MOUNTAIN VIEW, Calif., March 20, 2012 /PRNewswire/ -- SanBio Inc. today announced the successful enrollment of the first dose cohort of patients in its Phase 1/2a clinical trial testing the safety and efficacy of a novel allogeneic stem cell therapy product, SB623, in patients suffering from chronic deficits resulting from previous stroke injuries. The first 6 patients, of a total of 18, have been successfully administered SB623. The trial is being conducted at Stanford University and the University of Pittsburgh. No safety concerns have been reported. For details regarding this clinical trial, please refer to http://www.strokeclinicaltrial.org.

SB623 is derived from adult bone marrow and has shown safety and efficacy in rodent models of chronic stroke. "This represents a major milestone in the human clinical testing of this important new approach for regenerative medicine", said Keita Mori, SanBio CEO. "We are pleased to learn that the initial dose level was well tolerated."

SB623 is being delivered to the damaged region of the brains of patients who have suffered an ischemic stroke. Product safety is the primary focus of the study but various measurements of efficacy are also being tested.

"The successful completion of the initial dose cohort is a major step in any first-in-human study", said Dr. Ernest Yankee, SanBio's Vice President of Development. "We are looking forward to initiating the next two dose cohorts and wrapping up the study. The safety findings thus far are very encouraging"

About SB623: SB623 is a proprietary cell therapy product consisting of cells derived from genetically engineered bone marrow stromal cells obtained from healthy adult donors. SB623 is administered adjacent to the area damaged by stroke and functions by producing proteins that aid the regenerative process.

About SanBio: SanBio is a privately held San Francisco Bay Area biotechnology company focused on the discovery and development of new regenerative cell therapy products.

For more information: http://www.san-bio.com

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SanBio Announces Enrollment of First Cohort of Patients in Its Clinical Trial of Stem Cell Therapy for Chronic Stroke

Recommendation and review posted by Bethany Smith

A special dog used to help people is getting some much-needed help of her own at a Virginia clinic, myFOXdc.com reported.

Red, a 12-year-old black Labrador, is one of the last surviving search and rescue dogs deployed during the 9/11 attacks.

Her handler, Heather Roche, told WTTG-TV that Red was recently certified when Sept. 11, 2001, occurred, and the devastating terror attacks were her first big mission.

Red's job was to find DNA evidence at The Pentagon's north parking lot with 26 other dogs, and according to Roche, she did a "fantastic job."

"I got her as a puppy ... You have to convince [her] everything that she does, whether it's climbing ladders or any kind of search, that it's her idea," Roche told WTTG-TV. "No matter what I've asked her to do, she's done it and she's done it flawlessly."

But in her old age Red developed crippling arthritis, and underwent stem cell regenerative therapy Monday to help ease her pain so she can get back out on the job.

Dr. John Herrity of Burke Animal Clinic in Burke, Va., told WTTG-TV, "Red has a back issue that, after a fall from a ladder has not really been right, and has been living in pain, so we're going to give those stem cells IV [intravenously] and then also inject them along the back to try to help Red's comfort."

"She's had a great career and has made a difference to a lot of families by bringing their loved ones home," Roche said.

Click here to read more.

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9/11 search and rescue dog receives stem cell therapy

Recommendation and review posted by Bethany Smith

GOLDEN, Colo., March 20, 2012 (GLOBE NEWSWIRE) -- Vitro Diagnostics, Inc. (OTCQB:VODG.PK - News), dba Vitro Biopharma, has recently received approval for its presentation entitled "GMP Cell Culture Media for Expansion of MSCS Prior to Allogeneic or Autologous Transplantation." The Company recently expanded its stem cell media products to include clinical grade MSC-Gro(TM) media for use in clinical trials of stem cells. The Company will present its current findings at the annual meeting of the International Society of Cellular Therapy (ISCT) in Seattle, Washington this coming June. To get more information regarding the International Society of Cellular Therapy visit http://www.celltherapysociety.org/

Vitro Biopharma has developed a series of products to support clinical application of adult stem cells known as mesenchymal stem cells (MSCs) that are completely divorced and different from ethically contentious embryonic stem cells. MSCs are derived from numerous adult tissue sources including bone marrow, blood, adipose tissue, teeth, etc and show considerable promise in clinical applications especially for treatment of injury and diseases affecting joints, bone, ligaments and tendons. There are over 200 ongoing clinical trials of MSCs to study potential treatment of diabetes, Parkinson's disease, organ transplant rejection, osteoarthritis, MS, spinal cord injury, stroke, myocardial infarction, cardiovascular disease, liver degeneration, COPD and other medical conditions.

Vitro Biopharma will present the current status of its clinical grade MSC-Gro(TM) Brand of culture medium for growth and differentiation of MSCs at the ISCT meeting. Through its extensive research and experience with cell culture media, Vitro Biopharma has developed highly competitive media that is suitable for clinical applications. Critical characteristics are that they are serum-free, chemically-defined and free from animal-derived components. Furthermore, it is essential that serum-free media perform the same as formulations containing contain blood serum, a complex mixture of biologically active components with intrinsic variability from batch to batch and safety issues regarding potential infectious agents. Vitro will present its results regarding each of these points and the status of FDA approval of its clinical products.

Dr. Jim Musick, Vitro's President & CEO, said, "We are very pleased to be approved for presentation at the ISCT Annual Meeting. It is apparent from the reported widespread efficacy of MSCs in clinical trials and the low incidence of adverse effects that there is potential to achieve regulatory approval for advanced treatment of many diseases, injuries and cellular degenerative conditions. Our new clinical products expand our offering of tools to support stem cell research by providing highly competitive new products for clinical studies including our serum-free, animal-free and chemically defined MSC-Gro(TM) Brand of media formulations optimized for human MSC self-renewal & lineage-specific differentiation, together with LUMENESC(TM) high performance assays of stem cell quality, potency and response to toxic agents. We intend to leverage our current advances in human medical MSC-based treatments to offer products for treatment of horses, dogs and cats. The results of MSC therapy in animals may also provide safety and efficacy data to support human clinical studies."

About Vitro Diagnostics, Inc.

Vitro Diagnostics, Inc. dba Vitro Biopharma (OTCQB:VODG.PK - News) (http://www.vitrobiopharma.com), owns US patents for production of FSH, immortalization of pituitary cells, and a cell line that produces beta islets for use in treatment of diabetes. Vitro also owns a pending international patent for generation of pluripotent stem cells. Vitro's mission is "Harnessing the Power of Cells(TM)" for the advancement of regenerative medicine to its full potential. Vitro operates within a modern biotechnology manufacturing, R&D and corporate facility in Golden, Colorado. Vitro manufactures and sells "Tools for Stem Cell and Drug Development(TM)", including human mesenchymal stem cells and derivatives, MSC-Gro(TM) optimized media for stem cell self-renewal and lineage-specific differentiation. Vitro recently formed a strategic alliance with HemoGenix(R), Inc. (http://www.hemogenix.com/) to jointly manufacture and distribute LUMENESC(TM) and LumiSTEM(TM) quantitative assays for determination of stem cell quality, potency and response to toxic agents.

The Vitro Biopharma logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=12086

Safe Harbor Statement

Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward looking statements are identified by words such as "intends," "anticipates," "believes," "expects" and "hopes" and include, without limitation, statements regarding the Company's plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company's products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company's filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward looking statements, whether as a result of new information, future events or otherwise.

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Vitro Biopharma Receives Approval for Presentation to the International Society for Cellular Therapy

Recommendation and review posted by Bethany Smith

NEW YORK, March 20, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE Amex:NBS) ("NeoStem" or "the Company") is a leader in the cell therapy industry, developing cell based therapeutics supported by the Company's expertise in contract manufacturing. This strategic combination and depth of experience in cell therapy development and manufacturing provide NeoStem with unique capabilities to develop its own cell therapies and that sets the Company apart from others in the cell therapy landscape. 2011 represented a major year of strategic transition for NeoStem, and the Company plans to build upon that in 2012 and in the years ahead.

NeoStem reported its audited results for 2011. Consolidated revenues for the year ended December 31, 2011 were $73.7 million compared to $69.8 million for 2010. The Company's consolidated net loss for 2011 was $56.6 million, which included $10.3 million of non-cash equity-based compensation expense, $19.4 million of goodwill impairment charges and $9.0 million of depreciation and amortization. Overall, the Company's consolidated cash loss for 2011 was $15.5 million (see reconciliation below). Net loss attributable to NeoStem common shareholder interests for 2011 was $47.8 million, or $0.54 per share.

