BioLineRx to Initiate Phase ‘ Study with BL-84 as Novel Stem Cell Mobilization Treatment Following Successful … – GuruFocus.com
Posted: May 3, 2017 at 4:46 pm
TEL AVIV, Israel, May 3, 2017 /PRNewswire/ --
- Initiation of Phase 3 registrational study expected in second half of this year
- Study to focus on stem cell mobilization for autologous transplantation in multiple myeloma patients
BioLineRx Ltd. (NASDAQ/TASE: BLRX, BLRX.TA), a clinical-stage biopharmaceutical company focused on oncology and immunology, today announced that it has met with the U.S. Food and Drug Administration (FDA) and has gained clarity on the development program and the design of a Phase 3 pivotal study for BL-8040, its robust platform for multiple oncology indications, as a novel stem cell mobilization treatment for autologous bone-marrow transplantation. Following its successful meeting with the FDA, the Company anticipates the initiation of a registrational Phase 3 trial during the second half of 2017. The study will investigate BL-8040 in combination with granulocyte colony-stimulating factor (G-CSF) for mobilization of stem cells from the bone marrow to the peripheral blood, followed by collection and subsequent autologous transplantation in patients with multiple myeloma.
"BL-8040 given as a single injection in a Phase 1/2 study in multiple myeloma patients was previously shown to be highly effective in mobilizing stem cells in combination with G-CSF," said Philip Serlin, Chief Executive Officer of BioLineRx. "Following our recent successful meeting with the FDA, we believe we have a clear development path forward towards registration of BL-8040 as a novel stem cell mobilization treatment for autologous transplantation. We look forward to the initiation of the Phase 3 pivotal study later this year, which, if successful, could pave the way for future commercialization of BL-8040."
"We see clear potential for BL-8040 to benefit multiple myeloma patients undergoing autologous bone marrow transplantation. In parallel, we are continuing to expand the potential of our unique BL-8040 oncology platform, with multiple clinical studies for additional indications that are up and running or expected to commence during 2017. These include several combination studies with immune checkpoint inhibitors, a Phase 2b study in consolidation AML and a Phase 2 study in allogeneic stem-cell mobilization as a monotherapy with topline results expected by the end of 2017," added Mr. Serlin.
About BL-8040
BL-8040 is a short peptide for the treatment of acute myeloid leukemia, solid tumors, and stem cell mobilization. It functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of cancer cells from the bone marrow, thereby sensitizing these cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing apoptosis. In addition, BL-8040 has also demonstrated robust stem-cell mobilization, including the mobilization of colony-forming cells, and T, B and NK cells. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.
About Stem Cell Mobilization
High-dose chemotherapy followed by stem cell transplantation has become an established treatment modality for a variety of hematologic malignancies, including multiple myeloma, as well as various forms of lymphoma and leukemia. Stem cells are mobilized from the bone marrow using granulocyte colony-stimulating factor (G-CSF), harvested from the peripheral blood by apheresis, and infused to the patient after chemotherapy. This type of treatment often replaces the use of traditional bone marrow transplantation, because the stem cells are easier to collect and the treatment allows for a quicker recovery time and fewer complications.
About BioLineRx
BioLineRx is a clinical-stage biopharmaceutical company focused on oncology and immunology. The Company in-licenses novel compounds, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization.
BioLineRx's leading therapeutic candidates are: BL-8040, a cancer therapy platform, which has successfully completed a Phase 2a study for relapsed/refractory acute myeloid leukemia (AML) and is in the midst of a Phase 2b study as an AML consolidation treatment and a Phase 2 study in stem cell mobilization for allogeneic transplantation; and AGI-134, an immunotherapy treatment in development for multiple solid tumors, which is expected to initiate a first-in-man study in the first half of 2018. In addition, BioLineRx has a strategic collaboration with Novartis Pharma AG for the co-development of selected Israeli-sourced novel drug candidates; a collaboration agreement with MSD (known as Merck in the US and Canada), on the basis of which the Company has initiated a Phase 2a study in pancreatic cancer using the combination of BL-8040 and Merck's KEYTRUDA; and a collaboration agreement with Genentech Inc., a member of the Roche Group, to investigate the combination of BL-8040 and Genentech's Atezolizumab in several Phase 1b studies for multiple solid tumor indications and AML.
