HD Lighthouse Contributing Editor's Comment: Creatine is showing real promise as a potential treatment for Huntington's Disease. Avicena is funding a Phase II toxicity study for high dose creatine which will be enrolling soon. Dr. Steven Hersch is applying to NIH for funding for a large Phase III study.

We'll keep you informed about trial enrollment and plans. I'm excited!

-- Marsha L. Miller, Ph.D.
Posted to the HDL: 16 Jan 2007

Avicena Advances Clinical Development of HD-02 for Huntington's Disease

Avicena

Palo Alto, Calif., December 12, 2006 — Avicena Group, Inc. (OTCBB: AVGO), a biotechnology company focused on commercializing its proprietary cellular energy modulation technology, announced today the initiation of a chronic toxicology study of HD-02, its lead candidate for Huntington's disease (HD).

The study marks the latest advancement in the progression of Avicena's HD program and is expected to conclude during the second half of 2007. Upon successful completion of this animal toxicity study, Avicena intends to initiate a Phase III clinical trial.

This study is the next step in the steady development program for HD-02, which has been granted orphan drug designation by the FDA. Results from a previous Phase I/II clinical study of HD-02, published in the January 24, 2006, issue of Neurology, demonstrated that the drug was safe and well-tolerated at a dose of 8 g/day in HD patients. HD-02 patients also showed reduced levels of an oxidative marker, serum 8-hydroxy-2'-deoxyguanosine, which some researchers have linked to reduced oxidative injury in patients with Huntington's disease. Earlier preclinical trials examining the effects of HD-02 in a model of Huntington's disease showed significantly improved survival and slowed the rate of brain atrophy.

"We are continuing to move our HD program forward, and I am very encouraged by the Phase I/II results as well as by our previous clinical and pre-clinical data," stated Belinda Tsao-Nivaggioli, Avicena's chief executive officer. "To date, HD-02 has shown significant potential in Huntington's disease, and based on the results of this toxicology study, we expect to initiate a Phase III trial for HD-02 in 2007."

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 the Avicena Group

The Avicena Group, Inc. (OTCBB: AVGO) 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.

# # #

Source: press release

printer friendly version

 

	Read the HDAC/HDLighthouse Forum. Post your comments