As of December 31, 2011, the Company had consolidated cash and cash equivalents of $12.7 million, and an additional $2.5 million in cash held in escrow (classified in Other Assets).

NeoStem believes that the opportunities that exist today in cell therapy are robust and growing despite a persistently difficult financial environment, making this an opportunistic time to pursue the monetization of the Company's 51% ownership of Suzhou Erye Pharmaceutical Co., Ltd. and bolster its cell therapy business. In June 2011, the Company engaged a financial advisor to lead the effort to pursue the possible divestiture of the Company's interest in Erye. Marketing efforts are underway and have generated interest from both financial and strategic buyers.

On the therapeutics side of the business NeoStem now has a pipeline of assets that includes Amorcyte (Phase 2 trial for preservation of heart function after a heart attack), Athelos (physician sponsored Phase 1 trials for a range of auto-immune conditions) and pre-clinical development work on its VSEL(TM) technology. The Company's most advanced asset is AMR-001 for the treatment of acute myocardial infarction for which enrollment for a Phase 2 study in the United States commenced in January. The study is a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of infarct-related artery infusion of AMR-001, an autologous bone marrow derived cell therapy enriched for CD34+ cells. AMR-001 is administered 5 to 11 days post-stent placement in patients diagnosed with an ST segment elevation myocardial infarction ("STEMI") with ejection fraction less than or equal to 48%. The study will include 160 subjects, age 18 and older, randomized 1:1 between treatment and control. The manufacturing, product supply, and logistics for the trial will be supported by Progenitor Cell Therapy, LLC, NeoStem's contract manufacturing company.

Amorcyte currently has ten activated clinical trial sites for its Phase 2 AMI clinical trial with the initial patients enrolled. Trial enrollment is expected to be completed in approximately one year with data read out six months following the last treated patient. The Amorcyte franchise is supported by a strong patent portfolio which includes both composition of matter and methods of treatment around use of these hematopoietic stem cells for treatment of cardiac ischemia and other ischemic tissue that result from vascular insufficiency. The Company sees Amorcyte as a pipeline of therapeutics with potential in multiple indications from STEMI to congestive heart failure and other related vascular insufficiencies. The Amorcyte product addresses both an unmet medical need and a large potential market.

"One of the most important attributes of AMR-001 is that it's 'natural.' We are enhancing the body's normal and natural response to ischemic injury," said Dr. Robin Smith, CEO of NeoStem. "Ample historical evidence, published literature and our own compelling Phase 1 data give us confidence that this product will ultimately make it to the marketplace. Our next most advanced asset is held by Athelos Corporation, (a NeoStem company, partnered with Becton, Dickinson and Company) which is developing a novel T-cell platform for immunological disorders. The Athelos T-cell technology represents an innovative approach to restoring immune balance with potential applications in graft vs. host disease (GvHD), solid organ transplant (SOT) and autoimmune diseases, such as asthma and diabetes. Multiple physician sponsored phase 1 studies are expected to report results that will be used to determine the direction of clinical development.

"NeoStem is also developing pre-clinical assets, including its VSEL(TM) Technology platform for regenerative medicine, which NeoStem believes is an endogenous pluripotent non-embryonic cell that has the potential to change the paradigm of cell therapy as we know it today. These activities have received awards in excess of $2.5 million which funds support the work of prestigious researchers who are pioneering this science with NeoStem.

"Behind the development of these therapeutic assets is the NeoStem cell therapy contract manufacturing business (PCT) which itself continues to grow. New clients have engaged PCT to assist them in the development of their products, including a global, diversified healthcare company who recently selected PCT to provide stem cell processing in our two GMP manufacturing facilities in the United States (California and New Jersey). PCT's prominence in the marketplace continues to grow and that is reflected by both client satisfaction and the revenues the company generates.

"As we look to the year ahead, we are excited on multiple fronts. Our capital preservation efforts are now bearing fruit as our cash burn rate is in-line with our peers. We expect to continue to carefully invest our capital in projects that meet our internal rate of return hurdle and risk parameters. We believe the PCT and Amorcyte acquisitions have created true value for our shareholders and we look forward to demonstrating that as these assets reach their respective value inflection points. We see the unmet medical need in cardiology and the treatment burden associated with chronic diseases as representing a significant challenge to modern society. We believe that cell therapy holds many of the solutions to the health crisis that societies face and have the potential to create real pharmacoeconomic benefit as well as shareholder value for our company.

The rest is here:
NeoStem Provides Updates and Reports Year End Results

Recommendation and review posted by Bethany Smith

TUESDAY, March 20 (HealthDay News) -- A novel technique that uses a kidney transplant recipient's own stem cells may someday replace or reduce the initial use of anti-rejection medications, new research suggests.

Six months after receiving a kidney transplant, only about 8 percent of people given their own mesenchymal stem cells experienced rejection compared with almost 22 percent of people on the standard anti-rejection drugs, according to the study.

"Mesenchymal stem cells are stem cells that can be differentiated into a variety of cells," explained Dr. Camillo Ricordi, study senior author and director of the Cell Transplant Center and Diabetes Research Institute at the University of Miami Miller School of Medicine.

"If you infuse mesenchymal stem cells at the time of the transplant, you could replace the use of powerful anti-rejection drugs, and maybe replace immunosuppressants altogether," he said. This technique could be used in the transplantation of islet cells (in the pancreas) for people with type 1 diabetes, and for other organ transplants, such as the liver, he added.

The people given their own stem cells also had improved kidney function earlier after transplant, Ricordi said.

Results of the study appear in the March 21 issue of the Journal of the American Medical Association.

One of the biggest remaining hurdles in organ transplantation remains the need for powerful anti-rejection and immune-suppressing medications after the transplant.

"Basically, the way we prevent kidney rejections is by putting you on very powerful anti-rejection drugs and immunosuppressive agents to prevent your cells from attacking the foreign organ," said Dr. Robert Provenzano, chair of the department of nephrology, hypertension and transplantation at St. John Providence Health System in Detroit. "But, the current standard has some problems, like an increased risk of infections and the possibility of creating a cancer."

The body's immune system sends out surveillance cells to protect the body against foreign invaders, such as a bacteria, virus or, in this case, a new organ, Provenzano said. The current method of preventing these cells from attacking the new organ is essentially to destroy the surveillance cells. But mesenchymal cells can naturally suppress those surveillance cells so they don't attack, he said.

To see if this suppression would be enough to prevent rejection, Ricordi and his colleagues, including researchers from Xiamen University in China, recruited 159 people with serious kidney disease who were on dialysis. They ranged in age from 18 to 61.

Continued here:
Stem Cell Therapy Could Boost Kidney Transplant Success: Study

Recommendation and review posted by Bethany Smith

NEWARK, Calif., March 20, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM - News) and genOway (NYSE:ALGEN) announced today that they have entered into a license agreement under which StemCells has granted genOway a worldwide, exclusive license to StemCells' Internal Ribosome Entry Site (IRES) technology for use in the development and commercialization of genetically engineered mice. Financial conditions were not disclosed.

The IRES technology enables the dual expression of a protein of interest and a selectable marker, thereby enabling researchers to genetically modify any mammalian cell and monitor the activity of a particular gene of interest in living cells or tissues without blocking the normal function of the gene. The IRES technology is particularly important for evaluating the success of gene knock-outs or knock-ins in stem cells and for the successful creation of transgenic rodent disease models. The IRES technology has been used to develop hundreds of genetically modified models in the past decade, and the technology is now considered to be the reference technology for transgene expression in some key rodent animal models, such as humanized models, reporter models, and cell trafficking models.

"We are very happy to have entered this license agreement with genOway, who are well-recognized for their experience and expertise in the field of genetically engineered mouse models," said Martin McGlynn, President and CEO of StemCells, Inc. "This exclusive license gives genOway a very powerful and unique tool to expand their product offerings to the research market."

"We are proud to be the only company or institution in the world able to sell IRES mouse models," said Alexandre Fraichard, CEO of genOway. "This technology is already frequently used for transgenic research, and this license represents a clear competitive advantage as it strengthens our proprietary technology portfolio and increases the uniqueness of our commercial offerings. As the leader in the development of sophisticated and highly predictable genetically modified rodents, genOway is well positioned to bring this unique technology to any scientist worldwide, in academia or industry, and we will guarantee our customers the freedom to operate for their R&D activities."