For additional information on BioLineRx, please visit the Company's website at http://www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events. BioLineRx industry updates are also regularly updated on Facebook, Twitter, and LinkedIn.
Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Some of these risks are: changes in relationships with collaborators; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 23, 2017. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.
Contacts: PCG Advisory Vivian Cervantes Investor Relations +1-212-554-5482 [emailprotected]
or
Tsipi Haitovsky Public Relations +972-52-989892 [emailprotected]
SOURCE BioLineRx Ltd.
View original post here:
BioLineRx to Initiate Phase ' Study with BL-84 as Novel Stem Cell Mobilization Treatment Following Successful ... - GuruFocus.com
- Bone Marrow Stem Cells [Last Updated On: June 24th, 2011] [Originally Added On: June 24th, 2011]
- Stem cells in bone marrow are being used to treat EB [Last Updated On: June 24th, 2011] [Originally Added On: June 24th, 2011]
- Stem cells in bone marrow are being used to treat EB [Last Updated On: June 25th, 2011] [Originally Added On: June 25th, 2011]
- Peripheral Artery Disease: Can Progenitor Cells Help? [Last Updated On: June 25th, 2011] [Originally Added On: June 25th, 2011]
- Bone Marrow Producing Insulin [Last Updated On: June 25th, 2011] [Originally Added On: June 25th, 2011]
- Stem Cells Reversing Endothelial Senescence [Last Updated On: June 25th, 2011] [Originally Added On: June 25th, 2011]
- Peripheral Artery Disease: Can Progenitor Cells Help? [Last Updated On: June 26th, 2011] [Originally Added On: June 26th, 2011]
- Science behind Enhancing Adult Stem Cells for wellbeing [Last Updated On: June 26th, 2011] [Originally Added On: June 26th, 2011]
- Bone Marrow Stem Cell Applications [Last Updated On: June 26th, 2011] [Originally Added On: June 26th, 2011]
- Immune Modulation by Bone Marrow Mesenchymal Stem Cells [Last Updated On: June 26th, 2011] [Originally Added On: June 26th, 2011]
- Expansion of Stem Cells by Valproic Acid [Last Updated On: June 27th, 2011] [Originally Added On: June 27th, 2011]
- STEM CELLS FOR MACULAR DEGENERATION Sam Smith's story.wmv [Last Updated On: June 27th, 2011] [Originally Added On: June 27th, 2011]
- StemLife's First Cord Blood Stem Cell Transplant Recipient [Last Updated On: June 28th, 2011] [Originally Added On: June 28th, 2011]
- Bone Marrow Differentiation to Heart? YES [Last Updated On: June 28th, 2011] [Originally Added On: June 28th, 2011]
- STEM CELLS FOR OTHER USES Interview with Sam Smith.wmv [Last Updated On: June 29th, 2011] [Originally Added On: June 29th, 2011]
- StemLife's First Cord Blood Stem Cell Transplant Recipient [Last Updated On: June 30th, 2011] [Originally Added On: June 30th, 2011]
- Bone marrow transplantation HD, ENG subtitles [Last Updated On: July 3rd, 2011] [Originally Added On: July 3rd, 2011]
- Cord Blood and Bone Marrow Stem Cells for Liver Failure [Last Updated On: July 4th, 2011] [Originally Added On: July 4th, 2011]
- Bone Marrow Stem Cell Applications [Last Updated On: July 4th, 2011] [Originally Added On: July 4th, 2011]
- Bone Marrow Producing Insulin [Last Updated On: July 5th, 2011] [Originally Added On: July 5th, 2011]
- Bone Marrow Stem Cell Donation [Last Updated On: July 6th, 2011] [Originally Added On: July 6th, 2011]
- Adult Stem Cells May Target and Repair Heart Attack Damage [Last Updated On: July 6th, 2011] [Originally Added On: July 6th, 2011]
- Stem cells used for medical treatment [Last Updated On: July 7th, 2011] [Originally Added On: July 7th, 2011]
- Bone marrow transplantation HD, ENG subtitles [Last Updated On: July 8th, 2011] [Originally Added On: July 8th, 2011]
