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Old 05-28-2007, 07:05 PM #1
paula_w paula_w is offline
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paula_w paula_w is offline
In Remembrance
 
Join Date: Aug 2006
Location: Florida
Posts: 3,904
15 yr Member
Default MGH and ALS Research

Avicena Highlights Key Collaborators in Amyotrophic Lateral Sclerosis (ALS) Dose Escalation Study


Investigator-Initiated and Foundation-Funded Study to Test Avicena's ALS Drug Candidate
PALO ALTO, Calif.,
May 25 /

PRNewswire-FirstCall/ -- Avicena Group, Inc.(OTC Bulletin Board: AVGO), a late stage biotechnology company focused oncommercializing its proprietary cellular energy modulation technology,announced today the key collaborators in the recently initiated doseescalation trial to evaluate the Company's ALS-02 drug candidate insubjects with Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig's disease).ALS-02 has shown neuroprotective effects that may potentially slow theprogression of this neurodegenerative disease. The dose-escalation study is being led by principal investigatorAllitia DiBernardo, M.D., at the Neurology Clinical Trials Unit (NCTU) atMassachusetts General Hospital (MGH).

In addition to MGH, the trial isbeing supported with funds donated by the Harvard Center forNeurodegeneration and Repair, and the ALS Therapy Alliance. Avicena, aspart 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 BelindaTsao-Nivaggioli, Ph.D., CEO of Avicena. "We look forward to strengtheningour partnership with MGH and the foundations which have generously providedthe funding for this trial." "As we mentioned last week, the purpose of this study is to identifythe optimal dose of ALS-02 for use in later-stage clinical trials. MGH isexpected to enroll six patients with sporadic ALS to establish the serumpharmacokinetics (PK) of ALS-02 at three doses. By mid-2007, we anticipateresults from this trial that could uncover the optimal dose for furtherevaluation."

ABOUT THE TRIAL This clinical study is an open-label, single-center, dose escalationstudy designed to establish the serum pharmacokinetics (PK) of ALS-02 atthree doses (5 gm twice-daily ("BID"), 10 gm BID, and 15 gm BID) and todetermine the optimal dose for later stage clinical studies. PrincipalInvestigator Allitia DiBernardo, M.D., will lead the trial at the NeurologyClinical Trails Unit (NCTU) at Massachusetts General Hospital. In addition to establishing an optimal dose for further study, thetrial will also evaluate brain concentration levels of ALS-02 pre- andpost- treatment via MR spectra (MRS) measurement. During the seven-weekstudy, patients with sporadic ALS will receive escalating doses of ALS-02for three weeks. PK analysis will be performed at the end of each week andMRS imaging will be conducted throughout the study to measure changes inbrain metabolite levels. ABOUT ALS ALS is a neurodegenerative disease that attacks the motor neurons ofthe brain and spinal cord that are responsible for voluntary musclemovement. As these motor neurons degenerate, their ability to send impulsesto the muscle fibers is compromised. Once a patient's muscles no longerreceive the messages that they require to function, muscles begin toatrophy. With an incidence rate of approximately 1 in 10,000, ALS affectsroughly 30,000 Americans at any given time. Each year, approximately 5,600new cases of ALS are diagnosed. The two types of ALS are "sporadic ALS,"which accounts for approximately 85% - 90% of all cases; and "familialALS," which accounts for the remaining 10% - 15% of patients.

ABOUT AVICENA Avicena Group, Inc. (OTC Bulletin Board: AVGO) is a late stagebiotechnology company focused on developing products based on itsproprietary understanding of the regulation of cellular energy processes.The company's core technologies, supported by a robust IP portfolio, havebroad applications in both pharmaceuticals and dermaceuticals. Avicena'spharmaceutical program centers on rare neurological disorders (orphandiseases). The company is currently analyzing data from its Phase IIb/IIItrial in ALS. Near term, Avicena intends to initiate a Phase III trial inHuntington's disease to accompany the ongoing Phase III trial inParkinson's disease. Avicena's science is well established and its productsare safe and well tolerated. Unlike traditional biotechnology companies,Avicena's clinical programs are largely funded by government and non-profitorganizations. Avicena presently derives revenue from the sale ofproprietary dermaceutical ingredients to skin care manufacturers.

SAFE HARBOR This release contains forward-looking statements that reflect, amongother things, management's current expectations, plans and strategies, allof which are subject to known and unknown risks, uncertainties and factorsthat may cause our actual results to differ materially from those expressedor implied by these forward-looking statements. Many of these risks arebeyond our ability to control or predict. See "Risk Factors" under "Item 6.Management's Discussion and Analysis of Financial Condition and Results ofOperation" from our Annual Report on Form 10-KSB for the year endedDecember 31, 2006, and other descriptions in the company's public filingswith the Securities and Exchange Commission for a discussion of such risks,including the company's need for additional funds, the company's dependenceon a limited number of therapeutic compounds, the stage of the products thecompany is developing, uncertainties relating to clinical trials andregulatory 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 toenforce these rights. Because of these risks, uncertainties andassumptions, you should not place undue reliance on these forward-lookingstatements. Furthermore, forward-looking statements speak only as of thedate they are made. Avicena does not undertake any obligation to update orreview any such forward-looking information, whether as a result of newinformation, 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
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