R.J Steffens

Big Pharma: Where's the Risk Management?

On Jul 07 06:58 PM upndown1313 wrote:

> Sorry not impressed, either with oral-Lyn data that has been presented or the concept of a metformin chewing gum. Based on PhII results, PhIII will not get approval fro Oral-Lyn.
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Recent Oral-lyn Phase II results:

ADA Scientific Sessions 2008 "Insulin Analogue (Basal + Pre-Prandial Injection) vs. Human Insulin (Basal Injection + Prandial Oral Insulin (Generex Oral-lyn™) in Type-1 Diabetes Mellitus: A 372-Day Comparison"

Conclusion: "A regimen consisting of basal BID s.c. NPH and prandial orally-absorbed regular insulin (Generex Oral-lyn™) attained lower pre-meal glucose, HbA1c and Fru concentrations, than a regimen using basal and pre-prandial insulin analogue injections in Type-1 DM during a 372-day period."

professional.diabetes....

ADA Scientific Sessions 2007 "Comparison of Pre-prandial s.c. Regular Insulin vs Prandial Oral Insulin (Oral-lyn) in Adult Type-1 DM Subjects Receiving Basal s.c. Twice Daily Isophane Insulin (NPH)"

Conclusion: "Near normalization of parameters of DM metabolic control was achieved in all subjects. Direct comparison of HbA1c concentrations during CP demonstrate a superior effect of Generex Oral-lyn™ over subcutaneously injected regular insulin."

professional.diabetes....

"It is not like the inhaled insulin, so it doesn't get into the lungs,” said study investigator Philip Raskin, MD, professor of medicine at The University of Texas Southwestern Medical Center in Dallas. “People seem to like it, and it does seem to lower the blood sugar [the way] it is supposed to.”

Dr. Raskin is among the researchers involved in an international phase 3 study of 750 patients.

www.renalandurologynew.../

Four Drug Companies Vying for Diabetes Patients

Hi GreenClay,

Generex has conducted dose-response studies on their buccal insulin spray. Their patented Rapidmist delivery device has been found to bring precision dosing where each spray measures approx 1 Unit- of Oral-lyn human insulin from the first spray to the last. This allows for tight titration and is one of the main positive features of Oral-lyn. If you email the company at generex.com, they can send you the published data from the peer review (I believe the report was dated 2005).

There are no pills or syrup this far along in Phase testing. Oramed and Biocon have pills that are in very early Phase IIa, and one has a pill whose dose measures 8 mg and the other measures 10 mg. Both have tested their pills in a small handful of patients. I have followed both, and Emisphere also has promising platform technology, but has had difficulties in translating their research into a successful pill form.

Exubera was also measured in mg, and not the unit that diabetics, such as yourself, are familiar with. Their dosing was confusing and one of the many reasons for its lack of success.

An effective oral one unit dose should make things easier to calculate, depending on weight and carbs per meal. The low dose aspect would be a negative if many units are required for certain Type 1's. It is interesting that Generex is set to begin a diabetes preventive trial for those that are pre-diabetic or at risk of developling diabetes. This is similar to TrialNet, and is an area to watch for future developments.

ADA's 68th Scientific Sessions: A New Look at Insulin Therapy

"the downtrend was not accompanied by any vlome to speak of, and that is the only are that is comforting. ;)"

I'll redo that one! LOL. I was watching the Yankee game and typing.

The downtrend was not accompanied by any substantial volume, and that is an area we may draw comfort. ;)

ADA's 68th Scientific Sessions: A New Look at Insulin Therapy

I think part of the problem has to do with the overall state of the market and how that has caused some problems for baby microcap biotechs such as Generex. All of the news coming from Generex has been positive- from new Phase II data for Oral-lyn regarding a one year and 372 day study in Type 1 diabetes to the positive AE37 results that were just published with the USMCI and Walter Reed in the Journal of Clinical Oncology.