- Adult Stem Cells May Target and Repair Heart Attack Damage [Last Updated On: July 8th, 2011] [Originally Added On: July 8th, 2011]
- From Surgical Repair to Stem Cell Repair: A Surgeon's Journey by Leonard Smith MD, FACS [Last Updated On: July 13th, 2011] [Originally Added On: July 13th, 2011]
- STEM CELLS - Bone Marrow Stem Cells (Balzitt).flv [Last Updated On: July 14th, 2011] [Originally Added On: July 14th, 2011]
- Spirulina DLA Naturals [Last Updated On: July 15th, 2011] [Originally Added On: July 15th, 2011]
- Spirulina DLA Naturals [Last Updated On: July 16th, 2011] [Originally Added On: July 16th, 2011]
- Insidermedicine In 60 - January 6, 2011 [Last Updated On: July 16th, 2011] [Originally Added On: July 16th, 2011]
- Christian Drapeau Talk About - Adult Stem Cells and StemEnhance./StemTech [Last Updated On: July 18th, 2011] [Originally Added On: July 18th, 2011]
- The potential of stem cells [Last Updated On: July 18th, 2011] [Originally Added On: July 18th, 2011]
- Insidermedicine In 60 - March 11, 2011 [Last Updated On: July 20th, 2011] [Originally Added On: July 20th, 2011]
- Blind Girl get's cure you need to see to believe" [Last Updated On: July 23rd, 2011] [Originally Added On: July 23rd, 2011]
- STEM CELLS - Bone Marrow Stem Cells (Balzitt).flv [Last Updated On: July 23rd, 2011] [Originally Added On: July 23rd, 2011]
- Expansion of Stem Cells by Valproic Acid [Last Updated On: July 23rd, 2011] [Originally Added On: July 23rd, 2011]
- Blind Girl get's cure you need to see to believe" [Last Updated On: July 24th, 2011] [Originally Added On: July 24th, 2011]
- LifeCell in Kalaignar Seithigal,Sun News [Last Updated On: July 26th, 2011] [Originally Added On: July 26th, 2011]
- Science behind Enhancing Adult Stem Cells for wellbeing [Last Updated On: July 27th, 2011] [Originally Added On: July 27th, 2011]
- Why treatment results vary after stem cell treatment [Last Updated On: July 27th, 2011] [Originally Added On: July 27th, 2011]
- From Surgical Repair to Stem Cell Repair: A Surgeon's Journey by Leonard Smith MD, FACS [Last Updated On: August 3rd, 2011] [Originally Added On: August 3rd, 2011]
- Insidermedicine In 60 - March 11, 2011 [Last Updated On: August 4th, 2011] [Originally Added On: August 4th, 2011]
- Why STEM-Enhance? [Last Updated On: August 10th, 2011] [Originally Added On: August 10th, 2011]
- Stem cells Transplatation in Completed Paralyze Dog. [Last Updated On: August 12th, 2011] [Originally Added On: August 12th, 2011]
- Stem cells Transplatation in Completed Paralyze Dog. [Last Updated On: August 15th, 2011] [Originally Added On: August 15th, 2011]
- Best natural skin care serum using stem cell technology [Last Updated On: August 19th, 2011] [Originally Added On: August 19th, 2011]
- "Bone Marrow Stem Cells" Donald Kohn [Last Updated On: August 29th, 2011] [Originally Added On: August 29th, 2011]
- The potential of stem cells [Last Updated On: August 31st, 2011] [Originally Added On: August 31st, 2011]
- Manatee man is paralyzed, but still plenty hopeful [Last Updated On: September 4th, 2011] [Originally Added On: September 4th, 2011]
- Stem Cells and Bone Marrow Transplants by Dipnarine Maharaj MD PhD [Last Updated On: September 5th, 2011] [Originally Added On: September 5th, 2011]
- MS Cure - Introduction to stem cell bone marrow transplant in Australia [Last Updated On: September 5th, 2011] [Originally Added On: September 5th, 2011]
- Bone Marrow/Stem Cell Transplantation: An Introduction, With Sonali Smith, MD [Last Updated On: September 5th, 2011] [Originally Added On: September 5th, 2011]
- Cancer Update: Autologus Stem Cell (Bone Marrow) Transplant [Last Updated On: September 5th, 2011] [Originally Added On: September 5th, 2011]
- Bone Marrow Stem Cell Transplant Live from Top US Hospital [Last Updated On: September 5th, 2011] [Originally Added On: September 5th, 2011]
