PALO ALTO, Calif., March 22 /PRNewswire-FirstCall/ -- The Avicena Group, Inc. (Avicena) announced today that the United States Food and Drug Administration (FDA) has granted orphan drug designation to HD-02, the company’s proprietary drug candidate for the treatment of Huntington’s disease.
The company recently announced the publication of positive Phase I/II data for HD-02 in the journal Neurology. The findings showed that the drug was safe and well-tolerated by patients at a dose of eight grams/day, while resulting in elevated serum and brain levels of creatine. Additional findings demonstrated that HD-02 reduced serum 8-hydroxy-2'-deoxyguanosine (serum 8OH2’dG) levels, which are markedly elevated in HD patients. Some researchers believe that this decrease in serum 8OH2’dG may suggest reduced oxidative injury in patients with Huntington’s disease. 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.
Orphan drug designation is designed to provide developers of orphan drug products with incentives including: eligibility for seven-year marketing exclusivity following drug approval; tax credits for clinical research; reduced NDA filing fees; grants for further clinical research and development; and assistance with the review of clinical trial protocols. Additionally, orphan drug designation typically results in expedited FDA marketing review times as compared to other drugs. This is due to the fact that those conditions classified as orphan drug diseases are serious or life-threatening and afflict less than 200,000 patients annually in the U.S.
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 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.
Contact: Avicena Group, Inc. Vida Communication Belinda Tsao-Nivaggioli, Ph.D. Stephanie Diaz (investors) Chief Executive Officer 415-675-7400 415-397-2880 sdiaz@vidacommunication.com Tim Brons (media) 415-675-7400 646-319-8981 (mobile) tbrons@vidacommunication.com
Avicena Group, Inc.
CONTACT: Belinda Tsao-Nivaggioli, Ph.D., Chief Executive Officer ofAvicena Group, Inc., +1-415-397-2880; or investors, Stephanie Diaz,+1-415-675-7400, or sdiaz@vidacommunication.com, or media, Tim Brons,+1-415-675-7400, or +1-646-319-8981 (mobile), ortbrons@vidacommunication.com, both of Vida Communication, for AvicenaGroup, Inc.
Web site: http://www.avicenagroup.com/