About StemCells, Inc.

StemCells, Inc. is engaged in the research, development, and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery. The Company's lead therapeutic product candidate, HuCNS-SC(R) cells (purified human neural stem cells), is currently in development as a potential treatment for a broad range of central nervous system disorders. The Company recently completed a Phase I clinical trial in Pelizaeus-Merzbacher disease (PMD), a fatal myelination disorder in children, and the trial data will be reported in late March. The Company is also conducting a Phase I/II clinical trial in chronic spinal cord injury in Switzerland and has received authorization from the FDA to initiate a Phase I/II clinical trial in dry age-related macular degeneration (AMD). In addition, the Company is pursuing preclinical studies of its HuCNS-SC cells in Alzheimer's disease. StemCells also markets stem cell research products, including media and reagents, under the SC Proven(R) brand. Further information about StemCells is available at http://www.stemcellsinc.com.

The StemCells, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7014

About genOway

genOway (NYSE:ALGEN) is a biotechnology company developing genetically modified and high value-added research models for the bio-pharmaceutical, chemical, agrochemical and food industry as well as for academic research. With highly qualified scientific personnel, the company has a work force of 60 people and operates in over 25 countries in Europe, Asia and North America, supplying more than 260 academic institutes and 80 biopharmaceutical companies. genOway is a leader in its market in terms of both size and customer portfolios. The company's development is founded upon both a broad and exclusive technology platform as well as strong intellectual property rights combining patents and licensing agreements. Taking advantage of the global trend towards outsourcing the production of genetically modified research models, genOway has signed many contracts with leaders of the pharmaceutical industry (Pfizer, Bayer, Boehringer Ingelheim, etc.), and with the most prestigious academic research centers (King's College and the University of Manchester, in England; Duke University and the National Institutes of Health, in the United States; the Institut Pasteur, in France; NGFN and the Max Planck Institutes, in Germany, etc.). To strengthen its technological position and benefit from worldwide business partners, genOway has signed strategic alliances with leading companies in their field: Charles River Laboratories (NYSE:CRL - News), (a world leader in supplying laboratory animals), Invitrogen (Nasdaq:IVGN), (world leader in supplying molecular biology reagents).

For more information please go to http://www.genoway.com.

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StemCells, Inc. Grants genOway Exclusive License to Gene Insertion Technology for Genetically Engineered Mice

Recommendation and review posted by Bethany Smith

XYRCOS Provides Advanced Research Capabilities in a Sleek New Design With Improved Fluorescence, Optics and RED-i Target Locator Built Directly Inside Microscope Objective

BEVERLY, MA and TORONTO--(Marketwire - Mar 20, 2012) - Hamilton Thorne Ltd. (TSX VENTURE: HTL), a leading provider of precision laser devices and advanced imaging systems for the fertility, stem cell and developmental biology research markets, today announced the launch of its leading-edge XYRCOS laser system for advanced research applications. The XYRCOS laser offers a significant advance in integrated laser optics, providing additional functionality, increased resolution and compatibility with all major microscope models.

The elegant and sleek new design of the XYRCOS is engineered to have the laser and RED-i target locator built directly inside the objective, providing unparalleled precision while saving researchers from tedious alignment procedures. The improved working distance of the XYRCOS laser objective provides researchers with more compatibility and flexibility to integrate with existing laboratory equipment. The laser also features enhanced UV transmission/fluorescence, which is compatible with many fluorescing stains used in advanced research applications. The XYRCOS offers additional benefits for cutting-edge embryo micromanipulation applications such as the creation of transgenic animals, gene targeting, and stem cell research including blastocyst injection, 8-cell injection, and laser-assisted animal model IVF.

"Built on the same hardware platform as our popular turret-mounted lasers, the new XYRCOS offers researchers an elegant laser design that enables intricate and delicate cell micromanipulation capabilities. Already installed at some of our industry-leading beta site customers, the XYRCOS laser has been used in some of today's most advanced and celebrated scientific research," said David Wolf, President, Chief Executive Officer of Hamilton Thorne Ltd. "The improved image quality, better working distance and enhanced fluorescence provides researchers with significant advantages in working with advanced applications such as stem cell research and developmental biology, and has already proven effective in important research studies such as reprogramming cells."

"With its compact design, long working distance and excellent optics, the new XYRCOS laser provides a flexible research tool that can be used with any lab microscope and fits easily into the current daily workflow," said Diarmaid Douglas-Hamilton, Chief Technology Officer, Senior Vice President of Research & Development and Co-founder of Hamilton Thorne. "The improved fluorescence has been especially useful in the lab since the XYRCOS installs directly onto the turret, leaving both the fluorescence and filter cube ports free for normal use, providing significant advantages in how cells can be viewed and analyzed."

The XYRCOS laser system will be available in both 40X and 20X objectives, and will also have the popular Staccato multi-pulse laser activation software as an additional feature option. Due to its smaller footprint, the XYRCOS allows full use of the turret and fits into all major microscopes, including newer and upright microscopes. The XYRCOS is available for non-clinical research use only.

About Hamilton Thorne Ltd. (www.hamiltonthorne.com)

Hamilton Thorne designs, manufactures and distributes precision laser devices and advanced imaging systems for the fertility, stem cell and development biology research markets. It provides novel solutions for Life Science that reduce cost, increase productivity, improve results and enable research breakthroughs in regenerative medicine, stem cell research and fertility markets. Hamilton Thorne's laser products attach to standard inverted microscopes and operate as robotic micro-surgeons, enabling a wide array of scientific applications and IVF procedures. Its imaging systems improve outcomes in human IVF clinics and animal breeding facilities and provide high-end toxicology analyses.

Hamilton Thorne's growing customer base includes pharmaceutical companies, biotechnology companies, fertility clinics, university research centers, and other commercial and academic research establishments worldwide. Current customers include world-leading research labs such as Harvard, MIT, Yale, McGill, DuPont, Monsanto, Charles River Labs, Jackson Labs, Merck, Novartis, Pfizer, and Oxford and Cambridge.

Neither the Toronto Venture Exchange, nor its regulation services provider (as that term is defined in the policies of the exchange), accepts responsibility for the adequacy or accuracy of this release.

Excerpt from:
Hamilton Thorne Launches XYRCOS(TM) Laser System for Research Applications Including Stem Cell Research, Gene ...

Recommendation and review posted by Bethany Smith

Murray Close / Lionsgate / Everett Collection

Peacekeepers escort Katniss Everdeen (Jennifer Lawrence) in a scene from "The Hunger Games."

By Alan Boyle

The technological divide between the rulers and the ruled is at the heart of "The Hunger Games": While the good guys struggle to survive, the bad guys employ fictional gee-whiz technologies inspired by real-life frontiers. And just as in real life, technology gets tripped up by unintended consequences.

That's not to say the post-apocalyptic North America of the book series and the much-anticipated movie, opening Friday, is anything close to real life. On one level, the technologies used by the villainous government of the nation known as Panem, ranging from force fields to extreme genetic engineering, serve as science-fiction plot devices and special effects. But on another level, the contrast between bows and arrows on one side, and death-dealing hovercraft on the other, accentuates the saga's David vs. Goliath angle or, in this case, Katniss vs. the Capitol.

Here are a few of the technological trends that provide the twists in "The Hunger Games," along with real-world analogs:

What? No cellphones? Much has been made of the fact that the starving, downtrodden residents of Panem's districts don't seem to have access to cellphones or the Internet. Instead, they have to huddle around giant television sets to find out what their overlords in the Capitol want them to see. But if you think of Panem as a fictional tweak of modern-day North Korea, "The Hunger Games" might not be that far off the mark: You've got a leadership capable of long-range missile launches, exercising virtually total control over what its impoverished populace sees and hears. Cellphones were outlawed until 2008, and even today they're confiscated from international visitors upon arrival. Internet access and international calling are limited to the elite.

The outlook for change is mixed: Today, a million North Koreans are said to be using mobile phones, but the State Department's Alec Ross told the Korea Times during a recent visit to Seoul that "it will be very difficult for technology to drive change in North Korea, given the extreme measures that North Korea has taken to create a media blackout." That's life in Panem ... er, Pyongyang.

