PALO ALTO, Calif., Oct. 18 /PRNewswire-FirstCall/ -- Avicena Group, Inc. , a late stage biotechnology company focused on commercializing its proprietary cellular energy regulation technology, announced today that patient enrollment for the first stage of its Phase II ALS (amyotrophic lateral sclerosis, also known as Lou Gehrig’s Disease) clinical trial has been completed by the trial’s lead investigator, Paul H. Gordon, M.D., of the Eleanor and Lou Gehrig MDA/ALS Research Center at Columbia University in New York. In this trial, investigators will assess the efficacy, safety and tolerability of Avicena’s proprietary ALS-08 drug candidate in separate combinations with minocycline and celecoxib (a COX-2 inhibitor).
“Completion of patient enrollment for this stage is an important step in the advancement of our clinical drug development program for ALS,” said Chief Executive Officer Belinda Tsao-Nivaggioli, Ph.D. “The unique study design allows for an effective assessment of the neuron-protective potential of ALS-08 in combination with two separate agents that have shown to influence different mechanisms of neurodegeneration.”
This more efficient study design utilizes a two-stage Phase II protocol to determine a superior combination drug candidate. In the first stage of this six-month, multi-center, double-blinded trial, 86 ALS patients were enrolled. Patients were randomly assigned to one of two combination treatment arms: ALS-08 and minocycline or ALS-08 and celecoxib. Following treatment, investigators will assess the mean difference in ALSFRS-R (revised ALS Functional Rating Scale) between the two treatment arms. If the mean difference between the two treatment groups achieves a pre-defined hurdle rate, the trial is judged to be complete. Only if the pre-defined hurdle rate is not achieved will this Phase II trial continue with a second enrollment stage. For stage two, up to an additional 60 patients would be enrolled and randomly assigned to one of the two treatment arms. Following trial completion, the superior combination therapy will be selected for further study in a Phase III clinical trial.
In addition to the primary ALSFRS-R endpoint, investigators will assess the following secondary outcomes: Safety and Tolerability; Change in Forced Vital Capacity (FVC, percent predicted); Timed Get Up and Go Test (TGUG); Quality of Life; as well as Survival. Investigators will also assess whether the combination drug candidates are safe and well tolerated in conjunction with riluzole, the only FDA-approved ALS drug.
This study is supported by the ALS Association, Ride for Life, and the Russ Bowen and Spina Family foundations.
ABOUT ALS
Amyotrophic Lateral Sclerosis (ALS), also known as “Lou Gehrig’s disease,” is a progressive neurodegenerative disease that attacks the motor neurons of the brain and spinal cord that are responsible for voluntary muscle movement leading to degeneration of the voluntary motor system. As these motor neurons degenerate, their ability to send impulses to the muscle fibers is compromised. There are approximately 30,000 individuals suffering from ALS in the United States at any one time. There is presently no known cure for ALS.
ABOUT THE AVICENA GROUP
The Avicena Group, Inc. is a late stage, revenue generating biotechnology company focused on developing products based on its proprietary understanding of the regulation of cellular energy processes. The company’s core technologies, supported by a robust IP portfolio, have broad applications in both pharmaceuticals and dermaceuticals. Avicena’s pharmaceutical program centers on rare neurological disorders (orphan diseases). The company is currently analyzing data from its Phase IIb/ III trial in ALS (Amyotrophic Lateral Sclerosis, or Lou Gehrig’s Disease). Near term, Avicena intends to initiate both a Phase III trial in Huntington’s Disease and a Phase III trial in Parkinson’s Disease. Avicena presently derives revenue from the sale of proprietary ingredients to skin care manufacturers. Furthermore, the company is developing a proprietary line of therapeutic skin care products. Avicena’s science is well established and its products are safe and well tolerated. Unlike traditional biotechnology companies, Avicena’s clinical programs are largely funded by government and non-profit organizations.
This release may contain forward-looking statements within the meaning of the federal securities laws. Such forward-looking statements reflect, among other things, management’s current expectations, plans and strategies, and anticipated financial results, all of which are subject to known and unknown risks, uncertainties and factors that may cause our actual results to differ materially from those expressed or implied by these forward-looking statements. Many of these risks are beyond our ability to control or predict. See “Risk Factors” in the company’s prospectus and annual report for a discussion of such risks, including the company’s need for additional funds, the company’s dependence on a limited number of therapeutic compounds, the early state of the products the company is developing, uncertainties relating to clinical trials and regulatory reviews, competition and dependence on collaborative partners, the company’s ability to avoid infringement of the patent rights of others, and the company’s ability to obtain adequate patent protection and to enforce these rights. Because of these risks, uncertainties and assumptions, you should not place undue reliance on these forward-looking statements. Furthermore, forward-looking statements speak only as of the date they are made. Avicena does not undertake any obligation to update or review any such forward-looking information, whether as a result of new information, future events or otherwise.
Contact: The Ruth Group Stephanie Carrington / John Quirk (investors) 646-536-7017 / 7029 scarrington@theruthgroup.comjquirk@theruthgroup.com Janine McCargo (media) 646-536-7033 jmccargo@theruthgroup.com
Avicena Group
CONTACT: investors, Stephanie Carrington, +1-646-536-7017, orscarrington@theruthgroup.com, or John Quirk, +1-646-536-7029, orjquirk@theruthgroup.com, or media, Janine McCargo, +1-646-536-7033, orjmccargo@theruthgroup.com, all of The Ruth Group for the Avicena Group
Web site: http://www.avicenagroup.com/
