Review of Clinical Trials of Oral Insulin: Oral-lyn

This press release is an announcement submitted by Generex, and was not written by Diabetes Health.

Study Finds Generex Oral-lyn(TM) is Safe, Effective, and May Reduce Complications of Insulin-Dependent Diabetes

Dec 9, 2009

WORCESTER, Mass., Dec 3, 2009 (GlobeNewswire via COMTEX News Network) -- Published in the journal Diabetes, Obesity and Metabolism, an independent review of clinical trials of Generex Oral-lyn(TM) shows that the oral insulin spray has a faster onset of action and shorter duration of action than insulin delivered subcutaneously.

"The ease of use of the insulin spray formulation may increase patient acceptance and treatment compliance, thereby potentially reducing complications and improving quality of life for patients with insulin-dependent diabetes," the review authors wrote.

Generex Oral-lyn(TM) is the flagship product of Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth. Unlike inhaled insulin products, buccally absorbed Generex Oral-lyn(TM) does not have pulmonary side effects. It is safely and efficiently delivered in pain-free, standardized doses via the Company'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.

International Diabetes Federation guidelines identify glycemic control as a crucial factor in management of the disease, yet ensuring insulin therapy compliance can be problematic when up to one-quarter of people with diabetes have needle anxiety (Diabetes Res. Clin. Pract. 1999;46:239-46).

"Patients who are needle averse face a serious barrier to their recommended treatment," warns Generex President and CEO Anna E. Gluskin. "Generex Oral-lyn(TM) promises a pain-free alternative to injectable insulin, which is good news especially for older patients and children who find needles uncomfortable."

The clinical trials of Generex Oral-lyn(TM) include patients with Type 1 and Type 2 diabetes. Incidence of Type 1 diabetes is growing by 3 percent per year in children and adolescents, and at an alarming 5 percent per year among pre-school children. It is estimated that 70,000 children under the age of 15 develop Type 1 diabetes each year -- a rate of almost 200 children each day. Currently, an estimated 440,000 children globally live with Type 1 diabetes. Type 2 diabetes was once seen as a disease of adults, but is also growing at alarming rates in children and adolescents.

"Review of clinical trials: update on oral insulin spray formulation" was authored by Paolo Pozzilli, MD, Director of Endocrinology and Diabetes, University Campus Bio-Medico, Rome; Philip Raskin, MD, Department of Internal Medicine, Southwestern Medical Center, Dallas; and Christopher G. Parkin, MS, Carmel, Indiana. The article was published online this month in advance of print publication in Diabetes, Obesity and Metabolism.

The article is available at http://tr.im/DOM09.

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Categories: Diabetes, Diabetes, Insulin, Medications, Medications Research, Research, Type 1 Issues, Type 2 Issues


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Comments

Posted by Anonymous on 9 December 2009

Generex recently announced that the "U.S. Food and Drug Administration (FDA) has granted approval for the treatment use of Generex Oral-lyn(tm) 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(tm) 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."

The listing to be a part of the Treatment IND is here:

http://clinicaltrials.gov/ct2/show/NCT00948493?term=generex&rank=2

Ilearned that diabetics and physicians can contact Generex at info@generex.com to participate.

Dr Gerald Bernstein, a former President of the American Diabetes Assoc and a VP at Generex, recently talked about this opportunity for US diabetics to take advantage of oral buccal insulin on this health related radio program:

http://www.healthradio.net/show/ask-dr-desilva/Health-Radio-Shows/Ask-Dr-2E-DeSilva/Management-of-Type-I-and-Type-II-Diabetes-41184/details

rjs

Posted by Anonymous on 9 December 2009

Can't wait to see a product like Oral-lyn on the market. I really dislike needles. i heard that Oral-lyn is allready available in some countries? Is it possible to get it here in Belgium?

Posted by Steve Parker, M.D. on 9 December 2009

"Ora-lyn" What a great name!

Posted by whimsy2 on 11 December 2009

I'm a type 1 and my doses are usually pretty small, and often include some fraction of a unit. I base my dose on a complex formula that factors in other variables besides carbs, and using this method I've lived with diabetes for 12+ years with excellent control and no sign of complications. I don't see how one can control the exact amount of insulin when it's taken this way. To my way of thinking there's nothing painful about taking an insulin shot in the belly -- there are very few nerve endings there -- and I think all the bucks spent on research as an alternative to shots could be better spent elsewhere.

Posted by Anonymous on 12 December 2009

Whimsy2, why not share your complex formula at this website? You could make it clear that this formula is what YOU do, that you are not prescribing or recommending it to anyone else. Thanks.

Posted by Anonymous on 22 December 2009

I have been a type 1 diabetic for 36 years. I have an insulin pump and am able to take small dosages if needed. All calculations are controlled by me and programmed into the pump. I never minded the shots or doing the pump site insertions. I thought that inhalled insulin would be good for those that are needle phobic - kids and type 2 diabetics who may be delaying starting insulin because of the shots or extra work involved.
But if Generex Oral-lyn(TM) has a faster onset of action and shorter duration of action than insulin delivered subcutaneously, it could be more effective for correcting high blood sugar and meals that have a lot of fast acting carbs.
What's not mentioned in the article is that type 1 diabetics would still need a long acting insulin to cover their basal (baseline) needs. I also wonder about dosing options - how much would we be able to fine tune it to meet our needs.


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