GNBT.OB

[stocks2watch2]

Generex Biotechnology Completes Positive Pre-NDS Meeting With Health Canada for Generex Oral-lyn(TM)
Friday March 3, 8:45 am ET


Company Now Has Clear Roadmap to NDS


TORONTO--(MARKET WIRE)--Mar 3, 2006 -- Generex Biotechnology Corporation (NasdaqSC:GNBT - News) announced today that on March 1, 2006 the Company concluded a positive Pre-New Drug Submission (NDS) meeting with the Regulatory Affairs Division of the Biologics and Genetic Therapeutics Directorate of Health Canada in respect of Generex Oral-lyn(TM), the Company's proprietary oral insulin spray product for the treatment of diabetes.



The purpose of the Pre-NDS meeting was to review the current status of Generex Oral-lyn(TM) with a view to determining what will be required for a successful New Drug Submission which will allow Generex Oral-lyn(TM) to be marketed and distributed in Canada.

"The informed and vigorous engagement of the Health Canada representatives in our meeting was most gratifying," said Anna Gluskin, Generex President & Chief Executive Officer. "We now have clearly defined objectives in a roadmap to a successful New Drug Submission for Generex Oral-lyn(TM) and we will move expeditiously to achieve those objectives and prepare the NDS." The NDS will include all clinical data, bio-statistical analyses, sample batches, chemistry, manufacturing and controls (CMC), production schedules, and medical device licensing."

The Company expects that the NDS documentary package, together with the April, 2005 approval of Generex Oral-lyn(TM) by the Ecuadorian Ministry of Public Health, will advance similar filings for regulatory approvals with the United States Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA).

[yabadabado]

Wow, what a ride from MBAY!!!  That was easy 4k profit in one hour.
Had to sell it to make a room for more of GNBT

It looks like it ended 4-day skid and reversal trend stating today.

If we close strong today, we will might see new 52 week high next week

Long GNBT to +$100 (my target price with Global Marketing Approval)

[stocks2watch2]

GNBT: Generex Biotechnology Announces Positive Preliminary Results in a Long-Term Clinical Trial of Generex Oral-lyn(TM) in Juvenile Patients With Type-1 Diabetes Mellitus

8:40am 03/08/2006

GNBT2.02, -0.22, -9.8%) , a leader in the area of buccal drug delivery, announced today positive preliminary results (10 weeks) of a long-term (six month) clinical trial of Generex Oral-lyn, the Company's proprietary oral insulin spray product, in juvenile patients with Type-1 diabetes mellitus (DM).
Generex previously reported the successful replacement, during a 12-day period, of subcutaneously (s.c.) injected pre-prandial regular insulin with Generex Oral-lyn in 10 adult patients with Type-1 DM. The objective of this new study is to document the effects of replacing the lunchtime dose of s.c. injected regular insulin with Generex Oral-lyn in juvenile type-1 DM patients. A comparison between the two different insulin preparations was done initially (3-4 weeks), followed by a six month replacement period with Generex Oral-Lyn at lunchtime. The results of the first ten weeks of the trial are referenced here. As in the previous study, this new study involves a Generex Oral-lyn split-dose treatment, i.e. the application of Generex Oral-lyn spray both before and after each meal. Generex believes that this approach offers a new diabetes treatment paradigm by offering improved efficacy (as Generex Oral-lyn is better at mimicking the healthy body's natural insulin production) and patient compliance (no painful injections) resulting in greater metabolic stability thereby better controlling diabetes and reducing the complications associated with it. Treatment of adolescents with Type-1 DM is challenging and Generex chose to replace the lunchtime dose because it is this dose that is most frequently associated with non-compliance.
This new study is taking place at the Institute of Endocrinology IEMYR in Quito, Ecuador, under the supervision of Dr. Jaime Guevara-Aguirre M.D., the principal Investigator of the study. All of the participants in the study were referred to IEMYR for treatment. The participants are: (a) 24 adolescents (12 males, 12 females) with a mean age of 14.7 years and a mean Body Mass Index (BMI) of 21.7, and (b) five young adults (two males, three females) with a mean age of 20.6 years and a mean BMI of 23.0. The mean age of the entire participant group is 15.7 years and the mean duration of the diabetes mellitus is 6.8 years.
Because the study participants were referred to IEMYR in varying states of diabetic control, it was necessary to metabolically stabilize them using standardized therapy prior to the commencement of the study. Upon referral to IEMYR, each participant received a schedule of baseline insulin glargine in addition to thrice-daily pre-prandial injections of regular insulin. Metabolic stability was achieved by intense monitoring of glucose levels, adjustments to the insulin schedule, and implementation of proper dietary measures. Glucose was monitored frequently (six-point glucose daily profiles for 20 days). Fructosamine and glycosylated hemoglobin (HbA1c) were obtained at the commencement of the stabilization program and after 20 days.
The 29 subjects (2 new subjects were incorporated shortly after the commencement of the study) were metabolically stabilized in a very short period of time (20 days) as documented by important and statistically significant improvements in the six-point daily glucose profiles (p < 0.0005), as well as in protein glycosylation parameters: Fructosamine (p < 0.0001), and HbA1c (p < 0.0001). The decrement in the last two parameters displayed strong correlation. These results were attributed to the improvement in previous insulin schedules, enhanced nutritional advice, and intense glucose monitoring.
After stabilization and an initial four weeks with regular insulin at lunchtime, Generex Oral-lyn replaced the lunchtime injected insulin. The following 10-week results were obtained:

