Generex Biotechnology Receives Regulatory Approval to Initiate Phase III Clinical Trial for Generex Oral-lyn in First of the Global Locations Selected by the Company
Ministry of Health of the Ukraine Approves Phase III Protocol GEN084-OL for a Number of Clinical Sites in the Ukraine
WORCESTER, Mass., Jan 23, 2008 (PrimeNewswire via COMTEX News Network) -- Generex Biotechnology Corporation (Nasdaq:GNBT), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced that on January 22, 2008 the Ministry of Health of the Ukraine issued an approval letter for the conduct of a Phase III clinical trial protocol for Generex Oral-lyn(tm) at eight clinical sites located in the Ukraine. The significance of this approval is that it represents initiation of the first clinical sites for the pivotal study and permits commencement of screening for suitable patients. This approval is the first of seven countries within which the Company will be conducting the Phase III trial of Generex Oral-lyn.
The protocol calls for a trial with a six month active treatment period and a six month follow up which is expected to include up to 750 patients with Type-1 diabetes mellitus worldwide. The Company has already received non-objection letters from both Health Canada and the FDA to conduct this pivotal study. The primary objective of the study is to compare the efficacy of Generex Oral-lyn and the Company's RapidMist(tm) Diabetes Management System with that of standard regular injectable human insulin therapy as measured by Hba1c in patients with Type-1 diabetes mellitus.
"We are excited to initiate the first of our global Phase III centers for our flagship product," said Anna Gluskin, the Company's President & Chief Executive Officer. "After months of preparation and particular attention to detail and refining the protocol, the Company's plans for this pivotal study are starting to become a reality and we look forward to rolling out all the other clinical centers."
OSMOS Clinical Research, Inc. (www.osmos.us) of San Francisco, California, which is assisting Generex with global project management, together with PSI-CRO AG, which is responsible for implementation of the trial activities in Eastern Europe, Canada and USA, will spearhead the initiation of the centers and we expect patient enrollment to start very soon.
About Generex
Generex is engaged in the research, development, and commercialization of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist(tm) device. The Company's flagship product, oral insulin (Generex Oral-lyn(tm)), which is available for sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes and which was approved for sale in India in October 2007, is in various stages of clinical development around the world. For more information, visit the Generex website at www.generex.com.
Safe Harbor Statement: This release and oral statements made from time to time by Generex representatives concerning the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
This news release was distributed by PrimeNewswire, www.primenewswire.com
SOURCE: Generex Biotechnology Corp.
CEOcast, Inc.
Gary Nash
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For Generex:
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Howard Gofstrand
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