Diabetes Treatment News

/ April 1st, 2011/ Posted in Diabetes / No Comments »

Bariatric Surgery coming into its own

Earlier this week the International Diabetes Federation (IDF) released a position statement regarding bariatric surgery as an option for Type 2 Diabetes and obesity. According to their distinguished panel of experts, bariatric surgery should now be considered an appropriate treatment option for people with Type 2 diabetes and obesity if treatment goals are not being met by the traditional medical therapies. But, having said that, if you have diabetes and are overweight, don’t rush out to book your surgery just yet. Do your homework on the subject, research your options and seek the advice of your endocrinologist prior to scheduling surgery. There are guidelines and criteria that should be met to be an eligible candidate for bariatric surgery.

Bariatric surgery is not one specific type of surgery, but rather a group of surgeries, all of which are used to treat obesity. Bariatrics is defined as the field of medicine that study’s and treats obesity. Three of the most common types of bariatric surgeries include: Gastric Bypass surgery, Adjustable Gastric Band surgery and Gastric Sleeve surgery (also referred to as Sleeve Gastrectomy).

Gastric Bypass surgery is the oldest of the group and therefore, is the type of bariatric surgery most people are aware of. It involves sectioning off a part of the stomach and rerouting the intestine to that segment of the stomach. Reduction in the stomach’s capacity results in a rapid weight-loss. However, one of the main drawbacks is that the procedure is permanent (non-reversible). Another major complication is nutritional deficiencies that are often associated with this type of surgery.

Adjustable Gastric Band surgery is another type of bariatric surgery that is performed macroscopically. It sections off a small pouch of the upper stomach using an inflatable band that can be adjusted to maximize the person’s weight-loss. The initial weight-loss is slower than with bypass surgery, but is also considered a less invasive procedure. A major benefit is that this type of surgery is reversible. Initial studies found gastric band surgery to be considered very successful. But complaints of weight regain and band complications have led to many people reversing the procedure and or being dissatisfied with the outcome. Band erosion and band slippage are common complications found in several long-term studies.

The final of the three is Gastric Sleeve Surgery. It is a relatively new procedure and is receiving a lot of attention, especially from dissatisfied gastric band patients. The procedure involves either removing part of the stomach (gastrectomy) or folding and suturing of part of the stomach (plication). The result is a smaller sleeve like stomach that holds less food and allows the patient to feel full with decreased caloric intake, which results in weight-loss. The plication technique has the advantage of being reversible, whereas, the gastrectomy approach is of course permanent.

All three of the procedures have received mixed reviews, but obviously the IDF experts feel it is a viable intervention for morbidly obese patients with type 2 diabetes. But, the patient must remember there is no magic bullet (or surgery) regarding weight-loss. Along with the surgery, a commitment to change one’s eating habits; exercise patterns and general lifestyle are crucial to long-term weight-loss success.

These surgical procedures are tools that may help a person lose weight and manage their diabetic condition, but it is imperative that the patient work closely with his or her medical team prior to surgery and during the post-surgical process. If you feel you fit the criteria (outlined by the IDF), make an appointment to see your endocrinologist regarding bariatric surgical options. The experts have stated their position: bariatric surgery is now a viable option in the treatment of type 2 diabetes and obesity, under certain circumstances!

Could the Treatment For Depression Be the Same As the Treatment For Diabetes?

For decades, physicians, mental health experts and individuals have struggled to find answers to the crippling problems of depression. Now, researchers have posed an interesting new theory: insulin.

Researchers at the University of Toronto stated Monday that intriguing new research seems to suggest that insulin has much more impact on the brain and mood disorders than previously thought.

A trial completed in early March at Mount Sinai Hospital in Toronto saw patients with depression being treated with nasal insulin rather than traditional methods. While it’s in the very early days, the results appear to be positive.