[stocks2watch2]

I think marketwatch needs to correct their error LOL


Symbol: GNBT

[ GNBT ] Generex Biotechnology up 7.1% at $68.80
By  MarketWatch
3/8/2006 09:38:07 AM

[setravis]

Hot...Hot...Hot ! 

Will get even hotter...
Long term buy along with GNTA.
I've already made gains in both, and feel that there is much room for even more gains.IMHO..

Donald Luskin has this marked one as a bird flu play and it looks to be in a nice uptrend. Loose stop on this one, The pullback is probably a nice entry.

Support @ $2.04...1.92...1.80
Resistance @ $2.27...2.42...2.57

Volume: 7,966,056
Avg Volume (3m): 5,836,150

Recent CandleStick Analysis
Very Bullish
Mar-08-2006 Homing Pigeon 

Technicals
Close Above the 13-day EMA
Most Actives
MACD is Bullish

Last Price Quote is:
3.88%above 13-day EMA
39.45%above 50-day EMA
RS Rating: 98 

Fundamentals
Key Data:
Market Cap (M): $147.40 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: N/A
Last Analyst Rating: Buy

[stocks2watch2]

Generex Biotechnology to Present Its Avian Influenza Vaccine Program at DNA Forum in London, 8:30 AM ET Mar 14, 2006


