GNBT - Generex Biotechnology Corp. (NASDAQ Stock)

[Aufan 1983]

In at 1.15 and looking to add a few on some dips. At this point I'm only in for 200 shares.

This stock looks like most other pharm. plays and it will all depend on the studies and the FDA.

Here is the latest news:

Generex Biotechnology Announces North American Initiation of Generex Oral-lyn Phase III Diabetes Study
Monday April 7, 9:30 am ET
Patient Screening Underway in North America for the Company's Non-Injectable Insulin That is Absorbed in the Lining of the Mouth and Does Not Enter the Lungs


WORCESTER, Mass., April 7, 2008 (PRIME NEWSWIRE) -- Generex Biotechnology Corporation (NasdaqCM:GNBT - News), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced today that it has initiated the Phase III protocol in North America for its proprietary buccally-absorbed oral insulin spray product, Generex Oral-lyn(tm), with the commencement of patient screening. The first screening took place in late March in Texas. Other clinical sites participating in the study located in the United States are in Texas, Maryland, Minnesota and California, and in Canada in the province of Alberta.
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The Phase III protocol, identified as GEN084-OL, calls for a six month trial which is expected to include 750 patients with Type-1 diabetes mellitus. The primary objective of the study is to compare the efficacy of Generex Oral-lyn and the RapidMist(tm) Diabetes Management System with that of standard regular injectable insulin therapy as measured by Hba1c in patients with Type-1 diabetes mellitus. Generex Oral-lyn is delivered into the mouth via the Company's proprietary RapidMist device. Unlike inhaled insulin products, buccally-absorbed Generex Oral-lyn does not enter the lungs.

``This clinical milestone represents a long history of research and development to optimization for Generex Oral-lyn which is now entering the final clinical stage in major jurisdictions,'' said George Markus, the Company's Vice President of Regulatory Affairs. ``Our product is designed to offer a safe and convenient alternative to prandial insulin injections which can improve treatment compliance and quality of life for patients with diabetes.''

Generex Oral-lyn is presently approved for commercial sale in India and Ecuador. The delivery of Generex Oral-lyn clinical supplies to global sites and centers, including Ukraine and Russia, is on-going with roll-out to other regions to follow.

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 http://www.generex.com.

The Generex Biotechnology Corp. logo is available at http://www.primenewswire.com/newsroom/prs/?pkgid=3831

[Aufan 1983]

I may not be adding. Premarket is going up huge......

[Aufan 1983]

Now @ 1.40 premarket.

[Aufan 1983]

Looking good!!! Added 300 more @ 1.32

Thinking of selling another stock to get this to 1000 shares

[greencat]

GNBT is rebounding and looks like it wants to take out the last high. preliminary DD looks good.

Home Page: :: Generex Biotechnology Corporation ::

Investor Relations

Howard Gofstrand
Tel: (305) 918-7000
Fax: (305) 466-1747
Email: hg@amcapventures.com

Corporate Contact

Generex Biotechnology Corporation
33 Harbour Square, Suite 202
Toronto, Ontario, Canada M5J 2G2
Phone: (416) 364-2551
Fax: (416) 364-9363
E-mail: info@generex.com

SEC Filings

:: Generex Biotechnology Corporation ::

About Generex Biotechnology Corporation (GNBT:NAS).

Generex Biotechnology Corporation is the leader in drug delivery for metabolic diseases through the inner lining of the mouth and in the research and development of novel immunomedicines.

We continue to develop our own products as well as collaborate with pharmaceutical companies to apply RapidMist™ and the immunomedicines platform technology to their proprietary compounds and drug discovery pipelines. Similarly, we will continue to seek licensing, partnership and acquisition opportunities that complement our core capabilities in drug delivery technologies immunomedicines platforms.

We plan to advance our drug candidates into early clinical development prior to establishing partnerships for further development and commercialization. We will focus our efforts on compounds with known efficacy, which will result in a reduction of time and risk, and therefore the cost of developing drugs.

Our executive and administrative offices are located in downtown Toronto.

In December 2000 we opened expanded laboratory facilities, also in downtown Toronto, and we're currently completing work on a pilot manufacturing facility in the same commercial complex. We are now well positioned to conduct additional research and development on various large-molecule applications for our platform technology, and to produce our oral insulin formulation at the levels necessary for completing late-stage clinical trials. We have applied for and are awaiting regulatory approval for these new facilities.

To prepare for larger-scale manufacturing capacity, we've purchased two additional facilities, both within 25 miles of downtown Toronto. We anticipate that these facilities could be readied for production with twelve to eighteen months of lead-time when the need arises.