Genetic engineering The most vivid special effects are connected to genetic engineering of various organisms, including humanized animals. To minimize the plot-spoiler effect, the only "muttation" I'll mention in detail is the mockingjay, which figures so prominently in the advance publicity and provides the title for the third book in Suzanne Collins' "Hunger Games" trilogy. The geniuses at the Panem high command created genetically modified birds known as jabberjays that were able to listen in on rebel conversations and report them back to the authorities. When the rebels caught onto this, they started feeding the jays false information. And when the Capitol figured this out, they left the jabberjays to fend for themselves. Male jabberjays mated with female mockingbirds, resulting in birds that could learn and repeat musical notes but not human speech.

The twist illustrates a time-honored movie maxim about genetic engineering, enunciated in the first "Jurassic Park" film: "Life will not be contained." That may be putting it too simply, but the field has certainly raised a lot of questions about how to keep genetic genies in the bottle. This month, more than 100 groups issued a call to hold back on synthetic biology until new guidelines are drawn up.

Follow this link:
Get a reality check on 'Hunger Games' tech

Recommendation and review posted by Bethany Smith

A noted soybean plant developer will discuss "Genomics in the Age of Plant Breeding" on April 4 at the University of Nebraska.

Phillip E. McClean works on dry bean genetics and biotechnology and is the director of the Genomics and Bioinformatics Program at North Dakota State University in Fargo.

His lecture is part of the Dermot P. Coyne Graduate Student Distinguished Lectureship Series. The 1 p.m. lecture in the Nebraska East Union is free and open to the public. A reception will follow.

McClean received his doctorate and master's degrees in agronomy from Colorado State University. He has been a member of the NDSU faculty in the Department of Plant Sciences since 1985 and has been director of the Genomics and Bioinformatics Program since 2002.

His lecture will review the history of the plant breeding industry and how genomic science provides new data for plant breeding. This latest data provides new directions and challenges.

In his lecture abstract, McClean wrote, "A major challenge for crop improvement efforts is to develop approaches that effectively incorporate that new knowledge into current breeding practices, and to modify breeding programs to maximize the utility of genomic information."

McClean's visit is courtesy of the Coyne Lectureship Series which was established by Dermot P. Coyne in the area of plant breeding and genetics. Coyne, a George Holmes Professor of Agronomy and Horticulture in the Institute of Agriculture and Natural Resources, developed new varieties of dry edible beans and squash while a plant breeder at UNL for more than 40 years.

He released many popular dry bean varieties in support of the Nebraska and High Plains bean industry. Coyne, who died in 2002, also developed several varieties of pinto, pompadour and great northern beans that were resistant to bean common mosaic virus, rust, common bacterial blight and other bacterial diseases.

His disease-resistant germplasm releases and varieties are parents of numerous bean varieties grown in the Americas, Africa, Asia and Europe.

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Plant breeding, genetics to be discussed at UNL

Recommendation and review posted by Bethany Smith

Testing at a glance

Comprehensive BRCA analysis

What: Testing (via blood or saliva) to find mutations in BRCA1 and BRCA2 genes that increase the risk of breast and ovarian cancers. Cost: Can be more than $3,300 (more targeted testing can cost less). Covered by insurance? Sometimes. Where to get it? Ask your doctor.

Sources: Baptist Hospital East in Louisville, Ky. and Norton Cancer Institute

Having a genetic test may help you: Make medical and lifestyle choices. Clarify your cancer risk. Decide whether to have risk-reducing surgery. Give other family members useful information (if you choose to share your results). Understand why you or other family members have developed cancer.

But it also can have these disadvantages: No guarantee your test results will remain private. Although rare, you may face discrimination. But the Genetic Information Nondiscrimination Act (GINA) of 2008 provides some protection when it comes to health insurance and employment. Find details at http://www.genome.gov/24519851. You may find it harder to cope with your cancer risk when you know your test results. If you find that you dont have an inherited altered gene, you may think that you have no chance of getting cancer. But you can still get cancer.

Sources: National Cancer Institute; National Human Genome Research Institute American Society of Human Genetics: http://www.ashg.org/education/everyone.shtml

Learn more American Society of Human Genetics family history site: http://www.talkhealthhistory.org My Family Health Portrait: https://familyhistory.hhs.gov American Cancer Society: http://www.cancer.org National Cancer Institute: http://www.cancer.gov

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Genetics provide cancer insight

Recommendation and review posted by Bethany Smith

By Sean Williams | More Articles March 20, 2012 |

Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.

What: Shares of molecular diagnostics company Myriad Genetics (Nasdaq: MYGN) dipped 10% earlier in today's trading session following an unfavorable patent ruling for one of the company's peers.

So what: This morning, a U.S. court ruled against Prometheus Laboratories, a unit of Nestle (yes, the maker of those delicious chocolate bars), stating that it could not patent a diagnostic method to observe changes in a patients body to determine the best drug dosage for certain diseases. Since companies like Myriad have similar diagnostic technologies, and these companies rely on patents to protect their technology, this could be a major blow to the sector.

Now what: Ive long been a Myriad bull, and Im not ready to throw in the towel on one specific ruling. But, I have to admit that todays patent rejection doesnt exactly let shareholders sleep easier at night. At 17 times forward earnings, the stock seems fairly valued. Its definitely a company Id add to my watchlist considering the boom in diagnostic medicine expected over the next decade.

Craving more input? Start by adding Myriad Genetics to your free and personalized watchlist so you can keep up on the latest news with the company.

Continued here:
Myriad Genetics Shares Plunged Temporarily: What You Need to Know

Recommendation and review posted by Bethany Smith

20-03-2012 09:38 A new way of delivering gene therapy to the body is developed by OU Medicine. http://www.uhatok.com

See the article here:
Gene Therapy Delivery System - Video

Recommendation and review posted by Bethany Smith

SILVER SPRING, Md.--(BUSINESS WIRE)--

Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions through its acquisition of the SG Austria assets, today discussed the value of encapsulation, freezing, storage, survivability and localization of human stem cells once implanted using the proprietary Cell-in-a-Box technology.

The encapsulation of human stem cells is enabled by the Cell-in-a-Box technology, which can then be frozen, stored and later implanted into target tissues. The benefits of encapsulation are several: first, the process allows for freezing of stem cells for long-term storage without appreciably affecting viability. Second, encapsulation protects the stem cells from stress factors caused by direct aeration and sheer forces associated with bioreactors. Third, Cell-in-a-Box encapsulated stem cells are held in place at the site of implantation, maximizing their potential efficacy as they have the potential to stimulate growth of surrounding new, healthy tissue. Finally, encapsulated cells may prevent any potential side effects associated with direct injection since they remain localized to the area of treatment when encapsulated.

Dr. Robert Ryan, Chief Executive Officer of Nuvilex, commented, For many years it was assumed stem cells existed only to replace cells that had died or were damaged. Recent studies suggest factors stem cells secrete provide signals to surrounding tissue that can stimulate regeneration. The potential therefore, is that if stem cells can be maintained at a particular site where damaged, removed or non-functional tissue was through some sort of holding mechanism, this may aid in a positive growth response in that tissue. In addition, the stem cells themselves have the potential to undergo development into the appropriate cell type at that location, potentially creating miniature organs. The Cell-in-a-Box technology is designed specifically for those purposes. Thus, encapsulated stem cells would be implanted and remain in place, ultimately being able to serve a broad number of medical applications entirely dependent on where in the body they are placed.

About Nuvilex

Nuvilex, Inc. (OTCQB:NVLX) is an emerging international biotechnology provider of live clinically useful, therapeutically valuable, encapsulated cells, as well as services for encapsulating live cells for the research and medical communities. Through substantial effort, the aspects of our corporate activities alone and in concert with SG Austria continue to move toward agreement completion and ultimately a strong future together. Our companys ultimate clinical offerings will include cancer, diabetes and other treatments using the companys industry-leading cell and gene therapy expertise and cutting edge, live-cell encapsulation technology.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 involving risks and uncertainties, including product demand, market competition, and Nuvilexs ability to meet current or future plans which may cause actual results, events, and performances, expressed or implied, to vary and/or differ from those contemplated or predicted. Investors should study and understand all risks before making an investment decision. Readers are recommended not to place undue reliance on forward-looking statements or information. Nuvilex is not obliged to publicly release revisions to any forward-looking statement, to reflect events or circumstances afterward, or to disclose unanticipated occurrences, except as required under applicable laws.

