of the Cedars-Sinai Heart Institute in Los Angeles.

However, outside experts cautioned that the findings are preliminary and the treatment is far from ready for widespread use among heart-attack survivors.

The study, published online Feb. 14 in The Lancet, involved 25 middle-aged patients (average age 53) who had suffered a heart attack. Seventeen underwent stem cell infusions while eight received standard post-heart attack care, including medication and exercise therapy.

The stem cells were obtained using a minimally invasive procedure, according to the researchers from Cedars-Sinai and the Johns Hopkins Hospital in Baltimore.

Patients received a local anesthetic and then a catheter was threaded through a neck vein down to the heart, where a tiny portion of muscle was taken. The sample provided all the researchers needed to generate a supply of new stem cells -- 12 million to 25 million -- that were then transplanted back into the heart-attack patient during a second minimally invasive procedure.

One year after the procedure, the infusion patients' cardiac scar sizes had shrunk by about half. Scar size was reduced from 24 percent to 12 percent of the heart, the team said. In contrast, the patients receiving standard care experienced no scar shrinkage.

Initial muscle damage and healed tissue were measured using MRI scans.

After six months, four patients in the stem-cell group experienced serious adverse events compared with only one patient in the control group. At one year, two more stem-cell patients had a serious complication. However, only one such event -- a heart attack -- might have been related to the treatment, according to the study.

In a news release, Marban said that "the effects are substantial and surprisingly larger in humans than they were in animal tests."

Other experts were cautiously optimistic. Cardiac expert Dr. Bernard Gersh, a professor of medicine at Mayo Clinic, is not affiliated with the research but is familiar with the findings.

"This study demonstrates that it is safe and feasible to administer these cardiac-derived stem cells and the results are interesting and encouraging," he said.

Another specialist said that while provocative and promising, the findings remain early, phase-one research. "It's a proof-of-concept study," said interventional cardiologist Dr. Thomas Povsic, an assistant professor of medicine at the Duke Clinical Research Institute, in Durham, N.C.

And Dr. Chip Lavie, medical director of Cardiac Rehabilitation and Prevention at the John Ochsner Heart and Vascular Institute, in New Orleans, also discussed the results. He said that while the study showed that the cardiac stem cells reduced scar tissue and increased the area of live heart tissue in heart attack patients with moderately damaged overall heart tissue, it did not demonstrate a reduction in heart size or any improvement in the heart's pumping ability.

"It did not improve the ejection fraction, which is a very important measurement used to define the overall heart's pumping ability," Lavie noted. "Certainly, much larger studies of various types of heart attack patients will be needed before this even comes close to being a viable potential therapy for the large number of heart attack initial survivors."

Povsic concurred that much larger studies are needed. "The next step is showing it really helps patients in some kind of meaningful way, by either preventing death, healing them or making them feel better."

It's unclear what the cost will be, Povsic added. "What society is going to be willing to pay for this is going to be based on how much good it ends up doing. If they truly regenerate a heart and prevent a heart transplant, that would save a lot money."

Marban, who invented the stem cell treatment, said the while it would not replace bypass surgery or angioplasty, "it might be useful in treating 'irreversible' injury that may persist after those procedures."

As a rough estimate, he said that if larger, phase 2 trials were successful, the treatment might be available to the general public by about 2016.

More information

The U.S. National Heart, Lung, and Blood Institute describes current heart attack treatment.

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Stem Cell Treatment Might Reverse Heart Attack Damage

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today the dosing of third patient in its Phase 1/2 trial for Stargardt’s macular dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The patient was treated on Monday (Feb. 6) by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA) and retina division chief at UCLA’s Jules Stein Eye Institute. The outpatient transplantation surgery was performed successfully and the patient is recovering uneventfully.

“With the treatment of this third Stargardt’s patient at Jules Stein Eye Institute, we have now completed the treatment of the first cohort of patients under our clinical protocol for phase I/II of our U.S. SMD trial,” said Gary Rabin, chairman and chief executive officer of ACT. “We will continue to regularly monitor the three SMD patients in this trial, and by early spring anticipate review of their progress and safety-related data by the Data and Safety Monitoring Board (DSMB). With approval of the DSMB, we would then advance to the next cohort of patients and administer a higher dosage of RPE cells. In the context of all three trials we have running, this patient is the fifth person worldwide to be treated with our hESC-derived RPE cells. To date, there have been no complications or side effects due to the RPE cells, and we remain cautiously optimistic that our ongoing clinical programs will demonstrate the safety and tolerability of ACT’s stem cell-derived RPE cells.”

