PALO ALTO, Calif., May 25 /PRNewswire-FirstCall/ -- Avicena Group, Inc. , a late stage biotechnology company focused on commercializing its proprietary cellular energy modulation technology, announced today the key collaborators in the recently initiated dose escalation trial to evaluate the Company’s ALS-02 drug candidate in subjects with Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig’s disease). ALS-02 has shown neuroprotective effects that may potentially slow the progression of this neurodegenerative disease.
The dose-escalation study is being led by principal investigator Allitia DiBernardo, M.D., at the Neurology Clinical Trials Unit (NCTU) at Massachusetts General Hospital (MGH). In addition to MGH, the trial is being supported with funds donated by the Harvard Center for Neurodegeneration and Repair, and the ALS Therapy Alliance. Avicena, as part of its ongoing collaboration with MGH and both of these foundations, will supply ALS-02 for evaluation in the trial.
“MGH continues to be an important collaborator for us,” stated Belinda Tsao-Nivaggioli, Ph.D., CEO of Avicena. “We look forward to strengthening our partnership with MGH and the foundations which have generously provided the funding for this trial.”
“As we mentioned last week, the purpose of this study is to identify the optimal dose of ALS-02 for use in later-stage clinical trials. MGH is expected to enroll six patients with sporadic ALS to establish the serum pharmacokinetics (PK) of ALS-02 at three doses. By mid-2007, we anticipate results from this trial that could uncover the optimal dose for further evaluation.”
ABOUT THE TRIAL
This clinical study is an open-label, single-center, dose escalation study designed to establish the serum pharmacokinetics (PK) of ALS-02 at three doses (5 gm twice-daily (“BID”), 10 gm BID, and 15 gm BID) and to determine the optimal dose for later stage clinical studies. Principal Investigator Allitia DiBernardo, M.D., will lead the trial at the Neurology Clinical Trails 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 ALS-02 pre- and post- treatment via MR spectra (MRS) measurement. During the seven-week study, patients with sporadic ALS will receive escalating doses of ALS-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.
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. 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 patients.
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. 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, +1-646-536-7025,jrando@theruthgroup.com, all of The Ruth Group for Avicena Group, Inc.
Web site: http://www.avicenagroup.com//
