[Diabetes-talk] FW: GNBT Announces

[catdancing]

i looked up that study for the oral insulin
it says it was started in April 2008 and completes in 2010
i wish them luck
Debbie
----- Original Message ----- 
From: "Ed Bryant" <ebryant at socket.net>
To: "Diabetes Talk" <diabetes-talk at nfbnet.org>
Sent: Friday, September 11, 2009 12:58 PM
Subject: [Diabetes-talk] FW: GNBT Announces


> Hi Folks,
>
> The FDA has approved a study of Oral-Insulin. I do not know when the study
> will begin but the following is what information I have.
>
> Regards,
>
> Ed Bryant
>
>
>
> From: Rose C. Perri [mailto:rperri at generex.com]
> Sent: Thursday, September 10, 2009 9:07 PM
> To: Rose C. Perri
> Subject: FW: GNBT Announces
>
>
>
>
>
> GENEREX ANNOUNCES USFDA APPROVAL OF USE OF COMPANY'S FLAGSHIP BUCCAL 
> INSULIN
> PRODUCT, GENEREX ORAL-LYNT, UNDER THE USFDA'S TREATMENT
>
> INVESTIGATIONAL NEW DRUG (IND) PROGRAM
>
>
>
> WORCESTER, MA, September 10, 2009 (GlobeNewswire) - Generex Biotechnology
> Corporation (Nasdaq: GNBT, www.generex.com), the leader in drug delivery 
> for
> metabolic diseases through the inner lining of the mouth, today announced
> that the U.S. Food and Drug Administration (FDA) has granted approval for
> the treatment use of Generex Oral-lynT under the FDA's Treatment
> Investigational New Drug (IND) program.
>
>
>
> The FDA's Treatment IND program allows companies to provide early access 
> to
> investigational drugs for patients with serious or life-threatening
> conditions for which there is no satisfactory alternative treatment. 
> Drugs
> that are granted approval by the FDA for the Treatment IND program must
> demonstrate the prospect of efficacy through clinical testing.
>
>
>
> Under a structured Treatment IND protocol, Generex Oral-lyn T will be
> provided to patients with serious or life-threatening Type 1 or Type 2
> diabetes mellitus, with no satisfactory alternative therapy available for
> the treatment of diabetes, and who are not eligible to participate in the
> Company's ongoing global Phase III pivotal clinical trial.
>
>
>
> This Treatment IND will be open to eligible patients that comply with the
> inclusion / exclusion criteria of the protocol, including those who are
> taking currently approved anti-diabetic medications.  There are no oral or
> injectable medications contraindicated for this IND program.
>
>
>
> In order to learn more about the availability of Generex Oral-lynT under 
> the
> IND Treatment program, as per FDA requirements, the Company will be
> providing information within the www.ClinicalTrials.gov
> <http://www.clinicaltrials.gov/>  website. Details will include study 
> design
> and participating sites and/or physicians.  Please note that the drug will
> be available only through physicians who are registered in the Treatment 
> IND
> program.
>
>
>
> "We are excited about having the opportunity to meet the needs of American
> patients living with diabetes who have no satisfactory alternative 
> treatment
> and have contacted the Company, based on their special needs, about 
> possible
> access to Generex Oral-lynT", stated Anna Gluskin, Generex's President and
> Chief Executive Officer.  "This opportunity to provide those in critical
> need of Generex Oral-lynT will continue while the pivotal Phase III study
> concludes and the Company prepares for its New Drug Submission with the
> USFDA and other major health authorities in key markets."
>
>
>
> About Generex Biotechnology Corporation
>
>
>
> 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 RapidMistT device.  The Company's flagship product, oral 
> insulin
> (Generex Oral-lynT), which is available for sale in India, Lebanon, 
> Algeria,
> and Ecuador for the treatment of subjects with Type-1 and Type-2 diabetes,
> is in Phase III clinical trials at several sites around the world. Antigen
> Express, Inc. is a wholly owned subsidiary of Generex.  The core platform
> technologies of Antigen Express comprise immunotherapeutics for the
> treatment of malignant, infectious, allergic, and autoimmune diseases. 
> For
> more information, visit the Generex website at www.generex.com
> <http://www.generex.com/>  or the Antigen Express website at
> www.antigenexpress.com <http://www.antigenexpress.com/> .
>
>
>
>
>
> Safe Harbor Statement
>
>
>
> This release and oral statements made from time to time by Generex
> representatives in respect of 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.
>
>
>
> Generex Contacts:
>
>
>
> Investor Relations Contact:
>
> American Capital Ventures, Inc.
> Howard Gostfrand
> 1-877-918-0774
>
> Media Contact:
> Beckerman Public Relations
> Angelene Taccini
> 201-488-0049
>
>
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