GNBT Management

Anna E. Gluskin
Chairman, President, CEO

Ms. Gluskin has held this senior position with Generex since its inception. Within this capacity, Ms. Gluskin plans, co-ordinates and manages the business activities and provides technical leadership throughout the Generex's product programs. Much of Ms. Gluskin's time is spent seeking new opportunities where Generex's platform technology may effectively be utilized. Ms. Gluskin holds a Masters degree in Microbiology and Genetics from Moscow State University

Rose C. Perri
Chief Financial Officer, COO, Treasurer, Sec., Director

Ms. Perri has an extensive background in management and operations. Since 1995, she has been responsible for managing the Generex's day-to-day operations, focusing her efforts on fiscal planning and budgeting. Ms. Perri holds a Bachelor of Arts degree from the University of Toronto and has completed the Business Administration Studies program at York University.

Mark Fletcher
Executive Vice President, General Counsel

An expert in corporate, commercial and securities law, Mr. Fletcher maintains a diverse practice that includes mergers & acquisitions and public and private equity and debt financings. He has represented public and private companies, including NASDAQ companies, investment banks and pension funds. His clients include health services and biotechnology companies as well as software/technology and construction firms. Mr. Fletcher received his LL.B. from the University of Western Ontario in 1989 and was admitted to the Ontario Bar in 1991. He is a member of the Law Society of Upper Canada and the Canadian Bar Association.

Dr. Gerald Bernstein, M.D.
Vice President, Medical Affairs, Director

Dr. Bernstein, M.D., F.A.C.P. graduated from Dartmouth College and Tufts University School of Medicine. He is board certified in internal medicine (1966) and endocrinology and metabolism (1973). Dr. Bernstein is an associate clinical professor at the Albert Einstein College of Medicine in New York. He is an attending physician at Beth Israel Medical Center, and physician emeritus at Lenox Hill Hospital and Montefiore Medical Center, all in New York. He was formerly Director of the Beth Israel Health Care Systems Diabetes Management Program. Dr. Bernstein was president of the American Diabetes Association in 1998-99 and was for many years a member of the ADA's Board of Directors and its Executive Committee. He received the ADA's Banting Medal for Service in 1999. Dr. Bernstein presently serves on several ADA committees and on the Board of Directors of the American Diabetes Association Research Foundation.

Dr. Eric von Hofe, Ph.D.
Vice-President of Generex and President of Antigen Express

Dr. Eric von Hofe, has been President of Antigen Express since April 2005. He joined Antigen in November 2003 as Vice President of Technology Development of Antigen. He has extensive experience with technology development projects, including his previous positions at Millennium Pharmaceuticals first as Program Director for Target Validation and later as Director of Programs & Operations, Discovery Research. Prior to that, Dr. von Hofe was Director, New Targets at Hybridon, Inc., where he coordinated in-house and collaborative research that critically validated gene targets for novel antisense medicines. Dr. von Hofe also held the position of Assistant Professor of Pharmacology at the University of Massachusetts Medical School, where he received a National Cancer Institute Career Development Award for defining mechanisms by which alkylating carcinogens create cancers. He received his Ph.D. from the University of Southern California in Experimental Pathology and was a postdoctoral fellow at both the University of Zurich and Harvard School of Public Health. His work has been published in twenty-eight articles in peer-reviewed journals, and he has been an inventor on four patents.

William D. Abajian
Senior Executive Advisor, Global Strategic Alliances & Business Development

Mr. Abajian has served in Senior Management and Executive positions throughout the past twenty-five years where he played pivotal roles in the development and launches of a number of pharmaceutical and device products. In 1988 he founded CPG Inc. in Lincoln Park, New Jersey where he served as Chief Executive Officer until 2002. CPG Inc. invented, manufactured and sold DNA Synthesis products, chromatography media’s and molecular biology kits to researchers in over 40 countries worldwide. This privately-held company was sold to Millipore Corporation in 2002. Prior to running his own company Mr. Abajian served as the Vice President of Sales and Marketing at Electro Nucleonics Inc. in Fairfield, New Jersey between 1981 and 1988. Electro Nucleonics Inc. invented, manufactured and sold blood chemistry systems and diagnostic kits worldwide. The company also launched the first FDA approved AIDS test. At Electro Nucleonics Mr. Abajian was responsible for procuring $50 million of hospital instrumentation sales, opened up the veterinarian market for the company and was key to brokering a deal that required all Armed Forces and The American Red Cross to purchase all HIV tests from the company. The organization included five regional managers, 45 sales representatives and 20 technical representatives. In 2004, he founded The Abajian Group LLC, a company that advises CEOs on strategic planning and assists in the commercialization of technologies and sales and marketing. He continues to serve as a trustee of Eva’s Village, a non-for-profit organization in Paterson, New Jersey, and of St. Joseph’s Hospital in Paterson, New Jersey, where he previously held the positions of Chairman of the OPEC Committee and a member of the hospital’s Finance and Pension Committee and the Executive Committee.