TORONTO, Mar 14, 2006 (MARKET WIRE via COMTEX) -- Generex Biotechnology Corporation (GNBT : generex biotechnology
GNBT2.18, -0.02, -0.9%) announced today that Dr. Douglas Powell, Ph.D., Director of Immunobiology at Antigen Express, Inc., the Company's wholly owned immunotherapeutics subsidiary, will present the Antigen Express H5N1 avian influenza vaccine program at the upcoming Third Annual DNA Vaccines Forum to be held in London, UK, March 17 - 18, 2006.
The strategy employed by Antigen Express focusing on the development of its novel H5N1 avian influenza vaccine utilizes small portions of the H5 protein that are modified to enhance antigen-specific stimulation of T-helper cells. Upon infection, such T-helper cell responses enhance the speed and strength of neutralizing antibody production. It is anticipated that the vaccine being developed will both impart some level of protection on its own and enhance the activity of other types of avian influenza vaccines, including DNA vaccines.
The meeting will focus on the latest advances involving DNA vaccine technology as well as clinical experiences and regulatory issues. All vaccines that are currently approved for human use are inactivated or attenuated (weakened) viruses or recombinant protein vaccines. DNA vaccines are a promising new approach with the potential to prevent many infectious diseases such as H5N1 influenza, anthrax and plague. Although a number of DNA vaccines are currently in clinical trials, none have been approved for use in humans. One of the challenges facing the use of DNA vaccines is that the responses generated in humans may be insufficient to prevent infection. To address this issue, scientists have investigated numerous methods to enhance the immunogenicity of DNA vaccines including the use of novel adjuvants and cytokines. For many diseases, including influenza, the generation of neutralizing antibodies produced by B lymphocytes is sufficient to protect against infection. The CD4 T cell response is essential for generating high levels of neutralizing antibodies in addition to eliciting memory T and B cell responses that provide protection against future infections. CD4 T cells recognize MHC class II epitopes presented on the surface of antigen presenting cells. Dr. Douglas Powell and Dr. John Zinckgraf at Antigen Express have demonstrated that immunization of mice with MHC class II epitopes derived from the H5N1 influenza hemagglutinin protein coupled to the proprietary Ii-Key peptide greatly enhances the CD4 T cell responses to a DNA vaccine encoding the H5N1 influenza hemagglutinin protein and may be used as a strategy to increase the immunogenicity of DNA vaccines.
One of the major challenges facing immunization with many of the currently available vaccines is the need for refrigeration, often referred to as maintenance of the cold chain. This is a particularly difficult problem in developing countries with limited medical resources. One of the advantages of a vaccine utilizing peptides and DNA is that both of these components can be lyophilized, stored at ambient temperatures and reconstituted "on-site" with saline. "We have promising data in an animal model suggesting that we will be able to achieve levels of immunity consistent with protection from H5N1," said Dr. Powell. The company has recently completed a pre-IND meeting with the FDA and hopes to enter human clinical trials of its peptide vaccine against H5N1 later this year.

[stocks2watch2]

Generex Biotechnology Announces Additional Preliminary Results in a Trial of Generex Oral-lyn


TORONTO, Mar 15, 2006 (MARKET WIRE via COMTEX) -- Generex Biotechnology Corporation (GNBT : generex biotechnology cp del com

GNBT2.31, +0.13, +6.0%) , a leader in the area of buccal drug delivery, announced today additional preliminary results (10 weeks) of a long-term (six month) clinical trial of Generex Oral-lyn, the Company's proprietary oral insulin spray product, in adolescent and young adult patients with Type-1 diabetes mellitus. This data, which complements the positive data announced by the Company on March 8, 2006, shows the variations of glycosylated hemoglobin (HbA1c), a very well-known marker for monitoring diabetes, during the first 10 weeks of the study.
Glycosylated hemoglobin (HbA1c) is considered by regulatory agencies and endocrinologists as the best long-term measure of metabolic control of diabetes. "HbA1c correlates with the level of risk for diabetes complications," said Dr. Gerald Bernstein, the Company's Vice-President for Medical Affairs. "The continuous and dramatic reduction seen in these preliminary results bode well for patients with diabetes, and society generally, in reducing the burdens of diabetes and its complications."
The investigators concluded that, during the first 10 weeks of this ongoing six-month trial, replacement of subcutaneous injections of regular insulin by Generex Oral-lyn at lunchtime in adolescent and young adult patients with Type-1 diabetes was associated with overall adequate glycemic control and similar glycosylated hemoglobin (HbA1c) concentrations.

[setravis]

Nearing Insulin spray...