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Cell-in-a-Box® Encapsulation Technology Creates Extensive Applications within the Stem Cell Arena

Recommendation and review posted by Bethany Smith

Dexmedetomidine for Maintaining Sedation

During prolonged mechanical ventilation, sedation with midazolam or propofol is associated with serious adverse effects. Jakob and colleagues assessed the efficacy of dexmedetomidinean 2-agonist sedativecompared with either midazolam or propofol in 2 multicenter randomized trials that involved 998 patients expected to require more than 24 hours' mechanical ventilation. Among the authors' findings was that dexmedetomidine was not inferior to midazolam or propofol in maintaining light to moderate sedation or in reducing total ventilation duration compared with midazolam. However, dexmedetomidine was associated with more adverse events. In an editorial, Wunsch discusses the costs and benefits of sedative options for critically ill patients undergoing mechanical ventilation.

(ARTICLE) (ARTICLE)

Epinephrine is widely used in resuscitation of patients with out-of-hospital cardiac arrest; however, its effectiveness is not established. Hagihara and colleagues analyzed registry data from 417188 patients with out-of-hospital cardiac arrest to assess the relationship between prehospital epinephrine use and mortality and functional status among survivors. The authors report that prehospital epinephrine use was associated with increased return of spontaneous circulation before hospital arrival but decreased the likelihood of survival at 1 month or survival with good functional status. In an editorial, Callaway discusses the evidence that epinephrine use during cardiopulmonary resuscitation may not improve patient-oriented outcomes.

(ARTICLE) (ARTICLE)AND AUTHOR AUDIO INTERVIEW

Immunosuppressive induction therapyroutine in organ transplantsreduces the risk of organ rejection but is associated with adverse effects. Infusion of bone marrowderived mesenchymal stem cells, which have immunoregulatory effects, may offer an alternative immunosuppressive approach. In a randomized trial of 159 patients undergoing living-related kidney transplants, Tan and colleagues found that compared with conventional antiinterleukin 2 receptor antibodybased therapy, a regimen that involved infusion of autologous mesenchymal stem cells was associated with a lower incidence of acute rejection and better renal function at 1 year.

(ARTICLE)

The use of anesthesiologists or nurse anesthetists to administer procedural sedation during outpatient endoscopies increases costs. In a retrospective analysis of claims data from 1.1 million Medicare beneficiaries and 5.5 million commercially insured patients, Liu and colleagues found that utilization of anesthesia services during upper endoscopies and colonoscopies increased from approximately 14% in 2003 to more than 30% in 2009. The majority of anesthesia services were provided to low-risk patients and varied across geographic regions. In an editorial, Fleisher discusses factors that may contribute to increased use of anesthesia services for patients undergoing endoscopy procedures.

(ARTICLE) (ARTICLE)AND AUTHOR VIDEO INTERVIEW

Mrs N, a 75-year-old woman, has a several-year history of hearing loss, which is more bothersome to her family than herself. Pacala and Yueh discuss the prevalence, etiology, and consequences of hearing loss in older patients; its evaluation and treatment, including the selection and fitting of hearing aids; and special challenges to effective hearing aid use among older adults with multiple comorbidities.

Original post:
This Week in JAMA [This Week in JAMA]

Recommendation and review posted by sam

In a unanimous ruling the US Supreme Court has rendered invalid two patents covering a method for determining proper drug dosage. The 20 March decision sent ripples through the medical diagnostics industry, which has been closely following the case.

The patents were held by Prometheus Laboratories, a therapeutics and diagnostics company based in San Diego, California. They covered the process of administering thiopurine drugs which are used to treat autoimmune diseases such as Crohns disease to patients and then measuring the levels of certain metabolites in the blood to determine whether the patient had received a safe and effective dose.

A new landmark for patent law?

Daderot

The defendant in the case, a division of the Mayo Clinic, based in Rochester, Minnesota, initially bought diagnostic tests based on the patents, but in 2004 decided that it wanted to market its its own test, which uses a similar method. Prometheus sued in June of that year, and the case has been working its way through the courts ever since.

The medical-diagnostics industry has been shaken by recent legal challenges to its patents, most notably a high profile case challening the validity of gene patents held by Myriad Genetics, a diagnostics company based in Salt Lake City, Utah (see 'US Court upholds Myriad's breast cancer gene patents'). Critics argue that some of the patents being challenged are based on natural phenomena, which are not patentable unless they have been somehow altered by humans. The Supreme Court agreed, a decision which sent the share prices of some biotechnology companies tumbling; Myriad's stock dropped by more than 5%.

The ruling is also likely to send companies and universities scrambling to determine which of their discoveries are still eligible for patenting, says William Simmons, a patent attorney at the law firm Sughrue Mion in Washington DC. There are going to be areas of technology that are methods for treating individuals that simply cannot be patented as a result of this decision, he says. It has a dramatic impact on the medical community and the scientific research community.

In 2010, the US Court of Appeals for the Federal Circuit sided with Prometheus and upheld the patents, saying that the administration of drugs to patients and the measurement of metabolites in the blood were both steps that transformed a particular article into a different state or thing. But the Supreme Court disagreed. Neither step was transformative, wrote Justice Stephen Breyer, arguing instead that the patents covered a law of nature. Harking back to the archetypal eureka moment of antiquity, Breyer wrote: Nor could Archimedes have secured a patent for his famous principle of flotation by claiming a process consisting of simply telling boat builders to refer to that principle in order to determine whether an object will float.

Such a position is strongly opposed by the biotechnology industry, which has said that overturning the patents could stifle innovation, particularly in the development of personalized medicine. In a statement released after the court issued its decision, Hans Sauer, deputy general counsel for intellectual property at the Biotechnology Industry Organization, a Washington DC-based lobbying group, cautioned against unintended consequences of the decision for patents on biomarker-based diagnostic methods. The Court's opinion fails to appropriately recognize the importance of personalized medicine, he wrote, and of the research and investment incentives needed to develop new individualized therapies for untreated diseases.

In contrast, Breyer argued that upholding rather than striking down the patents risked inhibiting future innovation, a danger that becomes acute when a patented process is no more than a general instruction to 'apply the natural law'.

Excerpt from:
US Supreme Court upends diagnostics patents

Recommendation and review posted by sam

Editor's Choice Academic Journal Main Category: Huntingtons Disease Also Included In: Stem Cell Research Article Date: 19 Mar 2012 - 10:00 PDT

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However, according to a study published March 15 in the journal Cell Stem Cell, a special type of brain cell created from stem cells could help restore the muscle coordination deficits that are responsible for uncontrollable spasms, a characteristic of the disease. The researchers demonstrated that movement in mice with a Huntington's-like condition could be restored.

Su-Chun Zhang, a University of Wisconsin-Madison neuroscientist and the senior author of the study, said:

In the study Zhang, who is an expert in creating various types of brain cells from human embryonic or induce pluripotent stem cells, and his team focused on GABA neurons. The degradation of GABA cells causes the breakdown of a vital neural circuit and loss of motor function in individuals suffering from Huntington's disease.

According to Zhang, GABA neurons generate a vital neurotransmitter, a chemical that helps support the communication network in the brain that coordinates movement.

Zhang and his team at the UW-Madison Waisman Center, discovered how to generate large quantities of GABA neurons from human embryonic stem cells. The team's goal was to determine whether these cells would safely integrate into the brain of a mouse model of Huntington's disease.

Read more here:
Huntington's Disease - Stem Cell Therapy Potential

Recommendation and review posted by simmons

MOUNTAIN VIEW, Calif., March 20, 2012 /PRNewswire/ -- SanBio Inc. today announced the successful enrollment of the first dose cohort of patients in its Phase 1/2a clinical trial testing the safety and efficacy of a novel allogeneic stem cell therapy product, SB623, in patients suffering from chronic deficits resulting from previous stroke injuries. The first 6 patients, of a total of 18, have been successfully administered SB623. The trial is being conducted at Stanford University and the University of Pittsburgh. No safety concerns have been reported. For details regarding this clinical trial, please refer to http://www.strokeclinicaltrial.org.