- Adult Stem Cell Mobilization from Bone Marrow (Animation) [Last Updated On: September 6th, 2011] [Originally Added On: September 6th, 2011]
- Bone Marrow / Stem Cell Transplant Recovery Fund [Last Updated On: September 7th, 2011] [Originally Added On: September 7th, 2011]
- Bone Marrow Stem Cell Expansion by HOXB4 and p21 Knock Out [Last Updated On: September 10th, 2011] [Originally Added On: September 10th, 2011]
- Adult Stem Cell Mobilization from Bone Marrow (Animation) [Last Updated On: September 10th, 2011] [Originally Added On: September 10th, 2011]
- Bone Marrow/Stem Cell Transplant [Last Updated On: September 10th, 2011] [Originally Added On: September 10th, 2011]
- Bone Marrow/Stem Cell Transplant [Last Updated On: September 11th, 2011] [Originally Added On: September 11th, 2011]
- Macular Degeneration Improved With Stem Cells [Last Updated On: September 12th, 2011] [Originally Added On: September 12th, 2011]
- Stem Cell Transplant India,Bone Marrow Transplant India,Sickle Cell Anemia Treatment India [Last Updated On: September 20th, 2011] [Originally Added On: September 20th, 2011]
- Nurses Discuss Special Bonds With Bone Marrow and Stem Cell Transplant Patients [Last Updated On: September 20th, 2011] [Originally Added On: September 20th, 2011]
- Becoming a Blood Stem Cell Donor [Last Updated On: September 20th, 2011] [Originally Added On: September 20th, 2011]
- Bone Marrow and Stem Cell Transplant Patients Share Their Stories [Last Updated On: September 20th, 2011] [Originally Added On: September 20th, 2011]
- LittleBigPlanet 2 - (WIP) Stem Cell Sackboy Bone Marrow Bugaloo [Last Updated On: September 20th, 2011] [Originally Added On: September 20th, 2011]
- LittleBigPlanet 2 - Stem Cell Sackboy Quarter 4 Update (Bone Marrow Bugaloo) [Last Updated On: September 22nd, 2011] [Originally Added On: September 22nd, 2011]
- Bone Marrow Transplant Program Continues to Grow, Make a Difference [Last Updated On: September 23rd, 2011] [Originally Added On: September 23rd, 2011]
- Can Stem Cell Prolotherapy or Bone Marrow Prolotherapy help articular cartilage defects? [Last Updated On: September 23rd, 2011] [Originally Added On: September 23rd, 2011]
- Multiple Sclerosis, Stem Cells, and Hope, Part 2 [Last Updated On: September 23rd, 2011] [Originally Added On: September 23rd, 2011]
- Bone Marrow Transplant Program Continues to Grow, Make a Difference [Last Updated On: September 23rd, 2011] [Originally Added On: September 23rd, 2011]
- How to be an Anthony Nolan blood stem cell donor [Last Updated On: September 23rd, 2011] [Originally Added On: September 23rd, 2011]
- Stem Cells extracted from bone marrow [Last Updated On: September 23rd, 2011] [Originally Added On: September 23rd, 2011]
- Calum's stem cell donation for Anthony Nolan [Last Updated On: September 23rd, 2011] [Originally Added On: September 23rd, 2011]
- Cancer Update: Autologus Stem Cell (Bone Marrow) Transplant [Last Updated On: September 23rd, 2011] [Originally Added On: September 23rd, 2011]
- Bone Marrow - Stem Cell Prolotherapy [Last Updated On: September 24th, 2011] [Originally Added On: September 24th, 2011]
- Bone Marrow Stem Cell Aspiration and Re-Injection with PRP for Osteoarthritis by Dr Adelson [Last Updated On: September 24th, 2011] [Originally Added On: September 24th, 2011]
- Mesenchymal stem cells and marrow stromal cells---2nd--- [Last Updated On: September 25th, 2011] [Originally Added On: September 25th, 2011]
- Stem Cell Injections - Bone Marrow Prolotherapy - treatment for arthritis [Last Updated On: September 25th, 2011] [Originally Added On: September 25th, 2011]
- Chat w/ Dr. Maharaj, founder of S. FL. Bone Marrow/Stem Cell Transplant Institute [Last Updated On: September 25th, 2011] [Originally Added On: September 25th, 2011]