Volume: 11,971,300
Avg Vol (3m): 6,371,100


Technicals
Most Actives
Gap Up

Last Price Quote is:
12.02%above 13-day EMA
45.34%above 50-day EMA
RS Rating: 99 

Fundamentals
Key Data:
Market Cap (M): $139.77 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: N/A
Last Analyst Rating: Buy

[stocks2watch2]

TORONTO, Mar 16, 2006 (MARKET WIRE via COMTEX) -- Generex Biotechnology Corporation (GNBT
9:31am 03/16/2006

GNBT2.46, +0.07, +2.9%) , a leader in the area of buccal drug delivery, announced today that it has been granted a patent by the Mexico National Registry of Patents titled "Proteinic Drug Delivery System Using Aerosolized Membrane-Mimetic Amphiphiles." The patent, an extant United States Patent registered by the Company, relates to an improved delivery system for the administration of large-molecule pharmaceuticals, particularly through the oral and nasal membranes.
The patent covers formulations for the delivery of peptidic drugs, vaccines, and hormones and enhances the Company's existing drug delivery platform patent portfolio.
"We are pleased to augment our Latin American patent protection as we continue with our Generex Oral-lyn(TM) commercialization efforts in the region," said Rose Perri, the Company's Chief Operating Officer. Generex Oral-lyn is the Company's flagship product, a proprietary oral insulin spray product which has been approved by the Ecuadorian Ministry of Public Health for the treatment of Type-1 and Type-2 diabetes.
The Company currently holds an aggregate of 71 patents (19 of which are United States patents) and has an aggregate 58 patent applications pending in various jurisdictions.

[Holygrale]

I'm in, this looks strong...........

[mexirafa]

Hello Holygrale,

Would 2.40 be a good stop or 2.01 to be in the safe side in case of a retracement?

thanks,
rafael

[dez]

Mexirafa

2.40 is a good stop.  However this stock is displaying a G-Pattern. 

The last G-Pattern ran 1.35 cents from 1.40 to 2.75 before a correction back to 2.00
A repeat price pattern would take it to 3.75 with only minor 10 and 20 cent pull backs along the way.

I feel this is a special situation where the stock may be on the verge of a mania price run due to the media hype, factual reports of infected birds from around the globe and Oral Insulin gaining widespread acceptance for Diabetics.  As you know there was a PR Newswire report today concerning Mexico.

Volume was heavy today and the after hours price did not waver one iota. And right now this news has been released from Russia:

30,000 bird-flu deaths in south Russia in last 24 hours - ministry
10:25 | 16/ 03/ 2006
Print version

ROSTOV-ON-DON, March 16 (RIA Novosti, Sergei Rudkovsky) - More than 30,000 birds have died of bird flu in southern Russia over the last 24 hours, a local emergencies ministry official said Thursday.

"In Krasnodar Territory, 21,912 chickens have died over the last 24 hours, and the total number of dead birds has reached 350,288," the official said.

A further 10,818 birds have died over the last 242 hours in the North Caucasus republic of Daghestan, the official said, bringing the total including culled birds to 760,000.

A third wave of bird flu struck Russia starting February 3. The country's southern regions, where all cases in the country have so far been registered, are particularly vulnerable as a stopover for migrating birds. A vaccination program is currently underway in many of the country's regions.

No human deaths from bird flu have so far been registered in Russia.

Tomorrow looks promising.  This may be worthy of consideration for the 3SOF Porfolio.

[Holygrale]

Mexirafa, Dez is right on.

Personally, I stopped using stop losses years ago. So with that said, if your willing to go down as far as $2.01 then use $2.30 instead. Just in case it back fills the gap at $2.36......

The problem with stop losses is that they take you out of the game in the event it reverses back up. This is why using menatal stop losses work better, you just have to be on the trigger that day as it approaches $2.36.................IMHO

[stocks2watch2]

Mexirafa, Dez is right on.

Personally, I stopped using stop losses years ago. So with that said, if your willing to go down as far as $2.01 then use $2.30 instead. Just in case it back fills the gap at $2.36......

The problem with stop losses is that they take you out of the game in the event it reverses back up. This is why using menatal stop losses work better, you just have to be on the trigger that day as it approaches $2.36.................IMHO

Exactly,never use a stop loss. When you own a volital stock never leave it unattended. I think we will make a run to 3.00 today, I'll be selling some more 2000 lots into the run. I think we'll see a sell off soon, before going up again. Resistance is 2.84, support is 2.35.

[stocks2watch2]

Well we broke through that 2.84 Now lets get over 3.00 so I can sell 20000 shares.