PALO ALTO, Calif., July 6 /PRNewswire-FirstCall/ -- Avicena Group, Inc. (“Avicena”), a developer of novel pharmaceutical and therapeutic products, announced today that a Phase II clinical trial of two combination therapies incorporating ALS-08, one of its proprietary drug candidates for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig’s Disease) has been initiated. Investigators will assess the efficacy, as well as the safety and tolerability, of ALS-08 in separate combinations with celecoxib (a COX-2 inhibitor) and minocycline in patients with ALS.
“We are enthused about this study based on the fact that the ALS- 08/celecoxib and ALS-08/minocycline combinations have demonstrated additive effects in animal models of ALS, reducing neurodegeneration and prolonging survival more than individual agents alone,” said Paul H. Gordon, M.D., assistant professor of neurology, associate medical director of the MDA/ALS Research Center at Columbia University and the study’s lead investigator. “We hope to replicate these findings in ALS patients while also determining which of these two combinations has the most significant impact on disease progression.”
This six-month, multi-center, double-blind controlled trial will enroll up to 120 ALS patients and randomly assign them to one of the two combination treatment arms. The study’s primary endpoint is the change in the revised ALS Functional Rating Scale (ALSFRS-R). Investigators will also assess a number of secondary outcomes including safety and tolerability, as well as additional efficacy measurements related to the ALS-08 combinations. ALS-08 is a proprietary creatine-derivative that is being developed by Avicena as a potential therapeutic for ALS.
“This is a very exciting study for Avicena as it advances another of our proprietary ALS drug candidates into Phase II development,” said Belinda Tsao- Nivaggioli, Ph.D., Avicena’s chief executive officer. “We are dedicated to developing and delivering novel and effective therapies to this patient population and believe that our lead ALS compound, ALS-02, as well as a combination therapy incorporating ALS-08, have the potential to offer much needed treatment options to these individuals.”
This study is also supported by the ALS Association, Ride for Life, and the Russ Bowen and Spina Family foundations. For additional information about participating sites, contact Carolyn Doorish at cd2141@columbia.edu.
ABOUT ALS
Amyotrophic Lateral Sclerosis (ALS), also known as “Lou Gehrig’s disease,” is a progressive neurodegenerative disease that attacks the motor neurons of the brain and spinal cord that are responsible for voluntary muscle movement. As these motor neurons degenerate, their ability to send impulses to the muscle fibers is compromised. There are approximately 30,000 individuals suffering from ALS in the United States at any one time. There is presently no known cure for ALS.
ABOUT THE AVICENA GROUP
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 and nutraceutical 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.
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 and annual report 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
Web site: http://www.avicenagroup.com/
