(BW) (NOVOPHARM-BIOTECH)(NVO.) Novopharm Biotech Files IND with the FDA for Phase I/II Clinical Trials of GPI-2A Business Wire
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(BW) (NOVOPHARM-BIOTECH)(NVO.) Novopharm Biotech Files IND with the FDA for Phase I/II Clinical Trials of GPI-2A

BUSINESS WIRE; Tuesday, April 21, 1998


TORONTO--(BUSINESS WIRE)--April 21, 1998--Novopharm Biotech In(TSE:NVO.) Novopharm Biotech Inc. announced that it has submitted an Investigational New Drug Application with the US Food and Drug Administration to conduct Phase IB/II clinical trials of GPI-2A, the Company's lead antisense product targeted for the treatment of HIV/AIDS.

GPI-2A represents the first antisense therapy to undergo clinical testing in Canada. The Company is currently completing a Phase IA clinical trial of GPI-2A in Winnipeg, Manitoba. GPI-2A is a novel antisense compound that is specifically engineered to target the Human Immunodeficiency Virus (HIV) and stop the process of viral replication. It accomplishes this by blocking the sysnthesis of proteins essential for the survival of the virus. Novopharm Biotech believes that GPI-2A will be effective in treating later stages of AIDS, in addition to being safe and effective in combination with currently available theraphies for early stage HIV infection.

The objective of the Phase IB trial is to investigate the tolerability and safety of escalating intravenous and subcutaneous infusions of GPI-2A. The Phase II trial has been designed to evaluate the efficacy, or anti-HIV activity, of GPI-2A in patients that are resistant to currently available HIV therapies or have failed to respond to theraphy with their current regimen.

Dr. Albert Friesen, President of Novopharm Biotech commented "The initial results are very encouraging. I am optimistic about the upcoming clinical trials and look forward to reporting our clinical trial results concerning GPI-2A's efficacy as a potent anti-HIV inhibitor."

Novopharm Biotech's mandate is to become a North American leader in the development and commercialization of innovative and generic biopharmaceutical products. The company is a publicly traded subsidiary of Novopharm Limited one of Canada's largest generic pharmaceutical companies.

This press release contains forward-looking statements which are subject to risks and uncertainties inherent in the process of developing and commercializing human therapeutics. Actual results could differ materially from those projected in this release.

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CONTACT: Novopharm Biotech Inc., Toronto Stacey Jurchison, 416/291-8888 ext. 5165

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