The issue with treating mental health is that even the most recent advances in pharmaceutical treatments are no more effective at treating or controlling depression than the drugs on the market in the 1950s. This new research seems to suggest that perhaps a wholesale alteration to treatment approaches are necessary. Part of the urge to point research in this direction was the fact that 50% to 75% of depression and bi-polar patients are either diabetic, obese or overweight. Other research has shown that insulin plays a significant role in the development of the brain and other neurological functions, said Dr. Roger McIntyre, a psychiatrist and University of Toronto researcher.

“If you step out of psychiatry and you look into another area, like diabetes, a condition defined by insulin problems, those individuals on the surface have many of the same problems that our patients have,” he said in the National Post. “They have lots of mood disturbances and cognitive changes and their brains are as affected as our patients.”

Given that this research is in its infancy, it will be years before enough trials can be run to determine a scientifically proven link, and even longer before effective treatments can be based on the research. Still, it’s a hopeful line of attack and one that could bode well for treatments in the future.

Omni Bio Pharmaceutical, Inc’s. CEO Issues Letter to Shareholders

DENVER, March 31, 2011 /PRNewswire/ — Omni Bio Pharmaceutical, Inc. (OTC BB: OMBP), today issued the following letter to shareholders of the Company:

To the Shareholders of Omni Bio Pharmaceutical, Inc.:

I am writing to you having completed my first month as the Chief Executive Officer of Omni Bio Pharmaceutical, Inc., (“Omni”). With our 2011 Fiscal year coming to a close, this is an appropriate juncture to update our shareholders on the basis for my optimism in your Company’s prospects, and to advise you of my initiatives to increase shareholder value. I intend to keep you updated periodically going forward, the timing of which will be dictated by substantive scientific or business developments.

As you may be aware, I served on the Scientific Advisory Board (“SAB”) of Omni for approximately two years prior to accepting the role as CEO of the Company, and I would like to provide you with my observations about the magnitude of this business opportunity and our progress. During my involvement with Omni’s SAB, I became aware of scientific research in animal models related to the potential uses of Alpha 1 antitrypsin (“AAT”) in numerous disease classifications. I believe the results of these animal models are compelling in terms of their potential significance if similar results can be obtained in a human population.

These studies, which were largely conducted by investigators not associated with Omni, but where Omni controls intellectual property, made it clear to me that the opportunity for Omni to advance its intellectual property into a number of additional disease classifications was significant and persuasive. When I was approached by your Board of Directors to assume the Chief Executive Officer role, I believed that Omni’s science had the potential to have a significant impact on human disease.

At this point in my career, I am interested in developing life changing therapies and I believe Omni’s opportunity provides that situation for me.

Omni is involved with the development of intellectual property related to methods of use patent applications and issued patents related to AAT, a human biological that is FDA-approved for the treatment of chronic obstructive pulmonary disease (“COPD”) and emphysema in AAT deficient patients. Because of the approximately 20 year history of AAT being used to treat COPD and Emphysema, AAT has a solid established safety record, and this assisted us in obtaining FDA clearance to begin our trial in Type 1 diabetes within 12 months of its submission to the FDA. We believe that our method of use patent applications will control the treatment of Type 1 diabetes utilizing AAT, should we obtain the requisite FDA approval.

Our most advanced program is our Phase I/II human clinical trial in Type 1 diabetes involving AAT in recently diagnosed patients at the Barbara Davis Center for Childhood Diabetes in Denver at the Anschutz Medical Campus of the University of Colorado Denver. For this trial, we are using a branded formulation of AAT which is being provided by an existing manufacturer. We initiated this clinical trial this past October, and are approaching completion of the young adult population’s infusion stage, before we move into pediatric patients.

Type 1 diabetes is a large market, there are over two million individuals with Type 1 diabetes in the United States, and we believe that 25-30,000 that have been recently diagnosed have residual islet function. There is no effective form of therapy currently available to the market to block this debilitating and life shortening disease. Based on the addressable market size and anticipated cost of the drug, this would approximate a potential US market of $700 million annually, which is larger than the existing market for AAT for the treatment of COPD and emphysema. Our plan is to sublicense our intellectual property rights for diabetes and our other intellectual property disease classifications to one or more of the existing manufacturers of AAT, hence avoiding the capital intensive investment in plant, equipment and associated sales force.