News

:: Generex Biotechnology Corporation ::

Chart and Stock Information

Share Structure

Outstanding Shares
111,478,091 as of Mar 6, 2008

[Aufan 1983]

Wow Generex had news below yesterday and the run continues today

Not in sold long ago for a loss but I should have bought yesterday when I saw the news.........

************************************************** ************************************************** ***************


Generex Biotechnology Announces Successful Phase III Study Data for Generex Oral-lyn(tm)
Tuesday March 10, 2009, 9:30 am EDT
Buzz up! Print Related:Generex Biotechnology Corp.
WORCESTER, Mass., March 10, 2009 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (NasdaqCM:GNBT - News) (:: Generex Biotechnology Corporation ::), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced positive results following the review of the Phase III data for the Company's flagship product, Generex Oral-lyn, a proprietary oral insulin spray product designed to replace prandial injections of insulin.

Related Quotes
Symbol Price Change
GNBT 0.46 +0.18


{"s" : "gnbt","k" : "c10,l10,p20,t10","o" : "","j" : ""} Generex, together with the Company's independent third party statistical and data monitoring consultants, will continue to monitor the ongoing pivotal Phase III Generex Oral-lyn study according to protocol and national/international ICH-GCPs. To date, more than 300 subjects have been enrolled in the study (with 60 subjects having achieved the requisite six-month treatment milestone) and the product's non-inferiority to injectable meal-time (prandial) insulin appears to be maintained. If the current positive trend is maintained, then a large reduction of required enrollment will suffice for formal verification of the non-inferiority hypothesis.

The current data also demonstrates that no significant Generex Oral-lyn drug-related ``Adverse Events'' or ``Serious Adverse Events'' have been reported, which also supports the current initiatives of the study.

``The current data and trends represent a critical milestone for the Company,'' said Anna Gluskin, Generex's President and Chief Executive Officer. ``These results are consistent with the results of our previous studies. This will allow us greater flexibility in our strategies for filing submissions with regulatory authorities in major global markets and other jurisdictions where applications are already in progress.''

The Company believes that Generex Oral-lyn will offer a safe, simple, fast, effective and pain-free alternative to prandial insulin injections which will improve patient compliance with therapeutic regimes thereby delaying the progress of diabetes and the onset of its myriad complications.

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 RapidMist(tm) device. The Company's flagship product, oral insulin (Generex Oral-lyn(tm)), which is available for sale in India 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. For more information, visit the Generex website at :: Generex Biotechnology Corporation ::.

The Generex Biotechnology Corp. logo is available at GlobeNewswire, Inc.

[Aufan 1983]

Just jumped in after seeing the news released today.




Generex Biotechnology Provides Update On Generex Oral-lyn(tm) in India
Indian Licensee Secures Over 100 Orders in First Month of Marketing
Wednesday March 11, 2009, 9:30 am EDT
Buzz up! Print Related:Generex Biotechnology Corp.
WORCESTER, Mass., March 11, 2009 (GLOBE NEWSWIRE) -- On the heels of yesterday's announcement of positive study data from its Phase III protocol for its flagship product Generex Oral-lyn(tm), Generex Biotechnology Corporation (NasdaqCM:GNBT - News) (:: Generex Biotechnology Corporation ::), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today provided an update on Generex Oral-lyn(tm) sales in India, where the product is marketed and sold by Shreya Life Sciences Pvt. Ltd. (http://www.shreya.co.in).

Related Quotes
Symbol Price Change
GNBT 0.46 +0.18


{"s" : "gnbt","k" : "c10,l10,p20,t10","o" : "","j" : ""} Generex Oral-lyn(tm) was approved in India for importation, commercial marketing and sale for the treatment of Type 1 and Type 2 diabetes and has been marketed under the brand name Oral Recosulin(tm) since January 27, 2009 in Mumbai and in the cities of Bangalore, Delhi, Kolkata, Chennai and Cochin since February 3, 2009. Sales managers at Shreya Life Sciences, along with key Shreya marketing and medical personnel, have been actively involved in promoting the product to key opinion leaders and physicians in the region.

Following the initial marketing campaign, Shreya Life Sciences has to date procured Oral Recosulin(tm) orders from more than 60 doctors for over 100 patients.

``We believe that the rapid progress that our licensee has made in India reflects the demand for a pain-free insulin product,'' said Anna Gluskin, Generex's President and Chief Executive Officer. ``Since the educational introduction of Generex Oral-lyn(tm) in India last November, Shreya has designed and implemented a strategy to identify target markets in India and establish an initial customer base from which we expect sales to continue to grow.''

