Clinician Presents Generex Oral-lyn(TM) Clinical Data at the Pediatric Academic Societies' 2006 Annual Meeting
05-02-06 08:00 AM EST --(MARKET WIRE)--
TORONTO -- (MARKET WIRE) -- 05/02/06 -- Generex Biotechnology Corporation (NASDAQ: GNBT), a leader in the area of buccal drug delivery, announced today that Dr. Jaime Guevara-Aguirre, M.D., of the Institute of Endocrinology IEMYR in Quito, Ecuador, was invited to make a late-breaker platform presentation of Generex Oral-lyn(TM) clinical data on May 1, 2006 at the Pediatric Academic Societies' 2006 Annual Meeting in San Francisco.
Dr. Guevara's presentation was entitled "Preliminary Results from a 6-Month Study on the Safety and Efficacy of an Oral Insulin (Generex Oral-lyn(TM)) Administered at Lunch Time in Adolescent and Young Adult Type-1 Diabetes Mellitus Subjects Maintained on Basal Subcutaneous Glargine Insulin and Pre-Breakfast and Pre-Dinner Subcutaneous Regular Insulin."
"We are most gratified that the scientific community has recognized the importance of this study and the significance of these preliminary results and invited the principal investigator to make a podium presentation of the clinical data at this important scientific symposium," said Anna Gluskin, President & Chief Executive Officer of Generex.
Participating subjects in this 6-month study are 24 adolescents (12M; 12F) and five young adults (2M; 3F) referred to the Institute of Endocrinology IEMYR in various degrees of metabolic control as reflected by altered baseline measurements of glucose 236.6 (116.6) mg/dL; fructosamine 472.6 (126.6) umol/L; and glycosylated hemoglobin (HbA1c) 9.8 (2.3) g/dL. Baseline demographics of the 24 adolescents are: Age 14.7y (2.1); Bone age 14.1 (2.2); CA/BA 1.0 (0.1); Height 153.8cm (9.4); Weight 51.0kg (10.2); BMI 21.7 (3.2); Duration of DM 6.7 (2.8). Baseline demographics of the 5 young adults are: Age 20.6y (2.2); Bone age (BA) 18.8 (0.4); CA/BA 1.1 (0.1); Height 161.1cm (12.8); Weight 62.5kg (9.3); BMI 23.0 (1.8); Duration of DM 7.0 (1.7). Mean age for the entire group is 15.7y (3.0); BA 14.9 (2.7); CA/BA 1.1 (0.1); Duration of the DM is 6.8 (2.6).
After stabilization with basal subcutaneous glargine insulin and three pre-prandial subcutaneous regular insulin injections, standard therapy continued for four weeks for comparison. Immediately thereafter, split doses of Generex Oral-lyn immediately before and after lunch replaced lunch time injections of regular insulin. Patient-collected glucose values, fructosamine, and HbA1c were compared weekly (3-4 weeks per each treatment). Values are reported at the end of each phase.
FRUCTOSAMINE HbA1C GLUCOSE (BASAL)
PHASE MEAN SD MEAN SD MEAN SD
BASELINE 476.89 130.22 9.9 2.38 236.6* 116.5
REGULAR
INSULIN 368.2 91 8.4 1.6 140.4 35.5
ORAL-LYN 379.1 133 8.5 2.1 143.3 39.9
COMPARED
TO BASELINE < .0001 < .0001 < .0005
10-WEEK DATA 377.9 98 7.9 1.6
(*Glucose values at baseline were determined by laboratory; other glucose values were determined by glucometer)
After comparison, a 6-month study of Generex Oral-lyn treatment at lunchtime was initiated. Fructosamine and HbA1c results between the 8th and 10th week of treatment demonstrated that fructosamine and HbA1c levels maintain the trend towards normalization.
In summary, successful replacement of regular subcutaneous insulin with Generex Oral-lyn during the initial 10 weeks of this 6-month trial was achieved as demonstrated by patient-collected glucose levels, fructosamine, and HbA1c measurements.
In addition to the podium presentation, Dr. Guevara made a poster presentation at the symposium of a study entitled "A 12-Day Comparison of Preprandial Humulin-R? vs. Generex Oral-lyn(TM) in 10 Type-1 Diabetic Subjects Receiving Baseline Glargine Insulin Therapy."
The aim of this pilot study was to determine the suitability of dose and formulation of Generex Oral-lyn for its use in a larger multi-center trial. The study also compared the glucodynamics of both rapid insulins (Generex Oral-lyn and Humulin-R?) in 10 Type-1 diabetic subjects receiving glargine insulin as their baseline therapy. Fructosamine, a parameter of protein glycation, was determined as part of a panel of safety monitoring.
10 Type-1 Diabetes Mellitus (DM) research subjects received their usual baseline glargine insulin (Lantus?) therapy twice daily (BID: 2/3rd in the morning and 1/3rd in the evening). Depending on present glycemia, Humulin-R was dosed as a pre-meal subcutaneous injection during days -3, -2 and -1. Five to eight puffs of Generex Oral-lyn were given pre- and post-prandially on days +1 through +9. Adjustments of glycemia were done using standard snacks, additional subcutaneous Humulin-R or Generex Oral-lyn puffs.
Peripheral glucose measurements were self-monitored by the 10 DM Type-1 research subjects in duplicate at each time-point by using a common standard method (Accu-Chek?). The peripheral glucose concentration average of the 2-value performed at each time-point for the 9-day Generex Oral-Lyn (O), and 3-day Humulin-R (H) are hereby provided: Pre-Breakfast (B): 70.26 (O) vs. 91.08 (H); 1-hour (h) post-B: 138.50 (O) vs. 151.45 (H) ; 2-h post-B: 113.92 (O) vs. 108.18 (H); Pre-Lunch (L): 84.82 (O) vs. 98.55 (H); 1-post-L: 142.00 (O) vs. 140.77 (H); 2-h post-L: 113.55 (O) vs. 106.28 (H); Pre-Dinner (D): 92.84 (O) vs. 100.78 (H); 1-post-D: 141.31 (O) vs. 139.43 (H); 2-h post-D: 119.62 (O) vs. 109.94 (H). The corresponding Area Under the Curve for both treatments were compared and no statistical significance was found (p = 0.6875).
Using BID glargine insulin (Lantus) as baseline therapy, Humulin-R and Generex Oral-lyn induced similar glucodynamic responses during the 12-day observation period. Intensive monitoring and timely corrections with additional snacks, Humulin-R or Generex Oral-lyn resulted in an appropriate glycemic control as assessed by individual daily-glycemic curves and, especially, normal preprandial glycemia. Measurements of protein glycosylation displayed a tendency to lower values after the 12-day study period.
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(TM) device. The Company's flagship product, oral insulin (Oral-lyn(TM)), 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.
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