PALO ALTO, Calif., Jan. 24 /PRNewswire/ -- Avicena Group, Inc., a developer of novel pharmaceutical and therapeutic products, announced today that findings from a Phase I/II study of its proprietary drug candidate for the treatment of Huntington's disease (HD-02) demonstrated that the drug was safe and well-tolerated by patients at a dose of eight grams/day. Additionally, patients receiving HD-02 experienced elevated serum and brain levels of creatine. Results from this study, which was supported by the National Center for Complementary and Alternative Medicine (NIH/NCCAM), were published today in the journal Neurology.
Additional findings from the trial showed that serum 8-hydroxy-2'- deoxyguanosine (serum 8OH2'dG) levels, which are markedly elevated in Huntington's disease patients, were reduced for patients receiving HD-02. Some researchers believe that this decrease in serum 8OH2'dG may suggest reduced oxidative injury in patients with Huntington's disease.
"We are very encouraged by the outcome of this important study. Not only did our data show that HD-02 is safe and well-tolerated, but we were also able to collect compelling evidence to indicate that the compound may reduce oxidative injury in patients with Huntington's disease," stated Steven Hersch, M.D., Ph.D., director, Laboratory of Neurodegeneration and Neurotherapeutics, MassGeneral Institute for Neurodegenerative Disease (MIND), Massachusetts General Hospital, Harvard Medical School and the study's lead investigator. "This study's findings clearly support the further evaluation of HD-02 as a potential neuroprotective treatment for Huntington's disease."
HD-02 is a proprietary therapeutic that incorporates an ultra-pure, clinical form of creatine that has demonstrated the ability to improve neurological function in certain patient populations. The 64 patients enrolled in this multi-site, double-blind, placebo-controlled trial were randomized to receive either eight grams of HD-02 or placebo each day for 16 weeks. The treatment period was followed by an eight-week washout period. Following the washout period, elevated serum and brain creatine concentrations returned to pre-treatment levels for patients receiving HD-02.
The study's investigators intend to use the findings from this trial to design late-stage studies of HD-02 aimed at examining the drugs' ability to slow or halt the progression of Huntington's disease. Dr. Hersch, NIH/NCCAM, and Avicena are currently examining higher doses of the compound in a dose- escalation study, as well as a Phase II open-label trial.
"We are very pleased with the data from this study, as these findings will allow us to optimally design the upcoming studies in our Huntington's disease program," said Belinda Tsao-Nivaggioli, Ph.D., Avicena's chief executive officer. "Our continued clinical success with regard to our Huntington's disease compound, as well as our late-stage ALS and Parkinson's disease programs, place Avicena in the position of having multiple drug candidates advancing rapidly through clinical development."
ABOUT HUNTINGTON'S DISEASE
Huntington's disease is a progressive neurodegenerative disease that is caused by a defective gene. This genetic defect, which is often inherited, causes the deterioration of neurons in those parts of the brain that are responsible for controlling cognitive, emotional and motor functions. As a result, patients suffer a variety of symptoms including uncontrollable muscle movements, clumsiness, memory loss, and, ultimately, severe mental deterioration. In the United States, approximately 35,000 people suffer from Huntington's disease. There is presently no known cure for Huntington'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 small patient populations (orphan drugs) and 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 Parkinson's disease and Huntington's disease (HD) into Phase II development.
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.
Contact: Vida Communication (on behalf of the Avicena Group) Stephanie Diaz (investors) Tim Brons (media) 415-675-7400 415-675-7402 sdiaz@vidacommunication.comtbrons@vidacommunication.com
Avicena Group, Inc.CONTACT: investors, Stephanie Diaz, +1-415-675-7400, orsdiaz@vidacommunication.com, or media, Tim Brons, +1-415-675-7402, ortbrons@vidacommunication.com, both of Vida Communication for Avicena Group,Inc.
Web site: http://www.avicenagroup.com/
