|Amarantus Announces First Alzheimer's Biomarker Services Collaboration for LymPro Test(R); Ocera Announces Preliminary Topline Results From Phase 2a of OCR-002|
|By David Fowler|
|Wednesday, 18 February 2015 20:30|
Amarantus BioScience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on developing diagnostics in neurology, and therapeutic products with the potential for orphan drug designation in the areas of neurology, psychiatry, ophthalmology and regenerative medicine, and Anavex Life Sciences Corp. (Anavex) (OTCQX:AVXL), a biopharmaceutical company dedicated to the development of novel drug candidates to treat Alzheimer's disease (AD), other central nervous system (CNS) diseases, pain and various types of cancer, today announced the execution of a biomarker services agreement in which Amarantus will evaluate the pharmacodynamic effect of ANAVEX 2-73 and ANAVEX PLUS on the expression of the biomarker CD69 in specific sub-populations of peripheral blood lymphocytes using Amarantus' proprietary Alzheimer's blood diagnostic LymPro Test®. In parallel, the companies have entered into a Letter of Intent ("LOI") for Amarantus to assist Anavex in planning the scope of the blood-based biomarker components of Anavex' next larger, potentially Phase 3, Alzheimer's disease clinical trial that is expected to follow the ongoing Phase 2a study currently enrolling subjects to collect additional safety and exploratory efficacy data in mild to moderate AD patients. Initial data from Anavex' Phase 2a AD trial is expected in the third quarter of 2015. ANAVEX 2-73 and ANAVEX PLUS, which combines ANAVEX 2-73 with donepezil (Aricept®), are Anavex' lead drug candidate and drug candidate combination, respectively, for Alzheimer's disease.
"We are pleased to assist Anavex, our first customer, in evaluating the potential of ANAVEX 2-73 and ANAVEX PLUS to increase CD69 expression using LymPro in blood derived from AD patients," said Gerald E. Commissiong, President & CEO of Amarantus. "Based on data generated in two previous peer-reviewed publications, our recently completed LP-002 clinical study, as well as studies presented by Amarantus in 2014 at the Alzheimer Association International Conference, CD69 expression as measured by LymPro is decreased in patients with AD, as compared to healthy controls and patients with confounding dementias. The ability of a new drug candidate to increase CD69 expression, as measured by LymPro, may be indicative of a modification in the fundamental Alzheimer's disease process known as cell cycle dysregulation (a/k/a 'ectopic cell cycle re-entry'). Cell cycle dysregulation has been directly implicated as a key driver of the neuronal death in the areas of the brain affected by AD that is triggered by amyloid beta signaling through Tau. Our premier diagnostics division, Amarantus Diagnostics, is well positioned to add value to pharmaceutical companies' Alzheimer's therapeutics programs by helping them better execute AD therapeutic clinical studies. We will assist companies by enriching the population of subjects enrolling in Alzheimer's clinical studies, the key unmet need for therapeutic Alzheimer's programs, as well as evaluating drug activity of cell cycle dysregulation, and potentially lipidomics and exosomes via an exclusive option agreement the Company currently holds with Georgetown University. We are currently in active discussions with both emerging and large pharma companies as we work to build a significant customer base for blood-based biomarker services in Alzheimer's disease, with the ultimate shared goal of improving the current standard of care used to treat AD. We are positioning Amarantus Diagnostics to be the market leader in Alzheimer's blood-based biomarkers for the Investigational Use Only (IUO) market, and we believe this agreement is the first important revenue generating step in this direction for Amarantus."
"While the Phase 2a clinical trial for ANAVEX 2-73 and ANAVEX PLUS in Alzheimer's disease is currently underway, Anavex is already planning and exploring options for the next stage of clinical trials, potentially Phase 3, for ANAVEX 2-73 and ANAVEX PLUS given the high unmet need in Alzheimer's," said Christopher U. Missling, Ph.D., President and Chief Executive Officer for Anavex. "ANAVEX 2-73 has demonstrated in preclinical studies to block Tau and amyloid-beta proteins and memory deficits by targeting mixed muscarinic and Sigma-1 receptors, targets which are further 'upstream' in the Alzheimer's disease cascade and thus its potential to halt and/or reverse the course of AD. Being an orally available drug candidate combined with a favorable safety profile as established in a recently completed Phase 1 clinical study of ANAVEX 2-73, we are looking forward to collecting continued safety data and exploratory efficacy data in patients. Assuming a successful Phase 2a outcome, we will evaluate the scope of blood-based biomarker services that could be included in the design for our next AD clinical studies for ANAVEX 2-73 and ANAVEX PLUS."
Amarantus recently completed 'Fit-for-Purpose' assay validation for LymPro at Icon Central Laboratories in Farmingdale, NY, enabling the assay to be offered to the pharmaceutical industry for IUO for evaluation of pharmacodynamic changes in CD69 expression, as well as patient screening and pharmacodynamics drug monitoring in therapeutic AD clinical trials. The company is in the process of building a portfolio of pharmaceutical customers preparing to execute clinical studies in AD.
