[Diabetes-talk] FW: GNBT Announces

[Ed Bryant]

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