Each of the three clinical trials being undertaken by the company in the U.S. and Europe will enroll 12 patients, with cohorts of three patients each in an ascending dosage format. These trials are prospective, open-label studies, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with SMD or dry age-related macular degeneration (dry AMD) at 12 months, the study’s primary endpoint. Preliminary results relating to both early safety and biological function for the first two patients in the United States, one SMD patient and one dry AMD patient, were recently reported in The Lancet. On January 20, 2012, the first SMD patient to be enrolled in the Company’s U.K. clinical trial was treated at Moorfields Eye Hospital in London.

Further information about patient eligibility for the SMD study and the concurrent study on dry AMD is also available on www.clinicaltrials.gov; ClinicalTrials.gov Identifiers: NCT01345006 and NCT01344993.

About Stargardt's Disease

Stargardt’s disease or Stargardt’s Macular Dystrophy is a genetic disease that causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium, which is the site of damage that the company believes the hESC-derived RPE may be able to target for repair after administration.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the company’s periodic reports, including the report on Form 10-K for the year ended December 31, 2010. Forward-looking statements are based on the beliefs, opinions, and expectations of the company’s management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the company’s management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Company’s clinical trials will be successful.

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ACT Announces Third Patient with Stargardt’s Disease Treated in U.S. Clinical Trial with RPE Cells Derived from ...

ALACHUA, Fla.--(BUSINESS WIRE)--

AxoGen, Inc. (OTCBB: AXGN.OB - News), an emerging regenerative medicine company focused on the commercialization of proprietary products and technologies for peripheral nerve reconstruction and regeneration, today announced Jill Schiaparelli will be joining as its Senior Vice President of Business Strategy and Marketing.

“Strong sales growth is key to our continued success,” states Karen Zaderej, Chief Executive Officer of AxoGen, Inc. “Jill’s extensive strategic marketing and leadership experience in the healthcare space will add significant value to the team and will be ideal as we execute our growth initiatives.”

Prior to joining the team, Ms. Schiaparelli was a principal of JS Strategic Partners, a consultancy she founded to provide business strategy, growth initiatives, and commercialization implementation to healthcare companies and service providers. Jill also served as Global Vice President of Commercial Strategy & Business Development for ApaTech – a world leader in orthobiologics acquired by Baxter Healthcare. Earlier in her career, she held several senior positions in strategic marketing, sales operations, and analytics for the Johnson & Johnson family of companies and spent nearly a decade in investment banking.

Ms. Schiaparelli received her MBA from the Stern School of Business at New York University and a Bachelor’s of Science in Business Administration from Boston University.

About AxoGen, Inc.

AxoGen (OTCBB: AXGN.OB - News) is a regenerative medicine company with a portfolio of proprietary products and technologies for peripheral nerve reconstruction and regeneration. Every day people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body and their damage can result in the loss of function and feeling. In order to improve surgical reconstruction and regeneration of peripheral nerves, AxoGen has developed and licensed patented and patent-pending technologies, which are used in its portfolio of products. This portfolio includes Avance® Nerve Graft, which AxoGen believes is the first and only commercially available allograft nerve for bridging nerve discontinuities (a gap created when the nerve is severed). AxoGen’s portfolio also includes AxoGuard® Nerve Connector, a coaptation aid allowing for close approximation of severed nerves, and AxoGuard® Nerve Protector that protects nerves during the body’s healing process after surgery. AxoGen is bringing the science of nerve repair to life with thousands of surgical implants of AxoGen products performed in hospitals and surgery centers across the United States, including military hospitals serving U.S. service men and women.

AxoGen (formerly known as LecTec Corporation) is the parent of its wholly owned operating subsidiary, AxoGen Corporation. AxoGen’s principal executive office and operations are located in Alachua, FL.