If we look at what they are doing in the clinic, which is what is important, we see they have one Phase III (Oral-lyn) and one Phase II (AE37 in breast cancer) underway for drugs targeting diabetes and cancer. Metcontrol Gum will probably be an Abbreviated Submission and their next trial looks set to begin. The wholly owned subsidiary, Antigen Express, also has two Phase I's that are dosing and three other vaccines (AE37 Combo with/and funded by Mary Crowley Medical, the melanoma vaccine with the Mayo Clinic, and the RNAi/Ii-key with Dr. Daopei Lu in Beijing) getting ready for human trials. The HIV DNA vaccine could pop up sometime in late 2008.

But financing also occured a couple of months back that may have added 30 mm shares to the outstanding total, and we will see in the 10K (Oct 2009) what the current OS total equals. That may have augmented the woes seen in the market, because there appears to be no bad news associated with the company or stock. Pending early approvals in the Middle East or Asia (China) for Oral-lyn may sneak up and lift the stock, as well as any other positive developments that the company announces.

Oral-lyn was featured on FOX News Health segment this week with Generex's Dr. Gerald Bernstein (former pres of the ADA):

www.foxnews.com/video2.../

I don't think delisting is a concern, because there is too much positive action occuring in the pipeline. They have 180 days to regain compliance and that should offer them enough room for announcing the type of news that will generate investor confidence. the downtrend was not accompanied by any vlome to speak of, and that is the only are that is comforting. ;)

ADA's 68th Scientific Sessions: A New Look at Insulin Therapy

There was a link in a posted comment there to an article about the event that I was talking about as being well written. Now I don't see it. That's funny, but I guess I'll now take the compliment to myself. LOL.

ADA's 68th Scientific Sessions: A New Look at Insulin Therapy

Very well written and informative. I didn't see that much coverage of the event. This was a fresh perspective, and a fresh perspective also appears to be taking place in diabetic care.

Oncology Conference Countdown: What Will Pharma and Biotech Companies Report?

Hi Mike, great article and idea for investors of biotech and pharma oncology stocks. We know big pharma has been looking at small biotechs with promising cancer vaccines. Looks like this one of a Phase I study I found from ASCO 2008 is not only safe (no grade 3 toxicity cases), but is the first peptide vaccine to exhibit such positive immuno responses even WITHOUT an adjuvant:

Results of the first phase I clinical trial of the novel Ii-key hybrid preventive HER2/neu peptide (AE37) vaccine: United States Military Cancer Institute Clinical Trials Group Study I-03.
Sub-category: Vaccines
Category: Developmental Therapeutics: Immunotherapy
Meeting: 2008 ASCO Annual Meeting

"Results: All 15 patients completed the trial with no grade 3-5 local or systemic toxicities. Dose reductions occurred in 47% of patients for local reactions >100mm or grade 2 systemic toxicities. The second group (peptide=500mcg, GM-CSF=250mcg) all required dose reductions prompting peptide-only inoculations in the third group (peptide=1,000mcg, GM-CSF=0mcg). AE37, with and without GM-CSF, elicited dose-dependent immunologic responses in vitro and in vivo to both AE37 and AE36 albeit AE37 responses were more robust. Assessing both toxicities and immunologic responses, the hypothesized optimal biologic dose was determined as peptide=500mcg, GM-CSF=62.5mcg, in 6 monthly injections. Conclusions: The hybrid AE37 vaccine appears safe and well tolerated with minimal local or systemic toxicity if properly dosed. AE37 is capable of eliciting HER2/neu-specific immune responses, even without the use of an adjuvant.

This trial represents the first human experience with the Ii-Key modification, and to our knowledge, AE37 is the first peptide-based cancer vaccine to show potency in the absence of an immunoadjuvant."

www.abstract.asco.org/...

AE37 vaccine is from Antigen Express- a wholly owned subsidary of (GNBT) Generex. This is now in a large Phase II with the USMCI. What do you think?