"This is the type of collaboration that becomes possible with new diagnostic tools to help therapeutic interventions in AD. The mechanisms involved may begin to validate emerging targets in the field of AD, and I am excited to help bring this collaboration forward," commented Robert A. Stern, Ph.D., Professor of neurology, neurosurgery, anatomy and neurobiology at Boston University School of Medicine, Director of the Clinical Core of the Boston University Alzheimer's Disease Center, Director of Clinical Research for the CTE Center at Boston University and member of Amarantus Diagnotics Scientific Advisory Board.
Ocera Therapeutics, Inc. (Nasdaq:OCRX) today announced preliminary topline results from a Phase 2a investigator-sponsored study evaluating the company's drug candidate OCR-002 (ornithine phenylacetate) versus placebo in patients with upper gastrointestinal bleeding (UGIB) associated with liver cirrhosis. The data demonstrated a favorable safety profile for OCR-002 and that the drug candidate was well tolerated. The data also supported OCR-002's ability to reduce ammonia levels, elevated levels of which correlate with certain severe and life-threatening liver disorders. In the study, an acute ammonia lowering effect in plasma, as well as higher urinary excretion of ammonia, was observed in patients treated with OCR-002 compared to placebo. The differences in plasma ammonia levels between treatment arms did not reach statistical significance, but the differences in urinary excretion of ammonia were statistically significant.
"Based on these topline data, we are encouraged by the acute ammonia lowering effect and favorable safety profile demonstrated by OCR-002," stated Linda Grais, M.D., chief executive officer of Ocera. "We believe the data further validate our thesis regarding the mechanism of action of our drug candidate and support Ocera's continued development of OCR-002 as a potential treatment for people with severe and acute liver disorders. We'd like to extend our sincere appreciation to the investigative staff and the patients who participated in this trial developed by the late Professor Juan Córdoba, M.D., who wanted to evaluate the potential for OCR-002 to lower ammonia plasma levels in this patient population."
The primary objective was to evaluate the safety and tolerability of OCR-002 and its ability to rapidly reduce plasma ammonia concentration following an episode of acute UGIB in patients with cirrhosis. A total of 38 patients across two university hospital centers in Spain were randomized 1:1 to receive either a 10 grams per day dose of OCR-002 plus standard of care (n=20) or placebo plus standard of care (n=18). Standard of care included fluid support, lactulose and antibiotics. OCR-002 or placebo was administered as a continuous intravenous infusion for a period of 5 days in this double-blind trial.
The data show that OCR-002 resulted in greater absolute and relative reductions in median plasma ammonia versus placebo at 12 hours after baseline (-19.35 microM/L and -19.62% versus -2.0 microM/L and -3.25%, respectively). These observations corresponded to an hourly decline in plasma ammonia over the first 24 hours of infusion of -0.85 microM/L in the OCR-002 group versus -0.24 microM/L in the placebo group. The differences in plasma ammonia levels between treatment arms did not reach statistical significance, which was due in part to the higher than expected variability in plasma ammonia levels. However, there were statistically significant differences in urinary excretion of ammonia, as expressed by a key metabolite phenylacetyl glutamine (PAGN), which the Company believes demonstrates the ability of OCR-002 to reduce ammonia levels.
"Based on the pharmacokinetic data, we believe that a higher dose of OCR-002 will show an even greater ammonia lowering effect," stated Dr. Rajiv Patni, chief development officer of Ocera. "In Ocera's STOP-HE trial, designed to assess the safety and efficacy of OCR-002 in resolving neurocognitive symptoms of acute hepatic encephalopathy in cirrhotic patients with elevated ammonia, patients receive up to 20 grams per day of OCR-002, twice the dose administered to patients in this investigator-sponsored study. STOP-HE is ongoing and we look forward to a planned interim analysis in the near term."
Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced that it has executed definitive securities purchase agreements with several institutional investors for gross proceeds of approximately $23.0 million in a registered direct offering of approximately 3.1 million shares at a price of $7.50 per share.
Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a global provider of spinal fusion technologies, announced today that the Company's President and Chief Executive Officer, Jim Corbett, will present at the 2015 Cowen and Company Healthcare Conference on Wednesday, March 4, 2015 at 9:20 AM Eastern Time at the Boston Marriott Copley Place.
Anavex Life Sciences Corp. (OTCQX:AVXL), a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer's disease, other central nervous system (CNS) diseases, pain and various types of cancer, today reported financial results for the three months ended December 31, 2014.
Angie's List, Inc. (Nasdaq:ANGI) announced today financial results for the quarter and year ended December 31, 2014.
Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a biopharmaceutical development company with a focus on innovative therapies for patients with debilitating diseases, today announced the closing of its public offering of 4,147,358 shares of its common stock at a public offering price of $18.00 per share, which included 509,025 shares sold pursuant to the partial exercise by the underwriters of their option to purchase additional shares.