Generex Oral-lyn(tm) is designed to offer a simple, convenient, fast, effective, flexible, familiar and pain-free alternative to prandial injections of insulin. Generex Oral-lyn(tm) is a proprietary oral insulin spray product, the first non-injectable buccal insulin approved in India. Unlike inhaled insulin products, buccally absorbed Generex Oral-lyn(tm) does not have pulmonary side effects, and is safely and efficiently delivered without pain via Generex's proprietary RapidMist(tm) device, which looks like a simple asthma inhaler, but provides complete absorption through the buccal mucosa (lining of the mouth) with no deposit in the lungs.

[Aufan 1983]

From the 10Q released this afternoon. For the entire filing hit the link but the following is what got my attention.



Summary of GENEREX BIOTECHNOLOGY CORP - Yahoo! Finance





Using our buccal delivery technology, we also have launched a line of over-the-counter glucose and energy sprays , including Glucose RapidSpray�, GlucoBreak�, and BaBOOM!� Energy Spray. We believe these products will complement Generex Oral-lyn� and may provide us with an additional revenue stream prior to the commercialization of Generex Oral-lyn� in other major jurisdictions.

In early November 2008, we submitted our product dossier to the Ministry of Health in Damascus, Syria through Generex MENA, our branch office in Dubai. The dossier includes Generex Oral-lyn�. We also submitted a file to register our proprietary over-the-counter products, including Glucose RapidSpray�, 7-Day Diet Aid Spray� (marketed as Crave-Nx� in the United States and Canada) and BaBOOM!� Energy Spray. The Syrian Ministry of Health will review the dossier and inform us of any additional requests for information that it may have. There have been no immediate queries, and we anticipate registration before the end of calendar year 2009. It is estimated that among Syria's population of 20 million, between 3 million and 3.5 million people have diabetes.

In December 2008, we submitted Generex Oral-lyn� dossier to the Ministry of Health in Iraq (North) through Generex MENA, our branch office in Dubai and expect to receive an approval to market the product in spring of 2009.

In October 2008, we announced the enrollment of subjects in our bioequivalence clinical trial of MetControl�, our proprietary Metformin medicinal chewing gum product. The protocol for the study is an open-label, two-treatment, two-period, randomized, crossover study comparing MetControl� and immediate release Metformin� tablets in healthy volunteers. The study results, that we received and analyzed in December 2008, will allow us to proceed with additional research and development initiatives and consider regulatory agency registration applications.

Our subsidiary, Antigen, concentrates on developing proprietary vaccine formulations that work by stimulating the immune system to either attack offending agents (i.e., cancer cells, bacteria, and viruses) or to stop attacking benign elements (i.e., self proteins and allergens). Our immunomedicine products are based on two platform technologies and are in the early stages of development. We continue clinical development of Antigen's synthetic peptide vaccines designed to stimulate a potent and specific immune response against tumors expressing the HER-2/neu oncogene for patients with HER-2/neu positive breast cancer in a Phase II clinical trial and patients with prostate cancer and against avian influenza in two Phase I trials. Development efforts also are underway for seasonal influenza virus, HIV, HPV, melanoma, ovarian cancer, allergy and Type I diabetes mellitus. We have established collaborations with clinical investigators at academic centers to advance these technologies.

We face competition from other providers of alternate forms of insulin. Some of our most significant competitors, Pfizer, Eli Lilly, and Novo Nordisk, recently announced that they will discontinue development and/or sale of their inhalable forms of insulin. Generex Oral-lyn� is not an inhaled insulin; rather, it is a buccally absorbed formulation with no residual pulmonary deposition. We believe that our buccal delivery technology offers several advantages over inhaled insulin, including the avoidance of pulmonary inhalation, which requires frequent physician monitoring, ease of use and portability.
We are a development stage company. From inception through the end of the year ended July 31, 2008, we have received only limited revenues from operations. In the fiscal year ended July 31, 2008, we received approximately $128,039 in revenues from sales of Glucose RapidSpray�. In the fiscal quarter ended January 31, 2009, we received approximately $435,078 in revenues from sales of Glucose RapidSpray�. These numbers do not reflect deferred sales to the customers during the respective period with the right of return.

We operate in only one segment: the research, development and commercialization of drug delivery systems and technologies for metabolic and immunological diseases.

We were incorporated in the State of Delaware in 1997. Our principal executive offices are located at 33 Harbour Square, Suite 202, Toronto, Canada, and our telephone number at that address is (416) 364-2551. We maintain an Internet website at :: Generex Biotechnology Corporation ::. We make available free of charge on or through our website our filings with the SEC.

[mart0593]

this went nuts today and is going crazy after hours.... i wonder what tomorrow will bring.

[mart0593]

there could be some positive news this morning.... .79-.75 premarket.