SOURCE: Generex Biotechnology

March 08, 2006 08:45 ET

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

TORONTO -- (MARKET WIRE) -- March 8, 2006 -- Generex Biotechnology Corporation (NASDAQ: GNBT), 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:

Stabilization Phase        s.c. Regular               Generex
                           Insulin Phase          Oral-lyn Phase
N       Mean     SD       N    Mean     SD       N    Mean     SD
27      172.1    75.2     27   172.1    75.2     29   140.4    35.5
27      139.7    50.1     29   140.4    35.5     29   143.3    39.9
Change  -32.4                  -31.7                    2.9
              < .0005                < .0001                    p =
                                                               0.490
The investigators concluded that during the first two and one-half months 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 DM was associated with overall adequate glycemic control and similar fructosamine and glycosylated hemoglobin (HbA1c) concentrations.

Generex believes that Generex Oral-lyn can make a significant contribution to the achievement and maintenance of metabolic stabilization by providing a safe, simple, fast, effective, flexible, and familiar alternative to pre-prandial insulin injections. As a pain-free and convenient method of insulin delivery, Generex Oral-lyn will allow individual patients to "fine tune" and then maintain their metabolism resulting in an improved quality of life. Accordingly, Generex Oral-lyn provides the opportunity for the establishment of a new and more effective diabetes treatment paradigm.

About Generex

Generex is engaged in the research and development of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist™ device. The Company's flagship product, oral insulin (Oral-lyn™), which has been approved for commercial sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world.

For more information, visit the Generex Web site at www.generex.com.

Safe Harbor Statement: This release and oral statements made from time to time by Generex representatives concerning the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Contact Information

  • Contact:
    Shayne Gilliatt
    Generex Biotechnology Corporation
    Phone: (800) 391-6755 and (416) 364-2551

    Ed Lewis
    CEOcast, Inc.
    Phone: 1 (212) 732-4300