Although there is optimism about our study’s prospects within Omni, we are not alone in our optimism. The Immune Tolerance Network (“ITN”) has initiated a similar trial of AAT utilizing Aralast NP in Type 1 diabetics (http://www.retainstudy.org/). The ITN is a non-profit, government-funded consortium of researchers working together to establish new treatments for diseases of the immune system. The ITN was founded in 1999 by the National Institute of Allergy and Infectious Diseases (a part of the National Institutes of Health ) and receives support from the National Institute of Diabetes and Digestive and Kidney Diseases and the Juvenile Diabetes Research Foundation (“JDRF”). The ITN study follows on the heels of two failed Type 1 diabetes studies that had been funded by ITN utilizing other drugs. I consider the Immune Tolerance Network’s decision to invest their resources in this trial as an important endorsement of our concept that AAT is a promising therapy for Type I Diabetes.

In addition to the recently commenced ITN study, Israel’s Kamada, LTD recently filed for an IND utilizing their formulation of AAT on Type 1 diabetes. Kamada received FDA approval for its formulation of AAT this past summer and has become aware of our clinical trial in Type 1 diabetes over the past 15 months. We believe their filing an IND with the FDA is a clear indication that they believe the potential for AAT to treat Type 1 diabetes is significant.

Over the course of the past 12 months Omni has been invited to attend and/or present at a number of conferences which have included the Jefferies 2010 Global Healthcare Conference (New York), the 2011 JP Morgan Healthcare Conference (San Francisco), and the Biotech Showcase-2011 (San Francisco). These conferences have provided us with opportunities to meet with research analysts, investment bankers and potential industry collaborators for Omni. We intend to continue to pursue the regular attendance of investment conference opportunities in our next fiscal year.

In addition, I believe our intellectual property pipeline gives Omni other opportunities for commercialization. During the course of this year, we may initiate additional clinical trials, which are contingent upon the receipt of additional financing. Each of these trials addresses significant disease classifications with potentially larger markets than Type 1 diabetes. Indications such as transplant rejection and the prevention of graft vs host disease are likely to be areas that will gather the most impetus from Omni due to the ability to generate clinically relevant data in short periods of time.

I am enthusiastic about our prospects and look forward to reporting to you periodically on our progress.


James D. Crapo, MD

Chief Executive Officer

Omni Bio Pharmaceutical, Inc.

About Omni Bio Pharmaceutical, Inc.

Omni Bio Pharmaceutical, Inc. (www.omnibiopharma.com) is an emerging biopharmaceutical company formed to acquire, license, and develop existing therapies for indications with substantial commercialization potential. Omni Bio’s core technology and pipeline are based on issued and pending patents licensed from the University of Colorado Denver (“UCD”) and a privately held corporation surrounding the broader therapeutic potential of currently marketed therapies. One of Omni Bio’s lead development programs is evaluating an FDA-approved, off-patent drug, AAT, for the treatment of Type 1 diabetes. Novel discoveries made at UCD indicate that AAT has the potential to address a variety of indications in the areas of bacterial and viral disorders, biohazards, diabetes and transplant rejection. For additional information, please visit www.omnibiopharma.com.

Forward-Looking Statements

Some of the statements made in this press release are forward-looking statements that reflect management’s current views and expectations with respect to future events, including the expansion and commencement of clinical trials and the outcome and expenses of such trials. These forward-looking statements are not a guarantee of future events and are subject to a number of risks and uncertainties, many of which are outside our control, which could cause actual events to differ materially from those expressed or implied by the statements. These risks and uncertainties are based on a number of factors, including but not limited to receipt of adequate funding to expand and commence clinical trials; receipt of applicable regulatory approvals for clinical trials, the risks related to the ownership and enforceability of our licensed intellectual property necessary to conduct the clinical trials and the business risks disclosed in our SEC filings, especially the section entitled “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended March 31, 2010. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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