PALO ALTO, Calif., April 23 /PRNewswire-FirstCall/ -- Avicena Group, Inc. , a late stage biotechnology company focused on commercializing its proprietary cellular energy modulation technology, announced today that it has filed a composition of matter patent application with the United States Patent and Trademark Office for Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig's disease), a severe neurodegenerative disease.
This composition of matter patent broadly covers pharmaceutical formulations based on creatine derivatives alone or in combination with an anti-inflammatory compound for the treatment of ALS. The Company believes that this patent will provide additional IP protection for its current and future generation drug candidates formulated to treat ALS which extends beyond the existing use patents previously issued to Avicena with claims in neurology (US Patents 6,196,115 B1 and 6,706,764 B2). This application will further extend Avicena's intellectual property portfolio for ALS-02, a drug candidate that has previously been granted orphan drug designation by the US FDA.
Belinda Tsao-Nivaggioli, Ph.D., CEO of Avicena, stated, "This patent application is another key intellectual property milestone that builds shareholder value and will help us further protect the Company's cellular energy franchise and the drug candidates we develop for ALS. ALS remains a leading indication for our technology, and this additional patent application will support our commercialization work in this important therapeutic area."
ABOUT ALS
ALS is a 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. The progressive degeneration of motor neurons eventually leads to neuron death resulting in the brain's inability to initiate or control muscle movement. Once a patient's muscles no longer receive the messages that they require to function, muscles begin to atrophy. With an incidence rate of approximately 1 in 10,000, ALS affects roughly 30,000 Americans at any given time. Each year, approximately 5,600 new cases of ALS are diagnosed. The two types of ALS are "sporadic ALS," which accounts for approximately 85% - 90% of all cases; and "familial ALS," which accounts for the remaining 10% - 15% of patents.
ABOUT AVICENA
Avicena Group, Inc. is a late stage 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 a Phase III trial in Huntington's disease to accompany its on-going 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 ingredients to skin care manufacturers.
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" 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, 2005, 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) John Quirk / Sara Ephraim / (investors) (646) 536-7029 / 7002 Janine McCargo / Jason Rando (media) (646) 536-7033 / 7025
Avicena Group, Inc.CONTACT: Investors: John Quirk, +1-646-536-7029, or Sara Ephraim,+1-646-536-7002, or Media: Janine McCargo, +1-646-536-7033, or Jason Rando,+1-646-536-7025, all of The Ruth Group for Avicena Group