Cautionary Statements Concerning Forward-Looking Statements

This Press Release contains “forward-looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations or predictions of future conditions, events or results based on various assumptions and management’s estimates of trends and economic factors in the markets in which we are active, as well as our business plans. Words such as “expects”, “anticipates”, “intends”, “plans”, “believes”, “seeks”, “estimates”, “projects”, “forecasts”, “may”, “should”, variations of such words and similar expressions are intended to identify such forward-looking statements. The forward-looking statements may include, without limitation, statements regarding product development, product potential or financial performance. The forward-looking statements are subject to risks and uncertainties, which may cause results to differ materially from those set forth in the statements. Forward-looking statements in this release should be evaluated together with the many uncertainties that affect AxoGen’s business and its market, particularly those discussed in the risk factors and cautionary statements in AxoGen’s filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and actual results may differ materially from those projected. The forward-looking statements are representative only as of the date they are made, and AxoGen assumes no responsibility to update any forward-looking statements, whether as a result of new information, future events or otherwise.

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AxoGen Names Jill Schiaparelli Senior Vice President of Business Strategy & Marketing

In Remaking Eden (Harper Perennial, 1998), geneticist Lee Silver envisioned a future in which humanity has split into two species: “Naturals,” the poor slobs who muddle along with the genes that nature gave them, and the “GenRich,” who can afford to boost their physical and mental talents via genetic engineering. Silver warns that over time, “the genetic distance between the Naturals and the GenRich has become greater and greater, and now there is little movement up from the Natural to GenRich class.”

We don’t have to wait until science catches up to science fiction for this unjust dystopia to be realized. It’s happening now, in the United States, as a result of policies that favor the rich at the expense of un-rich. Scholars are confirming with empirical studies what Occupy Wall Street protesters have been saying: our system is unfairly rigged in favor of the haves, who keep pulling away from have-nots.

Education can help the poor climb their way to a higher socioeconomic status. But according to Sabrina Tavernise of The New York Times, several studies have shown that “the achievement gap between rich and poor children is widening, a development that threatens to dilute education’s leveling effects.”

Race plays less of a role than it once did in this widening chasm. A study published last year by sociologist Sean Reardon found that the difference between standardized test scores of blacks and whites has narrowed since 1960, while the difference between low-income and wealthy students has surged 40 percent. “We have moved from a society in the 1950s and 1960s,” Reardon told The Times, “in which race was more consequential than family income, to one today in which family income appears to be more determinative of educational success than race.”

The simplest explanation for the divide is that the rich can afford to send their children to better schools, hire private tutors for them and give them other advantages. In 1972, affluent parents spent five times as much on their children, on average, as low-income parents; by 2007, that difference had almost doubled, to nine to one. “The pattern of privileged families today is intensive cultivation,” sociologist Frank Furstenberg told The Times.

The federal tax code is also stacked against the poor. The code caps taxes on long-term capital gains and dividends at 15 percent, which is why Mitt Romney is taxed at a lower rate than a grade-school teacher. Far from being progressive, with percentages rising with income, the tax code is regressive in this key area. Those who work for a living pay more in taxes, percentage-wise, than those who live off investments.

Political scientist Andrew Hacker documents the depths of our inequality in “We’re More Unequal Than You Think,” in The New York Review of Books this month. He estimates that since 1985 “the lower 60 percent of households have lost $4 trillion, most of which has ascended to the top 5 percent.” U.S. economic policies, Hacker says, now serve as a “giant vacuum cleaner” sucking money from low-income people and showering it upon the rich.

Economists quantify the inequality of a society on a scale called the Gini index. If everyone has the same income, the Gini index is zero; if one person makes all the moola, the Gini index is one. The U.S. Gini index has risen from .359 in 1972 to .440 in 2010, an increase of more than 20 percent, Hacker reports. In contrast, the Gini index of socialist Sweden is .230.

Hacker notes that “in a not-so-distant past, families of modest means made enough to put something aside for their children’s college fees. That cushion is gone, which is why millions of undergraduates are now forced to take much larger loans. Adding interest and penalties, many will face decades paying off six-figure debts.” (I’m facing this financial challenge myself; my son is entering college next fall and my daughter a year later.)

The U.S. exemplifies the Matthew effect, a sociological term that alludes to a passage in the Gospel of Matthew: “For to all those who have, more will be given, and they will have an abundance; but from those who have nothing, even what they have will be taken away.”

