Yahoo Finance FDA Approves Clinical Trial of BrainStorm Cell Therapeutics’ ALS Treatment
BrainStorm Cell Therapeutics’ (OTCQB:BCLI - News) stock volume skyrocketed Apr. 28, with 3,714,379 shares changing hands, more than 5 times its three-month average volume of 718,105 shares.
The sudden surge in volume is being fueled by the New York-based bio-tech company’s Apr. 28 announcement that the U.S. Food and Drug Administration (FDA) has approved commencement of its Phase II clinical trial with NurOwn(TM) in patients with Amyotrophic Lateral Sclerosis (ALS).
The trial will be launched initially at the Massachusetts General Hospital (MGH) in Boston, MA and the University of Massachusetts Memorial (UMass) Hospital in Worcester, MA following Institutional Review Board (IRB) approvals.
Dana-Farber Cancer Institute's Connell O'Reilly Cell Manipulation Core Facility will manufacture the NurOwn(TM) cells for these two clinical sites. The trial will also be conducted at the Mayo Clinic in Rochester, Minnesota.
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Significant Milestone
"Today's announcement represents the most significant milestone BrainStorm has achieved to date," said BrainStorm’s President Chaim Lebovits. "More importantly, in our view, it has positive implications for the entire ALS community, indicating that the FDA recognizes the significant clinical potential of transplantation with our autologous, differentiated mesenchymal stem cells. We are excited to begin the US trial and are optimistic that the Phase II data will confirm the positive indications of clinical benefit we observed in earlier studies. This trial will be the first Phase II double-blinded stem cell study to be conducted for ALS.," he added.
"Following successful completion of the technology transfer process for BrainStorm's NurOwn cells, we are looking forward to collaborating on this multi-center study as the cell production facility for the Massachusetts clinical sites," added Professor Jerome Ritz, Department of Medicine, Harvard Medical School,
On Apr. 28, E BCLI’s share price closed at 30 cents, up 2 cents from the previous day’s close of 28 cents a share.
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Elite Pharmaceuticals Granted New Patent for its Abuse-Deterrent Technology
In other news, Elite Pharmaceuticals Inc. (OTCBB:ELTP - News) announced Apr. 22 the issuance of U.S. Patent No. 8,703,186 titled "Abuse-Resistant Oral Dosage Forms and Method of Use Thereof."
This patent expands the intellectual property for the Northvale, N.J.-based pharmaceutical company’s opioid abuse deterrent technology. Elite now has three U.S. patents and one Canadian patent issued in this area with additional patents pending in the United States., Canada and Europe.
"We are pleased with this additional patent coverage," stated Elite’s President and CEO Nasrat Hakim. "Elite's abuse deterrent program has made significant progress. In December, a successful pilot bioequivalence study for ELI-201 was completed and in January a successful pivotal bioequivalence study for ELI-200 was completed. These products are the first of our many abuse deterrent opioid products under development," he added.
About Elite's Abuse Deterrent Technology
Elite's abuse deterrent products utilize the company’s proprietary pharmacological abuse deterrent technology.
Elite’s abuse deterrent technology is a multi-particulate capsule which contains an opioid agonist in addition to naltrexone, an opioid antagonist. Naltrexone is an opioid receptor antagonist used primarily in the management of alcohol dependence and opioid dependence.
When this product is taken as intended, the naltrexone is designed to pass through the body unreleased while the opioid agonist releases over time providing therapeutic pain relief for which it is prescribed.
If the multi-particulate beads are crushed, the opioid antagonist, naltrexone, is designed to release. The absorption of the naltrexone is intended to block the euphoria by preferentially binding to same receptors in the brain as the opioid agonist and thereby reducing the incentive for abuse or misuse by recreational drug abusers.
On Apr. 28, ELTP’s share price closed at 39 cents, up 1 cent from the previous day’s close of 38 cents a share.
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InVivo Therapeutics Holdings Begins First Clinical Trial of Neuro-Spinal Scaffold
Meanwhile, InVivo Therapeutics Holdings Corp.’s (OTCQB:NVIV - News) stock volume also soared Apr. 29, with 710,895 shares changing hands, nearly 5 times more than its three-month average volume of 150,566 shares.
The uptick in stock volume comes on the heels of the Cambridge, Mass.-based medical device maker’s Apr. 28 announcement that it has begun shipment of its innovative investigational device.
The new product is a degradable polymer Neuro-Spinal Scaffold for spinal cord injury (SCI) patients, for initiation of the company's first clinical trial.
InVivo has pioneered a new treatment platform utilizing a biocompatible polymer-based device that is intended to promote structural support for spinal cord regeneration while improving functional recovery and prognosis after a traumatic SCI.
Estimated 10-Billion Market
The company estimates the worldwide market for treating acute complete SCI to be over $500 million annually, and the chronic SCI market to be over $10 billion. This is the first in-human trial of InVivo's novel investigational device, a critical step in addressing a major unmet need for patients with SCI.
This first clinical study, which is approved by the FDA, is a pilot trial to capture preliminary safety and effectiveness data of the Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. The Company then expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption (HDE).
Scaffold Designed to Facilitate Neural Growth in Spinal Cord Injury
The initial clinical site, The University of Arizona Medical Center in Tucson, AZ, has received Institutional Review Board (IRB) approval and has executed all necessary contracts with InVivo. Surgical training will occur upon receipt of the Neuro-Spinal Scaffold, allowing the site to then begin subject enrollment. Ali A. Baaj, MD, Assistant Professor of Surgery and Director of the Spinal Neurosurgery
On Apr. 28, NVIV’s share price closed at $1.84, up 34 cents from the previous day’s close of $1.50 a share.
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Cellceutix Corp.’s Stock Volume Soars for Second Day in a Row
Finally, Cellceutix Corp.’s (OTCQB:CTIX - News) stock volume continued to soar Apr. 28, with 783,919 shares changing hands, nearly 4 times its three-month average volume of 214,300 shares.
The surge in volume comes less than two weeks after the Beverly, Mass.-based pharmaceutical company reported favorable results in a recently completed preclinical study evaluating its new antibiotic compounds against specific strains of multi-drug resistant Klebsiella pneumoniae.
The research, which is government funded through existing grants to research institutions, is being conducted at a major university in Texas.
In a thigh burden study of a multi-drug resistant strain of Klebsiella pneumoniae in a mouse model, Cellceutix's defensin mimetic compound CTIX1278, was efficacious as compared to a carbapenem antibiotic that is widely used as a last line of defense against drug-resistant, Gram-negative bacteria, including Klebsiella pneumoniae.
A second study is now being conducted at multiple dosing levels with various infusion parameters with the goal of increasing efficacy and further defining a treatment protocol for the compound.
"This is highly encouraging early data of CTIX1278 as it is the first example of efficacy in vivo with one of our defensin mimetic compounds versus Klebsiella pneumoniae," said Dr. Krishna Menon, chief scientific officer at Cellceutix.
On Apr. 28, CTIX’s share price on closed at $1.83, up 15 cents from previous day’s share price of $1.68.
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