Generex Biotechnology Corp. plans to start a pivotal Phase III trial of Oral-lyn, its oral insulin spray product, in patients with Type I diabetes mellitus next quarter, the company said at the American Diabetes Association meeting in Chicago.

The Worcester, Mass.-based firm expects to begin patient dosing before the end of the year at multiple centers across the U.S., Canada and Europe. The primary objective of the six-month, 750-patient study is to evaluate the efficacy of Oral-lyn, administered using the RapidMist Diabetes Management System, compared to the standard injectable human insulin therapy, as measured by hemoglobin A1C (HbA1C). The protocol was approved by Health Canada, and the FDA review period for the protocol recently lapsed without objection.

Generex's flagship product, Oral-lyn is a liquid formulation of regular human insulin that's delivered to the buccal mucosa by the RapidMist device so that absorption is limited to the mouth and the drug does not enter the patient's lungs. It already is on the market for Type I and Type II diabetes patients in Ecuador, and is at various stages of development around the world. Previous studies have shown the product to have faster onset than existing injectable insulin products and that it can be used safety on a long-term basis without any adverse effects.

Shares of Generex (NASDAQ:GNBT) fell 5 cents Tuesday to close at $1.84.

In other ADA news:

• Amylin Pharmaceuticals Inc., of San Diego, reported three-year, open-label study results showing that treatment with Byetta (exenatide) injection was associated with sustained blood sugar control and progressive weight loss in people with Type II diabetes. The trial involved 217 patients who were not achieving adequate blood sugar control on oral medication alone (metformin and/or sulfonylurea). After three years of treatment with Byetta in addition to the oral medications, 46 percent of participants achieved the ADA's recommended target A1C of 7 percent, and 30 percent achieved an A1C of 6.5 percent. Weight loss from baseline was progressive, with patients losing on average 11.68 (+/- 0.88) pounds at three years. One in four patients lost an average of 28.66 pounds. Byetta is approved as an adjunctive therapy for Type II diabetes patients who are not achieving blood sugar control using metformin, a sulfonylurea or a thiazolidinedione.

• SemBioSys Genetics Inc., of Calgary, Alberta, reported preclinical data supporting the development of plant-derived recombinant human insulin, with results demonstrating that the company exceeded its commercial target levels of insulin accumulation in safflower. Laboratory results also showed that safflower-produced insulin is physically, structurally and physiologically indistinguishable from pharmaceutical-grade human recombinant insulin, and results from animal studies demonstrated the pharmacodynamic equivalence of safflower-derived insulin to pharmaceutical-grade insulin. SemBioSys expects to enter Phase II testing in early 2008 and, pending successful results, anticipates commercialization of safflower-produced insulin as early as 2010.

• Tranzyme Pharma, of Research Triangle Park, N.C., reported positive results from a pilot Phase IIa study of TZP-101, an intravenous ghrelin agonist, in accelerating gastric emptying in diabetic patients with gastroparesis. Using scintigraphy and a standardized meal, the study assessed the efficacy of three dose levels of TZP-101, all of which significantly accelerated gastric emptying, while placebo had no effect. Tranzyme previously reported that the drug demonstrated tolerability, safety and a good pharmacokinetic profile in two Phase I studies, and it plans to initiate Phase II development of TZP-101 in both postoperative ileus and severe gastroparesis in the third quarter. The company also is developing TZP-102, an oral ghrelin agonist that is expected to start Phase I testing early next year in mild to moderate chronic gastroparesis.

• University of Florida College of Medicine in Gainesville reported data from a small pilot study showing that transfusion of stored, autologous umbilical cord blood into a group of children newly diagnosed with Type I diabetes appeared to reduce disease severity, possibly resetting the immune system and slowing the destruction of insulin-producing cells. Researchers recruited seven children, ages 2 to 7, with Type I diabetes who had stored cord blood. At the end of the study, those children had lower average A1Cs compared to a control group of 13 children who were treated with insulin (7 percent A1C vs. 8.04 percent). Researchers now hope to identify the cord blood cells that yielded the benefit, isolate those cells and grow them into therapies to treat a larger patient population.