Our current presidential race features several Christian candidates—Rick Santorum, Newt Gingrich and Romney—who seem to view the Matthew effect as the Eleventh Commandment. These men trumpet their religiosity and rectitude, and yet they advocate economic policies that benefit the rich and hurt the poor, violating the most basic rules of moral decency. Naturals must join together with rich people with a conscience to create a more economically just society.

Image courtesy Wikimedia Commons, http://www.flickr.com/tracy_olson.

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Education Isn't Helping Americans Overcome Deepening Inequality

Public release date: 13-Feb-2012
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Contact: Cathia Falvey
cfalvey@liebertpub.com
914-740-2100
Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY -- Children are naturally drawn toward gaming and other types of technology, creating an ideal opportunity to design interactive media tools to encourage physical activity and promote healthy eating habits, according to an article in a special issue of the journal Childhood Obesity celebrating the second anniversary of First Lady Michelle Obama's Let's Move! initiative. The issue includes a special Foreword by Mrs. Obama and is available free online at http://www.liebertpub.com/chi.

"Let's Get Technical! Gaming and Technology for Weight Control and Health Promotion in Children," an article by Tom Baranowski, PhD and Leslie Frankel, PhD, USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine, Houston, Texas, describes the ongoing research effort to identify and develop the most effective approaches for using gaming and interactive media to deliver health promotion messages to children of all ages.

This special Let's Move! issue has a wide range of contributions from leaders in the fight against childhood obesity including Secretary of Agriculture Tom Vilsack, NFL quarterback Drew Brees, Stephen Daniels, MD, PhD, Sandra Hassink, MD, Margo Wootan, DSc, and Editor-in-Chief David Katz, MD, MPH.

The issue covers a broad range of topics including creating environments that support routine physical activity and a healthy lifestyle, after-school obesity prevention programs, nutrition standards for school meals, faith-based advocacy efforts to end childhood obesity, gaming and technology for weight control, parent training programs for 2-4 year old Latino children, the role of sleep in childhood obesity, a roundtable discussion about what we don't know about childhood obesity, industry efforts to help children make healthy food choices, and success stories from the Let's Move! initiative.

"We know that 'screen time' is a contributor to childhood obesity. But we also know it's not going away. Thought leaders like Dr. Baranowski are showing how to convert parts of the problem into parts of the solution," says David L. Katz, MD, MPH, Editor-in-Chief of Childhood Obesity and Director of Yale University's Prevention Research Center. "We are honored to feature such pragmatic expertise on the pages of the Journal."

###

Childhood Obesity is partly funded by a grant from the W.K. Kellogg Foundation to ensure that the Journal is accessible as widely as possible, and to provide a framework that addresses the social and environmental conditions that influence opportunities for children to have access to healthy, affordable food and safe places to play and be physically active.

Childhood Obesity is a bimonthly journal, published in print and online, and the journal of record for all aspects of communication on the broad spectrum of issues and strategies related to weight management and obesity prevention in children and adolescents. The Journal includes peer-reviewed articles documenting cutting-edge research and clinical studies, opinion pieces and roundtable discussions, profiles of successful programs and interventions, and updates on task force recommendations, global initiatives, and policy platforms. It reports on news and developments in science and medicine, features programs and initiatives developed in the public and private sector, and a Literature Watch. Tables of content and a free sample issue may be viewed online T http://www.liebertpub.com/chi.

Mary Ann Liebert, Inc. is a privately held, fully integrated media company known for establishing authoritative medical and biomedical peer-reviewed journals, including Games for Health Journal, Telemedicine and e-Health, Population Health Management, Diabetes Technology & Therapeutics, and Metabolic Syndrome and Related Disorders. Its biotechnology trade magazine, Genetic Engineering & Biotechnology News (GEN), was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's 70 journals, newsmagazines, and books is available on our website at http://www.liebertpub.com.

Mary Ann Liebert, Inc.
140 Huguenot St., New Rochelle, NY 10801-5215
Phone: 914-740-2100
800) M-LIEBERT
Fax: 914-740-2101
http://www.liebertpub.com

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Games and interactive media are powerful tools for health promotion and childhood obesity prevention