SB623 is derived from adult bone marrow and has shown safety and efficacy in rodent models of chronic stroke. "This represents a major milestone in the human clinical testing of this important new approach for regenerative medicine", said Keita Mori, SanBio CEO. "We are pleased to learn that the initial dose level was well tolerated."

SB623 is being delivered to the damaged region of the brains of patients who have suffered an ischemic stroke. Product safety is the primary focus of the study but various measurements of efficacy are also being tested.

"The successful completion of the initial dose cohort is a major step in any first-in-human study", said Dr. Ernest Yankee, SanBio's Vice President of Development. "We are looking forward to initiating the next two dose cohorts and wrapping up the study. The safety findings thus far are very encouraging"

About SB623: SB623 is a proprietary cell therapy product consisting of cells derived from genetically engineered bone marrow stromal cells obtained from healthy adult donors. SB623 is administered adjacent to the area damaged by stroke and functions by producing proteins that aid the regenerative process.

About SanBio: SanBio is a privately held San Francisco Bay Area biotechnology company focused on the discovery and development of new regenerative cell therapy products.

For more information: http://www.san-bio.com

Continued here:
SanBio Announces Enrollment of First Cohort of Patients in Its Clinical Trial of Stem Cell Therapy for Chronic Stroke

Recommendation and review posted by simmons

A special dog used to help people is getting some much-needed help of her own at a Virginia clinic, myFOXdc.com reported.

Red, a 12-year-old black Labrador, is one of the last surviving search and rescue dogs deployed during the 9/11 attacks.

Her handler, Heather Roche, told WTTG-TV that Red was recently certified when Sept. 11, 2001, occurred, and the devastating terror attacks were her first big mission.

Red's job was to find DNA evidence at The Pentagon's north parking lot with 26 other dogs, and according to Roche, she did a "fantastic job."

"I got her as a puppy ... You have to convince [her] everything that she does, whether it's climbing ladders or any kind of search, that it's her idea," Roche told WTTG-TV. "No matter what I've asked her to do, she's done it and she's done it flawlessly."

But in her old age Red developed crippling arthritis, and underwent stem cell regenerative therapy Monday to help ease her pain so she can get back out on the job.

Dr. John Herrity of Burke Animal Clinic in Burke, Va., told WTTG-TV, "Red has a back issue that, after a fall from a ladder has not really been right, and has been living in pain, so we're going to give those stem cells IV [intravenously] and then also inject them along the back to try to help Red's comfort."

"She's had a great career and has made a difference to a lot of families by bringing their loved ones home," Roche said.

Click here to read more.

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9/11 search and rescue dog receives stem cell therapy

Recommendation and review posted by simmons

GOLDEN, Colo., March 20, 2012 (GLOBE NEWSWIRE) -- Vitro Diagnostics, Inc. (OTCQB:VODG.PK - News), dba Vitro Biopharma, has recently received approval for its presentation entitled "GMP Cell Culture Media for Expansion of MSCS Prior to Allogeneic or Autologous Transplantation." The Company recently expanded its stem cell media products to include clinical grade MSC-Gro(TM) media for use in clinical trials of stem cells. The Company will present its current findings at the annual meeting of the International Society of Cellular Therapy (ISCT) in Seattle, Washington this coming June. To get more information regarding the International Society of Cellular Therapy visit http://www.celltherapysociety.org/

Vitro Biopharma has developed a series of products to support clinical application of adult stem cells known as mesenchymal stem cells (MSCs) that are completely divorced and different from ethically contentious embryonic stem cells. MSCs are derived from numerous adult tissue sources including bone marrow, blood, adipose tissue, teeth, etc and show considerable promise in clinical applications especially for treatment of injury and diseases affecting joints, bone, ligaments and tendons. There are over 200 ongoing clinical trials of MSCs to study potential treatment of diabetes, Parkinson's disease, organ transplant rejection, osteoarthritis, MS, spinal cord injury, stroke, myocardial infarction, cardiovascular disease, liver degeneration, COPD and other medical conditions.

Vitro Biopharma will present the current status of its clinical grade MSC-Gro(TM) Brand of culture medium for growth and differentiation of MSCs at the ISCT meeting. Through its extensive research and experience with cell culture media, Vitro Biopharma has developed highly competitive media that is suitable for clinical applications. Critical characteristics are that they are serum-free, chemically-defined and free from animal-derived components. Furthermore, it is essential that serum-free media perform the same as formulations containing contain blood serum, a complex mixture of biologically active components with intrinsic variability from batch to batch and safety issues regarding potential infectious agents. Vitro will present its results regarding each of these points and the status of FDA approval of its clinical products.

Dr. Jim Musick, Vitro's President & CEO, said, "We are very pleased to be approved for presentation at the ISCT Annual Meeting. It is apparent from the reported widespread efficacy of MSCs in clinical trials and the low incidence of adverse effects that there is potential to achieve regulatory approval for advanced treatment of many diseases, injuries and cellular degenerative conditions. Our new clinical products expand our offering of tools to support stem cell research by providing highly competitive new products for clinical studies including our serum-free, animal-free and chemically defined MSC-Gro(TM) Brand of media formulations optimized for human MSC self-renewal & lineage-specific differentiation, together with LUMENESC(TM) high performance assays of stem cell quality, potency and response to toxic agents. We intend to leverage our current advances in human medical MSC-based treatments to offer products for treatment of horses, dogs and cats. The results of MSC therapy in animals may also provide safety and efficacy data to support human clinical studies."

About Vitro Diagnostics, Inc.

Vitro Diagnostics, Inc. dba Vitro Biopharma (OTCQB:VODG.PK - News) (http://www.vitrobiopharma.com), owns US patents for production of FSH, immortalization of pituitary cells, and a cell line that produces beta islets for use in treatment of diabetes. Vitro also owns a pending international patent for generation of pluripotent stem cells. Vitro's mission is "Harnessing the Power of Cells(TM)" for the advancement of regenerative medicine to its full potential. Vitro operates within a modern biotechnology manufacturing, R&D and corporate facility in Golden, Colorado. Vitro manufactures and sells "Tools for Stem Cell and Drug Development(TM)", including human mesenchymal stem cells and derivatives, MSC-Gro(TM) optimized media for stem cell self-renewal and lineage-specific differentiation. Vitro recently formed a strategic alliance with HemoGenix(R), Inc. (http://www.hemogenix.com/) to jointly manufacture and distribute LUMENESC(TM) and LumiSTEM(TM) quantitative assays for determination of stem cell quality, potency and response to toxic agents.

The Vitro Biopharma logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=12086

Safe Harbor Statement

Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward looking statements are identified by words such as "intends," "anticipates," "believes," "expects" and "hopes" and include, without limitation, statements regarding the Company's plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company's products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company's filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward looking statements, whether as a result of new information, future events or otherwise.

Continued here:
Vitro Biopharma Receives Approval for Presentation to the International Society for Cellular Therapy

Recommendation and review posted by simmons

NEW YORK, March 20, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE Amex:NBS) ("NeoStem" or "the Company") is a leader in the cell therapy industry, developing cell based therapeutics supported by the Company's expertise in contract manufacturing. This strategic combination and depth of experience in cell therapy development and manufacturing provide NeoStem with unique capabilities to develop its own cell therapies and that sets the Company apart from others in the cell therapy landscape. 2011 represented a major year of strategic transition for NeoStem, and the Company plans to build upon that in 2012 and in the years ahead.

NeoStem reported its audited results for 2011. Consolidated revenues for the year ended December 31, 2011 were $73.7 million compared to $69.8 million for 2010. The Company's consolidated net loss for 2011 was $56.6 million, which included $10.3 million of non-cash equity-based compensation expense, $19.4 million of goodwill impairment charges and $9.0 million of depreciation and amortization. Overall, the Company's consolidated cash loss for 2011 was $15.5 million (see reconciliation below). Net loss attributable to NeoStem common shareholder interests for 2011 was $47.8 million, or $0.54 per share.

As of December 31, 2011, the Company had consolidated cash and cash equivalents of $12.7 million, and an additional $2.5 million in cash held in escrow (classified in Other Assets).

NeoStem believes that the opportunities that exist today in cell therapy are robust and growing despite a persistently difficult financial environment, making this an opportunistic time to pursue the monetization of the Company's 51% ownership of Suzhou Erye Pharmaceutical Co., Ltd. and bolster its cell therapy business. In June 2011, the Company engaged a financial advisor to lead the effort to pursue the possible divestiture of the Company's interest in Erye. Marketing efforts are underway and have generated interest from both financial and strategic buyers.

