PALO ALTO, Calif., March 14 /PRNewswire-FirstCall/ -- Avicena Group, Inc. ("Avicena"), a developer of novel pharmaceutical and therapeutic products, announced today results from a Phase II study designed to evaluate whether further study is warranted for PD-02, a proprietary Avicena drug candidate, and the antibiotic minocycline, as potential treatments for Parkinson's disease. Data demonstrated that neither PD-02 nor minocycline was found to be futile as compared to predetermined thresholds, suggesting both agents may be worthy of further consideration as potential therapeutics. Results from this study, which was sponsored by the National Institute of Neurological Disorders and Stroke (NIH/NINDS), were published today in the journal Neurology.
This randomized, Phase II, multi-center, double-blind trial enrolled 200 early, untreated Parkinson's disease patients into three different treatment arms (PD-02, 10 grams per day; minocycline, 200 mg per day; or placebo). After twelve months of daily treatment, investigators found that the rate of disease progression for both PD-02 and minocycline was lower than the threshold for futility, as measured by the Unified Parkinson's Disease Rating Scale (UPDRS). Additionally, PD-02 was found to be safe and generally well-tolerated by the subjects during this study.
"We are pleased with the results of this trial. The compounds were found to be generally well tolerated by the subjects participating in the trial," said Karl Kieburtz, MD, M.P.H., Director, Clinical Trials Coordination Center, University of Rochester. "While these findings were encouraging for both PD-02 and minocycline, we want to emphasize that further research would be needed to determine if either agent can slow the progression of Parkinson's disease."
PD-02 is a proprietary therapeutic that incorporates an ultra-pure, clinical form of creatine. This ultra-pure, clinical form of creatine has demonstrated the potential to improve neurological function in certain patient populations. In preclinical animal studies of Parkinson's disease, PD-02 has demonstrated significant neuroprotective properties including protection of the dopaminergic cells, which are affected in Parkinson's disease.
"Based on the findings from this trial and our strong ongoing relationships with the University of Rochester and NINDS, we are now discussing the potential initiation of a Phase III efficacy trial to evaluate if PD-02 modifies the progression of Parkinson's disease," stated Belinda Tsao-Nivaggioli, Avicena's chief executive officer. "This potential trial, combined with our ongoing Phase III program in ALS and Phase II program in Huntington's disease, places us in the strong position of having multiple late-stage clinical programs targeting patients in need of new, effective therapies."
A separate paper outlining the design of this futility study, authored by Barbara C. Tilley, Ph.D., Professor and Chair, Department of Biostatistics, Bioinformatics & Epidemiology, Medical University of South Carolina and colleagues, was also published today in Neurology.
ABOUT FUTILITY STUDIES
Futility trials are unique Phase II studies designed to assess whether it is worthwhile to consider evaluating drug candidates in Phase III efficacy trials. In measuring outcomes of specific compounds against predetermined thresholds, investigators are able to discard those treatments deemed unlikely to be effective in Phase III trials. As a result, these studies may decrease the time to identify treatments unworthy of further pursuit and reduce subjects' exposure to futile treatments. Futility trials, which have most often been used in evaluating cancer therapeutics, are particularly attractive in those diseases, such as Parkinson's disease, for which a number of agents are being considered for investigation.
ABOUT PARKINSON'S DISEASE
Parkinson's disease is a progressive, neurodegenerative brain disorder that occurs when the neurons within the brain that are responsible for producing the chemical dopamine die. Primary symptoms of the disease include involuntary shaking of the arms or legs (tremors), difficulty with balance, slowness of movement, and stiffness.
It is estimated that roughly 1.5 million Americans are affected by Parkinson's disease, making it the second most common neurodegenerative disease after Alzheimer's disease. Approximately 60,000 new cases are diagnosed each year in the United States. There presently is no known cure for Parkinson's disease.
ABOUT AVICENA
Based in Palo Alto, CA, Avicena is a biotechnology company that seeks to develop and commercialize therapeutic products that regulate the critical energy processes which occur within human cells. Avicena's focus is on the development of pharmaceutical products to treat patients with rare diseases (orphan drugs), as well as dermaceutical products. To date, the company has advanced certain compounds for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) into Phase III trials and treatments for Huntington's disease (HD) into Phase II development. Having completed Phase II trials, the company is now considering a Phase III trial for the treatment of Parkinson's disease.
SAFE HARBOR
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 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.
Avicena Group, Inc.CONTACT: investors, Stephanie Diaz, +1-415-675-7400, orsdiaz@vidacommunication.com, or tbrons@vidacommunication.com, or media, TimBrons, +1-415-675-7400, or mobile, +1-646-319-8981, both of VidaCommunication, for Avicena Group, Inc.
