PALO ALTO, Calif., May 14 /PRNewswire-FirstCall/ -- Avicena Group, Inc. , a late stage biotechnology company focused on commercializing its proprietary cellular energy modulation technology, announced today the initiation of a Phase I study of AL-02 in subjects with Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig’s disease). AL-02 has shown neuroprotective effects that may potentially slow the progression of this neurodegenerative disease.
Avicena’s Phase I study is an open-label, single-center, dose escalation study designed to establish the serum pharmacokinetics (PK) of AL-02 at three doses (5 gm twice-daily (“BID”), 10 gm BID, and 15 gm BID) to determine the optimal dose for later stage clinical studies. Principal Investigator Allitia DiBernardo, M.D., is expected to enroll six patients with sporadic ALS within approximately one month at the Neurology Clinical Trials Unit (NCTU) at Massachusetts General Hospital.
In addition to establishing an optimal dose for further study, the trial will also evaluate brain concentration levels of AL-02 pre- and post-treatment via MR spectra (MRS) measurement. During the seven-week study, patients with sporadic ALS will receive escalating doses of AL-02 for three weeks. PK analysis will be performed at the end of each week and MRS imaging will be conducted throughout the study to measure changes in brain metabolite levels.
Belinda Tsao-Nivaggioli, Ph.D., CEO of Avicena, stated, “The initiation of this trial is an important clinical development milestone within our ALS program. We plan to announce the dose-escalation results in mid-2007, and using the optimal dose identified, we intend to advance AL-02 into additional later-stage clinical trials.”
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. 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 patients. A 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.
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 the NIH sponsored Phase III trial in Parkinson’s disease described in this release. 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, 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, Sara Ephraim, +1-646-536-7002,sephraim@theruthgroup.com, Media - Janine McCargo, +1-646-536-7033,jmccargo@theruthgroup.com, Jason Rando, +1-646-536-7025,jrando@theruthgroup.com, all of The Ruth Group for Avicena Group