On the therapeutics side of the business NeoStem now has a pipeline of assets that includes Amorcyte (Phase 2 trial for preservation of heart function after a heart attack), Athelos (physician sponsored Phase 1 trials for a range of auto-immune conditions) and pre-clinical development work on its VSEL(TM) technology. The Company's most advanced asset is AMR-001 for the treatment of acute myocardial infarction for which enrollment for a Phase 2 study in the United States commenced in January. The study is a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of infarct-related artery infusion of AMR-001, an autologous bone marrow derived cell therapy enriched for CD34+ cells. AMR-001 is administered 5 to 11 days post-stent placement in patients diagnosed with an ST segment elevation myocardial infarction ("STEMI") with ejection fraction less than or equal to 48%. The study will include 160 subjects, age 18 and older, randomized 1:1 between treatment and control. The manufacturing, product supply, and logistics for the trial will be supported by Progenitor Cell Therapy, LLC, NeoStem's contract manufacturing company.

Amorcyte currently has ten activated clinical trial sites for its Phase 2 AMI clinical trial with the initial patients enrolled. Trial enrollment is expected to be completed in approximately one year with data read out six months following the last treated patient. The Amorcyte franchise is supported by a strong patent portfolio which includes both composition of matter and methods of treatment around use of these hematopoietic stem cells for treatment of cardiac ischemia and other ischemic tissue that result from vascular insufficiency. The Company sees Amorcyte as a pipeline of therapeutics with potential in multiple indications from STEMI to congestive heart failure and other related vascular insufficiencies. The Amorcyte product addresses both an unmet medical need and a large potential market.

"One of the most important attributes of AMR-001 is that it's 'natural.' We are enhancing the body's normal and natural response to ischemic injury," said Dr. Robin Smith, CEO of NeoStem. "Ample historical evidence, published literature and our own compelling Phase 1 data give us confidence that this product will ultimately make it to the marketplace. Our next most advanced asset is held by Athelos Corporation, (a NeoStem company, partnered with Becton, Dickinson and Company) which is developing a novel T-cell platform for immunological disorders. The Athelos T-cell technology represents an innovative approach to restoring immune balance with potential applications in graft vs. host disease (GvHD), solid organ transplant (SOT) and autoimmune diseases, such as asthma and diabetes. Multiple physician sponsored phase 1 studies are expected to report results that will be used to determine the direction of clinical development.

"NeoStem is also developing pre-clinical assets, including its VSEL(TM) Technology platform for regenerative medicine, which NeoStem believes is an endogenous pluripotent non-embryonic cell that has the potential to change the paradigm of cell therapy as we know it today. These activities have received awards in excess of $2.5 million which funds support the work of prestigious researchers who are pioneering this science with NeoStem.

"Behind the development of these therapeutic assets is the NeoStem cell therapy contract manufacturing business (PCT) which itself continues to grow. New clients have engaged PCT to assist them in the development of their products, including a global, diversified healthcare company who recently selected PCT to provide stem cell processing in our two GMP manufacturing facilities in the United States (California and New Jersey). PCT's prominence in the marketplace continues to grow and that is reflected by both client satisfaction and the revenues the company generates.

"As we look to the year ahead, we are excited on multiple fronts. Our capital preservation efforts are now bearing fruit as our cash burn rate is in-line with our peers. We expect to continue to carefully invest our capital in projects that meet our internal rate of return hurdle and risk parameters. We believe the PCT and Amorcyte acquisitions have created true value for our shareholders and we look forward to demonstrating that as these assets reach their respective value inflection points. We see the unmet medical need in cardiology and the treatment burden associated with chronic diseases as representing a significant challenge to modern society. We believe that cell therapy holds many of the solutions to the health crisis that societies face and have the potential to create real pharmacoeconomic benefit as well as shareholder value for our company.

See the original post here:
NeoStem Provides Updates and Reports Year End Results

Recommendation and review posted by simmons

SILVER SPRING, Md.--(BUSINESS WIRE)--

Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions through its acquisition of the SG Austria assets, today discussed the value of encapsulation, freezing, storage, survivability and localization of human stem cells once implanted using the proprietary Cell-in-a-Box technology.

The encapsulation of human stem cells is enabled by the Cell-in-a-Box technology, which can then be frozen, stored and later implanted into target tissues. The benefits of encapsulation are several: first, the process allows for freezing of stem cells for long-term storage without appreciably affecting viability. Second, encapsulation protects the stem cells from stress factors caused by direct aeration and sheer forces associated with bioreactors. Third, Cell-in-a-Box encapsulated stem cells are held in place at the site of implantation, maximizing their potential efficacy as they have the potential to stimulate growth of surrounding new, healthy tissue. Finally, encapsulated cells may prevent any potential side effects associated with direct injection since they remain localized to the area of treatment when encapsulated.

Dr. Robert Ryan, Chief Executive Officer of Nuvilex, commented, For many years it was assumed stem cells existed only to replace cells that had died or were damaged. Recent studies suggest factors stem cells secrete provide signals to surrounding tissue that can stimulate regeneration. The potential therefore, is that if stem cells can be maintained at a particular site where damaged, removed or non-functional tissue was through some sort of holding mechanism, this may aid in a positive growth response in that tissue. In addition, the stem cells themselves have the potential to undergo development into the appropriate cell type at that location, potentially creating miniature organs. The Cell-in-a-Box technology is designed specifically for those purposes. Thus, encapsulated stem cells would be implanted and remain in place, ultimately being able to serve a broad number of medical applications entirely dependent on where in the body they are placed.

About Nuvilex

Nuvilex, Inc. (OTCQB:NVLX) is an emerging international biotechnology provider of live clinically useful, therapeutically valuable, encapsulated cells, as well as services for encapsulating live cells for the research and medical communities. Through substantial effort, the aspects of our corporate activities alone and in concert with SG Austria continue to move toward agreement completion and ultimately a strong future together. Our companys ultimate clinical offerings will include cancer, diabetes and other treatments using the companys industry-leading cell and gene therapy expertise and cutting edge, live-cell encapsulation technology.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 involving risks and uncertainties, including product demand, market competition, and Nuvilexs ability to meet current or future plans which may cause actual results, events, and performances, expressed or implied, to vary and/or differ from those contemplated or predicted. Investors should study and understand all risks before making an investment decision. Readers are recommended not to place undue reliance on forward-looking statements or information. Nuvilex is not obliged to publicly release revisions to any forward-looking statement, to reflect events or circumstances afterward, or to disclose unanticipated occurrences, except as required under applicable laws.

Here is the original post:
Cell-in-a-Box® Encapsulation Technology Creates Extensive Applications within the Stem Cell Arena

Recommendation and review posted by simmons

Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR) today announced that its PLacental eXpanded (PLX) cells improve several parameters in acute myocardial infarction (heart attacks) in animals. The preclinical trial was conducted at the Center for Regenerative Therapies in Germany.

The trial included 20 mice, which were given induced heart attacks. Half the mice were then given either PLX cells, and the other half were given a cell-free medium as a control. Five other mice underwent a sham (placebo) operation. After four weeks, the mice underwent an ECG, and were then killed for a physical examination of their hearts. The mice which received PLX had improved cardiac muscle function compared with the control group.

Study leader Prof. Christof Stamm said, "As a cardiac surgeon, the unique ability demonstrated by Pluristem's PLX cells for the treatment of heart disease is very exciting." He added, "PLX cells showed promising results in the AMI studies."

Pluristem chairman and CEO Zami Aberman said, "These results demonstrate the potential benefits of our cells for use in the treatment of ischemic heart disease, a multi-billion dollar annual market, and one in which many pharmaceutical companies are constantly looking to provide patients with innovative and effective solutions. In addition to moving ahead with our AMI trial, we look forward to continuing to work on finding cell therapy solutions for numerous debilitating diseases."

An article in the New England Journal of Medicine states that 624,000 patients suffer an acute myocardial infarction annually in the US, a number that will most likely increase with the rising prevalence of obesity, diabetes and the aging of the population.

Pluristem's share price rose 5.1% by mid-afternoon on the TASE today to NIS 8.50, after closing at $2.15 on Nasdaq yesterday, giving a market cap of $95 million. The share is up 6.5% in premarket trading on Nasdaq today.

