rkrw,
INHL's ADA presentation of PIII results seem to reveal a problem that may be endemic to pulmonary delivery of insulin:
>>PHILADELPHIA--(BW HealthWire)--June 25, 2001--Inhale Therapeutic Systems, Inc. (Nasdaq:INHL - news) reported today on new data released from Phase III studies being conducted by Pfizer Inc. and Aventis Pharma with inhaled insulin (Exubera(TM)) using Inhale's advanced inhaleable technologies.
More patients with type 2 diabetes who were treated with inhaled insulin achieved the recommended blood glucose levels than patients who received only insulin injections, according to data presented by Priscilla Hollander, M.D., Ph.D., Medical Director at Baylor University Medical Center in Dallas and lead investigator for the multicenter Phase III clinical trial. The data were presented last evening at the American Diabetes Association's 61st Scientific Sessions in Philadelphia.
The six-month study involved 299 patients with type 2 diabetes who were divided into two groups. One group received inhaled insulin (Exubera(TM)) prior to meals plus a single bedtime dose of Ultralente (long-acting insulin); the other received a conventional regimen of insulin injections. The data showed that HbA1c levels decreased similarly in both groups and that inhaled insulin provided comparable glycemic control to that in the conventional subcutaneous insulin regimen. In addition, inhaled insulin achieved target HbA1c levels of less than 7.0% in a greater proportion of patients compared to injected insulin (46.9% of patients receiving inhaled insulin over 31.7% of patients receiving subcutaneous injections).
The HbA1c level reflects blood glucose readings over a period of several months; a level below 7.0% is the American Diabetes Association's recommended treatment target for patients with diabetes. Unless properly controlled, diabetes can result in serious medical complications that include kidney failure, blindness, impotence and cardiovascular and neurological disorders.
The frequency and nature of adverse events were comparable between groups. Pulmonary function tests showed no significant differences between patients receiving inhaled insulin versus those who received injections only. The most common respiratory clinical side effect reported among patients was cough, which was characterized as mild to moderate in nature. Patients who used inhaled insulin developed increased insulin antibody serum binding, but there did not appear to be any related clinical significance.
Conclusions reached by the study group suggested that treatment with inhaled insulin is effective and well tolerated in patients with type 2 diabetes. Further, the availability of inhaled insulin may lead to earlier introduction of insulin therapy and improved glycemic control in patients with type 2 diabetes.<<
snip & emphasis mine
Does this mean that the inhaled insulin, found by the body in a strange place, gets attacked by antibodies? That's what it seems to be saying. Yet not clinically significant? Maybe, but The Street apparently doesn't expect the FDA to casually wave that off; INHL is down hard. Wondering if we'll see anything like this from ARDM. Better listen to their conference call this evening, I guess:
>>PHILADELPHIA, Jun 25, 2001 /PRNewswire via COMTEX/ -- Aradigm Corporation (Nasdaq: ARDM chart, msgs) today announced that the company will host a conference call and Webcast of its analyst meeting at the American Diabetes Association (ADA) Meeting on Monday, June 25, 2001. Executives from Aradigm and Novo Nordisk and guest speaker Robert Ratner, M.D. of MedStar Research Institute and George Washington University School of Medicine will speak on the future of diabetes management and the recent progress and advantages of the AERx(R) Diabetes Management System.
Date: Monday, June 25, 2001
Time: 7:45 pm Eastern, 4:30 pm Pacific
Internet: www.aradigm.com
Telephone: (800) 231-9012
International callers, dial (719) 457-2617
Access code: 438203
A replay of the conference call will be available for one week following the call, which can be accessed on www.aradigm.com or by dialing (888) 203- 1112. International callers should dial (719) 457-0820. The replay access code is 438203.<<
snip
Cheers, Tuck |
