PALO ALTO, Calif., June 28 /PRNewswire-FirstCall/ -- Avicena Group, Inc. , a late stage biotechnology company that develops central nervous system therapeutics for neurodegenerative diseases, announced today the selection of the optimal dose of HD-02, its novel drug candidate for the treatment of Huntington’s Disease. This dose was determined in an open-label dose escalation study, led by Dr. Steven Hersch and Dr. Diana Rosas of Massachusetts General Hospital (MGH), and will be further evaluated in a Phase III clinical trial.
The dose escalation study evaluated HD-02 in a range of doses from 10 to 40 grams per day and successfully determined the optimal dose that provided the maximum efficacy, safety and tolerability. The full scope of the data will be disseminated upon the results being peer reviewed.
Based on these findings, Avicena and its collaborators Dr. Hersch and the Huntington Study Group have developed a double-blind, placebo-controlled Phase III clinical trial anticipated to commence in early 2008. The Phase III trial will be one of the single largest trials for Huntington’s patients, with external funding to be announced.
Upon commencement of this clinical trial, Avicena will have advanced three different indications into phase III trials that include some of the largest trial to date in both Parkinson’s and Huntington’s.
“We are very encouraged by the results of our HD-02 trial and we believe that in conjunction with our collaborators at MGH, we have identified the optimal dose as we move forward to validate HD-02 as a potential treatment for Huntington’s disease, for which there is no current approved drug by the FDA. We are committed to developing therapeutics that we hope can slow the progression of neurodegenerative diseases,” stated Belinda Tsao-Nivaggioli, CEO of Avicena.
“We are excited by the results of our studies with HD-02 to date. This Phase III study will evaluate whether HD-02 can slow the progression of Huntington’s disease and translate into real-world clinical benefits for patients,” stated lead investigator Dr. Steven Hersch.
ABOUT HD-02
HD-02 is a novel drug candidate for the treatment of Huntington’s disease (HD) with orphan drug designation in the U.S. Avicena has recently completed a Phase II clinical study of HD-02 led by Dr. Steven Hersch of Massachusetts General Hospital. Results from this study, which were published in the January 24, 2006 issue of Neurology, showed that HD-02 reduced the Huntington’s disease marker, which some researchers have linked to brain injury. Further studies by Dr. Hersch and Dr. Rosas have optimized the dosing of HD-02 and provided further evidence supporting its potential to slow HD.
Earlier preclinical studies performed by Dr. Flint Beal of Cornell Medical Center and Dr. Robert Ferante of Boston University, HD-02 have shown significant neuroprotective effects such as improved motor movement and increased survival rate.
Avicena intends to collaborate with Dr. Hersch and the Huntington Study Group to initiate a Phase III trial in early 2008 following completion of a chronic toxicology study that is currently underway.
The magazine R&D Directions recently selected HD-02 as one of the “100 Great Investigational Drugs of 2007" in the March 2007 issue.
ABOUT HUNTINGTON’S DISEASE
HD is a progressive neurodegenerative disease caused by a defective gene that is often inherited from parent to child. This genetic defect causes a programmed deterioration of neurons in those parts of the brain that are responsible for controlling cognitive, emotional and motor functions. This progressive deterioration results in a variety of symptoms including uncontrolled muscle movement, loss of intellectual capacity, and severe emotional disturbances.
Approximately 35,000 people in the US suffer from Huntington’s disease and an additional 150,000 Americans are carriers of the Huntington’s gene. Carriers of the Huntington’s gene will develop this deadly disease during their lifetime.
ABOUT AVICENA
Avicena Group, Inc. is a Palo Alto, California based late stage biotechnology company that develops central nervous system therapeutics for neurodegenerative diseases. 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. Near term, Avicena intends to initiate a Phase III trial in Huntington’s disease to accompany the ongoing Phase III trial in Parkinson’s disease. 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. Avicena presently derives revenue from the sale of proprietary dermaceutical ingredients to skin care manufacturers.
SAFE HARBOR
This release contains forward-looking statements that reflect, among other things, management’s current expectations, plans and strategies, 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” under “Item 6. Management’s Discussion and Analysis of Financial Condition and Results of Operation” from our Annual Report on Form 10-KSB for the year ended December 31, 2006, and other descriptions in the company’s public filings with the Securities and Exchange Commission 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 stage 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 (on behalf of Avicena Group) Stephanie Carrington / Sara Ephraim / (investors) (646) 536-7017 / 7002 scarrington@theruthgroup.com or sephraim@theruthgroup.com Janine McCargo / Jason Rando (media) (646) 536-7033 / 7025 jmccargo@theruthgroup.com or jrando@theruthgroup.com
Avicena Group, Inc.
CONTACT: Investors, Stephanie Carrington, +1-646-536-7017,scarrington@theruthgroup.com, or Sara Ephraim, +1-646-536-7002,sephraim@theruthgroup.com, or media, Janine McCargo, +1-646-536-7033,jmccargo@theruthgroup.com, or Jason Rando, +1-646-536-7025jrando@theruthgroup.com
Web site: http://www.avicenagroup.com/
