GNBT.OB

[stocks2watch2]

GNBT....Up in pre mkt.
Generex Biotechnology Granted United States Patent in Connection With Its RapidMist(TM) Device


http://biz.yahoo.com/iw/060105/0105335.html

[stocks2watch2]

Symbol: GNBT

Generex Biotechnology Announces Commencement of a Long-Term Oral-lyn(TM) Clinical Study in Juvenile Patients With Type-1 Diabetes

http://biz.yahoo.com/iw/060109/0105618.html

[stocks2watch2]

GNBT- approaching 1.00

Generex Biotechnology Announces Commencement of a New European Clinical Study of Oral-Lyn(TM) in Patients With Type-1 Diabetes.

http://biz.yahoo.com/iw/060110/0105747.html

[stocks2watch2]

Watch this one today.......
May be ready to rumble !!!! 

SETRAVIS, did you buy GNBT? It's up 22% since you posted this.
Bid-1.01
Ask-1.02
Volume-1,630,000

[GatewayStocks]

Generex Biotechnology Announces Commencement of a New European Clinical Study of Oral-Lyn(TM) in Patients With Type-1 Diabetes
Study Conclusions to Be Included in Regulatory Submissions to Demonstrate New Diabetes Treatment Paradigm
Generex Biotechnology Corporation (NASDAQ: GNBT), a leader in the area of buccal drug delivery, announced today that it has commenced a new European study of Oral-lyn, the Company's proprietary oral insulin spray product, in patients with Type-1 diabetes mellitus. The study, entitled "A 12-Week, Open-Label, Randomized, Active Comparator Study of Oral-lyn(TM) Spray and Injected Human Insulin in Patients with Type-1 Diabetes Mellitus," will be undertaken at The Department of Endocrinology and Diabetes at the University Campus Bio-Medico in Rome, Italy under the supervision of internationally renowned diabetes investigator Professor Paolo Pozzilli, MD.

The Diabetes Control and Complications Trial (DCCT) demonstrated that an improvement in blood glucose levels reduces the risk of long-term micro-vascular complications in patients with type-1 diabetes. However, the DCCT also demonstrated that intensive subcutaneous (injected) insulin therapy results in an increased frequency of hypoglycemia such that ideal blood glucose control is not achieved. In addition, for many patients, the idea of multiple or intensive insulin use is undesirable because of the pain and inconvenience associated with injections.

To a large extent, sub-optimal glucose control and the risk of hypoglycemia are a result of the pharmacokinetic properties of subcutaneously injected insulin. Insulin absorption is strongly affected by local factors such as the site of injection, the depth of injection, the temperature and permeability of the tissue, and whether the underlying muscle is exercising or not. Furthermore, the pharmacokinetics of insulin are affected by the amount of insulin given, with large doses resulting in delayed time to peak effect and longer duration of action.

Although new monomeric insulin analogues may result in a more rapid onset and a shorter duration of insulin action, no practical method has been found to control the multiple variables affecting injected insulin absorption. The inability of injected insulin administration to effectively, reproducibly, safely, and painlessly control postprandial glucose levels has motivated Generex's exploration of alternative methods of insulin delivery.

Generex has developed the RapidMist(TM) Diabetes Management System, which will be used to administer Oral-lyn. This system is based on a unique, proprietary formulation technology that provides a pain-free, needle-free, convenient method of administering insulin as a liquid pharmaceutical formulation delivered accurately into the mouth of the patient in the form of a spray. The fast-moving, fine particle aerosol easily traverses the thin membrane of the mucosal surface area of the oral cavity where it is absorbed into the blood stream and appears in the circulation within 10 minutes of the application of the spray. Oral-lyn(TM), as an Advanced Oral Drug Delivery platform, has a fundamental series of attributes: rapid access to the circulatory system; precise dosage control; simple self-administration procedure; and bolus drug delivery.

Previously published Phase 2 data from studies sponsored by Generex show that the speed of onset of the glucose-lowering response following Oral-lyn administration is consistent with that required for the achievement of postprandial glucose control. In particular, those studies demonstrated that Oral-lyn produces the desired rapid insulin uptake consistent that with required for dosing with a meal. Oral-lyn is a tasteless, liquid aerosol mist, which even after repeated administration, causes no irritation, burning, or discomfort in the mouth. In both long and short-term studies in patients with type-1 and type-2 diabetes undertaken in the USA, Canada, Europe, and South America, the onset of Oral-lyn action was earlier than that of subcutaneously injected insulin. Moreover, the studies demonstrated that Oral-lyn administration was successful in controlling postprandial glucose levels without relevant adverse events (no evidence of liver function changes, hematological changes, or severe hypoglycemia have been reported) and in the lowering of glycosylated hemoglobin (HbA1c) when compared to either standard subcutaneous injection therapy or oral agent therapy.

