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Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly) -- Ignore unavailable to you. Want to Upgrade?

To: TokyoMex who wrote (756)	9/9/1998 8:03:00 AM
From: Anthony Wong	Read Replies (1) \| Respond to of 1722

[PFE] Inhale Announces Preliminary Phase IIb Results of Trial Combining Inhaled Insulin with Oral Agents Wednesday September 9, 7:31 am Eastern Time Company Press Release Type 2 Diabetics Can Achieve Markedly Improved Glycemic Control with a No-Injection Regimen Combining Inhale's Pulmonary Insulin for Patients Poorly Controlled on Oral Agents SAN CARLOS, Calif.--(BW HealthWire)--Sept. 9, 1998-- Inhale Therapeutic Systems, Inc. (NASDAQ:INHL - news) today announced preliminary results from a Phase IIb trial showing that individuals with type 2 diabetes can markedly improve their glycemic control without insulin injections by combining Inhale's pulmonary insulin with oral diabetes agents. The new results were collected from 56 of 69 outpatients in an on-going three-month Phase II multi-center clinical trial conducted by Inhale's collaborator, Pfizer Inc. (NYSE:PFE - news). Patients who were failing to control their diabetes with oral agents alone achieved control using pulmonary insulin in combination with oral therapy without the need for insulin injections. The complete results from the 56 patients showed that Hemoglobin A1c levels -- used to measure levels of glycemic control -- were lowered by an average of 2.3% percentage points from 9.8% to 7.5% in the group using pulmonary delivery, while patients using oral agents alone showed little change (9.9% to 9.8%). Of the patients using pulmonary delivery in combination with oral agents, 97% opted to continue on pulmonary insulin following the completion of the trials. This new data is being presented at the European Association for the Study of Diabetes (EASD), Sept. 8-11, in Barcelona by clinical investigators collaborating with Pfizer. Inhale had previously announced Phase IIb results demonstrating that pulmonary insulin provided comparable mealtime control as injected insulin for both type 1 and type 2 diabetics. Need for Improved Insulin Delivery Inhale believes that pulmonary delivery could increase the use of insulin and expand the $3 billion worldwide market for insulin and its delivery systems. Insulin is currently used to treat an estimated 3.5 million type 1 and type 2 diabetics. There are approximately 10 million diagnosed diabetics in the United States, of which 90% are type 2 (adult onset). Over 50% of the diagnosed type 2 diabetics are on oral agents and a significant number of these patients are unable to control their diabetes with oral agents alone. ''This data shows that type 2 diabetics poorly controlled on oral agents could benefit from inhaled insulin therapy. We believe that by eliminating the need for injections for many diabetics, our pulmonary system has the potential to broaden the usage of insulin,'' said Robert Chess, Inhale CEO and President. Use of insulin can play an important role in the management of diabetes. However, many diabetics choose not to use insulin due to their dislike of injections. Poorly treated or left untreated, diabetes can lead to a variety of life-threatening complications, such as blindness, kidney disease, heart disease and stroke. It is one of the most costly health problems in the United States. Total direct and indirect costs, including those related to diabetes treatments as well as lost productivity, were approximately $98 billion in 1997. Summary of Preliminary Trial Results The objective of this on-going trial was to examine whether the short-acting inhaled insulin delivery system could offer therapeutic benefit in a no-injection regimen for type 2 patients poorly controlled by oral agents alone. In this trial, 69 patients from 10 sites were randomized to a three-month treatment period using either their usual oral agent alone or their oral agent plus one to two puffs of inhaled insulin before meals. The oral agents used were sulfonylurea and/or metformin. Both groups started at unacceptable glucose levels. Of the 56 patients with complete data, the group adding inhaled insulin started at 9.8% while the group on oral agents alone started at 9.9%. Those on the oral agent alone had little change in the HbA1c level after 12 weeks and ended the 12th week at 9.8%. Those receiving pulmonary add-on therapy showed a significant improvement by reducing the HbA1c level by 2.3% to a level of 7.5%. In the group using the add-on inhaled insulin, there was only one episode of severe hypoglycemia for the entire study population requiring the assistance of another person; and an average of approximately 0.5 mild to moderate episodes per month per patient, which is consistent with improved glycemic control. The inhaled insulin was well tolerated and no changes in lung function were noted as measured by standard pulmonary tests (FEV, FVC and DLco.) Pulmonary insulin was well-liked among these patients, and 32 of the 33 patients (97%) opted to continue on pulmonary insulin following the completion of the trial. Additional results of the Phase IIb pulmonary insulin trial, in 121 type 1 and type 2 diabetic patients currently using insulin therapy, were presented by Pfizer in June 1998 at the annual meeting of the American Diabetes Association. The June results demonstrated that pulmonary delivery of mealtime insulin during the three-month clinical trial period produced blood glucose control and dose-to-dose reproducibility comparable to that achieved with insulin injections. To date, diabetics have been using Inhale's pulmonary delivery system for as long as 20 months. Inhale, located in San Carlos, Calif., is developing pulmonary delivery systems to enable a range of drugs, including peptides and proteins, to be delivered by the pulmonary route for systemic and local lung indications. The company has six drugs in human clinical trials using its delivery system and has feasibility and development partnerships with several pharmaceutical, biotechnology, and medical technology companies, including Pfizer, Lilly, Baxter and Centeon. This release contains forward-looking statements that reflect management's current views as to the company's collaborative arrangements, clinical trials, product developments, manufacturing scale-up, and other future events and operations. These forward-looking statements involve uncertainties and other risks that are detailed in Inhale's reports and other filings with the SEC, including its Form 10-K for the year ending Dec. 31, 1997. Actual results could differ materially from these forward-looking statements.