Coronado Biosciences, Inc. (Nasdaq:CNDO) has obtained an exclusive license to an intravenous (IV) formulation of tramadol for the U.S. market from Revogenex Ireland Ltd., a privately held company in Dublin, Ireland.
Cutera, Inc. (Nasdaq:CUTR), a leading provider of laser and other energy-based aesthetic systems for practitioners worldwide, today announced that its Board of Directors has approved the expansion of its Stock Repurchase Program from $10 million to $40 million, under which the Company is authorized to repurchase shares of its common stock.
Enzymotec Ltd. (Nasdaq:ENZY), a developer, manufacturer and marketer of innovative bio-active lipid ingredients and medical foods, today reported its financial results for the fourth quarter and full year ended December 31, 2014.
ExamWorks Group, Inc. (NYSE: EXAM), a leading provider of independent medical examinations, peer reviews, bill reviews, Medicare compliance, case management, and other related services ("IME services"), today reported financial results for the fourth quarter of 2014.
Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, today announced that Aron Knickerbocker, Chief Business Officer, will present at the RBC Capital Markets 2015 Healthcare Conference on Wednesday, February 25, 2015 at 10:30 AM Eastern Standard Time.
Harvard Bioscience, Inc. (Nasdaq:HBIO), a global developer, manufacturer, and marketer of a broad range of equipment, instruments and solutions to advance life science, has appointed Ryan Atienza to Vice President of Sales, a newly created position, at its Denville Scientific subsidiary, effective February 16.
Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced that the President and CEO of the National Urban League and former Mayor of New Orleans, Marc H. Morial, will be the keynote speaker at the Company's Plainsboro, NJ headquarters in celebration of Black History Month and Integra's Diversity Initiative.
LDR Holding Corporation (Nasdaq:LDRH), a global medical device company focused on designing and commercializing novel and proprietary surgical technologies for the treatment of patients suffering from spine disorders, today reported its financial results for the fourth quarter and year ended December 31, 2014.
mCig® Inc. (OTCBB:MCIG), a leading provider of advanced technologies and solutions to the global cannabis industry, is announcing the appointment of noted Industrial Hemp Consultant Joe Spencer as Executive Vice President of its Hemp Division.
NanoString Technologies, Inc. (Nasdaq:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced that its management is scheduled to present at the Cowen and Company 35th Annual Health Care Conference in Boston.
PRA Health Sciences, Inc. (Nasdaq:PRAH) today reported its financial results for the fourth quarter ended December 31, 2014.
Prothena Corporation plc (Nasdaq:PRTA), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel protein immunotherapy programs, announced today that Gene Kinney, PhD, the Company's Chief Scientific Officer and Head of Research and Development, will be presenting at the 2015 RBC Capital Markets' Healthcare Conference on Wednesday, February 25, 2015, at 9:00 a.m. ET.
Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT), a development-stage oncology and dermatology biopharmaceutical company, announced today that it will present at the 8th Annual European Life Science CEO Forum & Exhibition. Peter Culpepper, CFO and COO, will present on March 3, 2015, at 3:15 pm local time.
Quadrant 4 System Corporation (OTCQB:QFOR) is pleased to announce the signing and implementation of its QHIX Benefits Administration and Private Health Exchange capabilities for HealthSmart.
Receptos, Inc. (Nasdaq:RCPT), a biopharmaceutical company developing therapeutic candidates for the treatment of immune and metabolic diseases, today announced that data from TOUCHSTONE, the Company's Phase 2 trial of RPC1063 in ulcerative colitis (UC), will be reviewed in an oral podium presentation at the ECCO conference on February 21, 2015 in Barcelona, Spain.
Sabra Health Care REIT, Inc. (Nasdaq:SBRA) (Nasdaq:SBRAP) today announced results of operations for the fourth quarter of 2014.
ScripsAmerica, Inc. (OTCBB:SCRC) today announced that the Company's diabetes patient supply program, run through its wholly-owned subsidiary Main Avenue Pharmacy, has enrolled its 500th patient.
Stereotaxis, Inc. (Nasdaq:STXS) and Centre Hospitalier Universitaire (CHU) of Saint-Étienne, France, today announced the installation of the hospital's second Niobe® remote magnetic navigation system for the treatment of complex arrhythmias through electrophysiology (EP) ablation.
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that Eric Bjerkholt, Executive Vice President of Corporate Development and Finance and Chief Financial Officer of Sunesis, will present at the 2015 RBC Capital Markets' Global Healthcare Conference on Wednesday, February 25th at 11:30 AM Eastern Time at the New York Palace Hotel in New York City.
TriVascular Technologies, Inc. (Nasdaq:TRIV) today announced that the Company will release 2014 fourth quarter and year-end financial results after market close on Tuesday, March 3, 2015.