This new study of 60 adult patients with a history of type-1 diabetes mellitus in excess of one year and present intensive insulin therapy will evaluate the metabolic efficacy of Oral-lyn when administered at mealtimes in comparison to standard regular insulin therapy as measured by HbA1c. Following a baseline stabilization phase to determine optimal glargine and regular insulin doses, one group of patients will receive Oral-lyn in a split-dose fashion (half the dose immediately prior to the meal and the other half of the does immediately following the meal) at the optimal individualized dose. The other group of patients will receive regular insulin 30 minutes before meals and glargine insulin before the evening meal. All patients will remain on glargine therapy throughout the treatment period. Patients will consume regular meals and blood glucose levels will be measured four times each day (fasting level, before lunch, before dinner, and at bedtime).

About Generex

Generex is engaged in the research and development 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 (Oral-lyn(TM)), which has been approved for commercial sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world. Antigen Express 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 Web site at www.generex.com.

[setravis]

Watch this one today.......
May be ready to rumble !!!! 

SETRAVIS, did you buy GNBT? It's up 22% since you posted this.
Bid-1.01
Ask-1.02
Volume-1,630,000

I will get around to everything at some point in time....
Nice volume and price action.
Good luck with your trade ...... make some Greens!!!
Looks like it took a nice little bounce off the 200-dma.
Broke through the 50-dma. Let's Rock...

Technicals
Most Actives

Last Price Quote is:
16.27%above 13-day EMA
14.74%above 50-day EMA
RS Rating: 93 

Fundamentals
Key Data:
Market Cap (M): $55.27 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: N/A
Last Analyst Rating: Buy

[stocks2watch2]

Thanks for the update and chart.Looks like it's up 2% in pre mkt.

[setravis]

GENEREX BIOTECH CORP (NasdaqSC:GNBT) Delayed quote data 

Pre-Market (RT-ECN): 1.13  0.20 (+21.51%)


Yesterday's Closing Chart

[stocks2watch2]

Up 17% in pre mkt.

Generex Biotechnology Announces Pre-NDS Meeting Scheduled for Generex Oral-lyn(TM) With Health Canada

http://biz.yahoo.com/iw/060119/0106769.html

[stocks2watch2]

Google, Yahoo, Motorola, Intel, On2 Technologies, Apple Computer, Generex Biotech, International Securities Exchange, Food Technology Services, Animas Corp, StreetIQ.com; Wall Street to Main Street: News, Views and Commentary: January 20, 2006

Generex Biotechnology Corp Moves Forward

Generex Biotechnology Corp (NASDAQ: GNBT) shares took a nice leap in positive territory on Thursday after the Canadian drug delivery technology company said it will commence talks with Canadian regulators about filing for a form of oral insulin.

We profiled this company on "Wall Street to Main Street" and see more legroom for the company, their product could avoid millions of people from being subject to an injection on a consistent basis.

The stock jumped almost 12 percent to $1.05, the stock can break through it's 52 week high of $1,52 if this proves successful.

We will try to get on the phone with Generex Chief Ms. Anna E. Gluskin shortly to get more insight on the company.

[stocks2watch2]

GNBT-Up 26%
Generex to Meet With FDA on Bird Flu Drug
AP (Mon 9:07am) 

http://biz.yahoo.com/ap/060123/generex_bird_flu_vaccine.html?.v=1

[stocks2watch2]

Generex Biotechnology Announces Interim Results of Clinical Breast Cancer Trials

http://biz.yahoo.com/iw/060125/0107353.html

[GatewayStocks]

GNBT; Meets With FDA on Bird Flu Drug next week...Big buyers accumulating this week and early next week for FDA Human Testing

[GatewayStocks]

GNBT: Broke $1.29 resistance...Next resistance $1.36

[GatewayStocks]

GNBT FDA Meeting This Friday For bird flu Vaccine & Canadian meeting march 1st for Oral-lyn oral insulin spray.

===============================================
Generex to Meet With FDA on Bird Flu Drug
Monday January 23, 9:07 am ET 
Generex Sets Date to Meet With FDA to Discuss Human Studies of Bird Flu Vaccine; Shares Rise


NEW YORK (AP) -- Tiny drug developer Generex Biotechnology Corp. saw its shares shoot up 25 percent in premarket electronic trading Monday after regulators set a date to discuss potential human studies of its experimental bird flu vaccine.
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The Food and Drug Administration said it will meet with Generex on Feb. 10 to discuss what it will need to apply for approval and to begin human studies. The meeting is just one of the earliest stages of a usually lengthy process of clinical trials and data analysis, but worries about a potential bird flu pandemic have caused strong investor response to even earlier-stage bird flu vaccine candidates in recent months.

Shares of the Toronto-based firm jumped 25 cents, to $1.25 in premarket trading on the INET electronic exchange. The Nasdaq-listed stock closed Friday at $1 per share.

The bird flu strain targeted by Generex's Antigen Express vaccine has killed at least 80 people and decimated bird populations throughout Asia. Scientists have warned that it could mutate, becoming easily transmittable between humans.

Generex said its vaccine could be key in fighting the vaccine because it can be manufactured synthetically, making it less expensive to produce the vaccine and speeding up the process.
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Canada;
The company will meet with Health Canada's Biologics and Genetic Therapies Directorate to discuss applying for marketing clearance for its Oral-lyn oral insulin spray.