Published by Globes [online], Israel business news - http://www.globes-online.com - on March 20, 2012

Copyright of Globes Publisher Itonut (1983) Ltd. 2012

Continue reading here:
Pluristem reports success in stem cell heart attack treatment

Recommendation and review posted by sam

Public release date: 19-Mar-2012 [ | E-mail | Share ]

Contact: Julia Evangelou Strait straitj@wustl.edu 314-286-0141 Washington University School of Medicine

Doctors at Washington University School of Medicine in St. Louis have shown that a new drug makes chemotherapy more effective in treating acute myeloid leukemia, a cancer of the white blood cells. Instead of attacking these cells directly, the drug helps drive them out of the bone marrow and into the bloodstream, where they are more vulnerable to chemotherapy.

"We're usually very good at clearing these leukemia cells from the blood," says Geoffrey L. Uy, MD, assistant professor of medicine and co-first author on the study published in the journal Blood. "But it's much harder to clear these cancerous cells from the bone marrow."

This combined phase 1 and 2 clinical trial included 52 patients with acute myeloid leukemia (AML) who had relapsed or whose AML was resistant to the standard chemotherapy regimen. In the phase 2 portion with 46 patients, all received the investigational drug, and 46 percent achieved complete remission, meaning no evidence of cancer could be found in the blood or bone marrow after treatment.

"In general, we see complete remission rates between 20 and 30 percent," says Uy, who treats patients at the Alivn J. Siteman Cancer Center at Washington University School of Medicine and Barnes-Jewish Hospital. "But a lot depends on individual patient characteristics."

Indeed, recent genetic studies have shown that mutations leading to AML may differ greatly among patients. But regardless of individual mutations, all of these leukemia cells rely in some way on the protective effects of the bone marrow, according to senior author John F. DiPersio, MD, PhD, the Virginia E. and Sam J. Golman Professor of Medicine.

"With DNA sequencing identifying so many mutations that are unique to one patient, it may be very hard to find therapies that work directly on the cancer," says DiPersio, who also treats patients at the Siteman Cancer Center. "Instead, we are targeting a common pathway that all leukemic cells are addicted to in this case, the relatively normal environment of the bone marrow."

DiPersio calls the results of this study encouraging and worthy of additional exploration.

"If these results are repeated in a larger study, it would be transformative," he says. "It would change the standard way we treat these patients we would use this approach with everybody. In addition, the approach of targeting the tumor microenvironment could also be exploited for the treatment of other hematologic and solid tumor malignancies."

See the rest here:
Drug makes leukemia more vulnerable to chemo

Recommendation and review posted by sam

Four-year-old Angela Irizarry was born with a single pumping chamber in her heart, a potentially lethal defect. To fix the problem, Angela is growing a new blood vessel in her body in an experimental treatment that could advance the burgeoning field of regenerative medicine.

Doctors at Yale University here implanted in Angela's chest in August a bioabsorbable tube that is designed to dissolve over time. The tube was seeded with cells, including stem cells, that had been harvested from Angela's bone marrow. Since then, the doctors say, the tube has disappeared, leaving in its place a conduit produced by Angela's cells that functions like a normal blood vessel.

"We're making a blood vessel where there wasn't one," said Dr. Christopher Breuer, the Yale pediatric surgeon who led the 12-hour procedure to implant the device. "We're inducing regeneration."

Angela, who had little stamina before the operation, now has the energy of a regular kid. She is on several medications, but Breuer and her parents think she'll be able to start school in the fall.

Scientists have long been captivated by the ability of animals such as salamanders and starfish to regrow body parts lost to injury. It was long assumed that developmental forces that create a human being in the womb are lost at birth. But recent advances in stem-cell research and tissue engineering suggest that regenerative forces can be reawakened with strategically implanted stem cells and other tissue.

This notion is fueling research at many academic laboratories and dozens of start-up companies where scientists are hoping to identify effective ways to treat maladies including heart muscle damaged from heart attacks, paralysis due to spinal cord injuries and poor-functioning kidneys and bladders.

Angela's condition, known as hypoplastic left heart syndrome, affects some 3,000 newborns in the U.S. each year. With just one pumping chamber, or ventricle, instead of the usual two, the babies can't deliver sufficient levels of oxygen to their organs and extremities, compromising their development and causing them to turn blue and suffer from a lack of energy. Without a surgical repair, says Breuer, 70 percent of them die before their first birthday.

Pediatric surgeons typically treat the condition with a series of operations called the Fontan procedure, designed to enable the heart to function without the missing ventricle. The last operation involves implanting a synthetic blood vessel made of Gore-Tex to reroute blood from the lower extremities directly to the lungs instead of through the heart. The device works, but it is prone to clotting, infection and in some cases, the need for additional surgery later in life as the child grows. The idea behind Breuer's project is that a natural conduit with the biology of a normal blood vessel would grow with the child and avoid or significantly reduce complications associated with a synthetic tube.

Angela's case "is a real milestone and broadly important for the field of tissue engineering," said Robert Langer, a researcher at Massachusetts Institute of Technology and a regenerative-medicine pioneer who isn't involved in the Yale initiative. "It gives you hope that when you combine cells with a scaffold and [put] them in the body, they will do the right thing."

Angela's heart defect was diagnosed in utero, when her mother Claudia was five months pregnant. She had her first operation when she was 5 days old, and another at 8 months. But her heart defect was taking a toll. She was shy, small for her age and lacked the stamina of a normal 3-year-old.

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To fix a heart, doctors train girl's body to grow new part

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CARLSBAD, Calif.--(BUSINESS WIRE)--

International Stem Cell Corporation (OTCBB: ISCO.OB - News) (www.internationalstemcell.com) today announced year-end financial results for the year ended December 31, 2011. ISCO is a California-based development-stage biotechnology company that is focused on therapeutic, biomedical and cosmeceutical product development and commercialization with multiple long-term therapeutic opportunities and two revenue-generating businesses offering potential for increased future revenue.

ISCO reported revenue of $1.1 million for the fourth quarter ended December 31, 2011, reflecting a 110% increase from the same period of the prior year. For the twelve months ended December 31, 2011, the Company reported revenue of $4.5 million, reflecting a year-over-year increase of 189%. The increases in revenues in both periods were primarily driven by strong sales at ISCOs wholly-owned subsidiary Lifeline Skin Care (LSC). In addition, steady growth in sales from ISCOs other wholly-owned subsidiary, Lifeline Cell Technology (LCT), contributed to the increases in revenues for both periods.

While the Company continued to invest in therapeutic projects, development of new technologies, and expansion of products and channels of distribution, to date we have generated limited revenue to support our core therapeutic research and development efforts. For the three months ended December 31, 2011, development expenses, excluding cost of sales, increased $507,000 or 17% compared with the same period of 2010, a reflection of increased G&A expenses resulting from higher stock-based compensation expenses.

For the twelve months ended December 31, 2011, development expenses, excluding costs of sales, increased approximately $3.0 million or 26% when compared with the prior year period.The majority of the increase was primarily due to increases in general and administrative and research and development activities. General and administrative expenses increased largely due to increased non-cash stock-based compensation, higher headcount, and increased expenses related business development activity and general corporate expenses. Research & Development expenses increased mainly due to increased number and complexity of experiments associated with our scientific projects. The increase in development expenses was also related to increased research activities on therapeutic products and product research activities for LSC and LCT coupled with increased sales and marketing expenses related to our skin care products.

Some of the 2011 Highlights:

-- A number of donors willing to provide oocytes for research purposed were enrolled in ISCO's program to establish a bank of clinical grade hpSC capable of being immune-matched to millions of patients.

-- The Research and Development team successfully completed the first series of preclinical studies that supports the therapeutic use of hepatocytes (liver cells) and neuronal cells derived from human parthenogenetic stem cells (hpSC). These in vivo experiments demonstrated that the derived cells are able to survive in targeted locations in mice without causing tumors.

-- We became Sarbanes-Oxley compliant and maintained, in all material respects, effective internal controls over financial reporting as of December 31, 2011.

-- We strengthened our Management Team through the appointments of well-known industry executives: Kurt May as President & Chief Operating Officer, Linh Nguyen as Chief Financial Officer, Donna Queen as Vice President of Marketing and Business Development for LSC.

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International Stem Cell Corporation Announces 2011 Financial Results

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