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Biotech / Medical : Biotech Short Candidates -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (654)	5/5/2004 4:09:28 PM
From: tuck	Read Replies (1) \| Respond to of 897

NKTR looked at both, but not for 12 months. Type 1 six months, Type 2 three months. I belive ARDM's previous studies were six months. So the 12 month study is new territory, and it looks rugged for all explorers, IMO. >>Inhale Reports on Phase III Exubera® Inhaled Insulin Data that Show Comparable Glycemic Control to Insulin Injections and Better Glycemic Control than Oral Therapy San Carlos, CA June 17, 2002 Inhale Therapeutic Systems, Inc. (Nasdaq:INHL) reported today on new data released from Phase III studies conducted by Pfizer Inc. and Aventis Pharma with the Exubera® inhaled insulin product using Inhale's advanced inhaleable technology. The data show that patients with type 2 diabetes, who had failed to meet recommended blood glucose levels with combination oral therapy, achieved better glycemic control with Exubera® inhaled insulin than patients who received only oral agents. In addition, the study results show that Exubera® inhaled insulin provides glycemic control equal to insulin injections in patients with type 1 diabetes. The data were presented at the 62nd annual scientific sessions of the American Diabetes Association, June 14-18, in San Francisco. This brings the total number of patients reported on in Phase III studies to almost 2,000. Study of Patients with Type 2 Diabetes This three-month, Phase III study involved 309 patients who had been diagnosed with type 2 diabetes. There are approximately 17 million people in the United States with diabetes with 90-95% of all cases accounting for type 2 diabetes. Type 2 diabetes is typically associated with older age, obesity, family history and race/ethnicity and is increasingly being diagnosed in children and adolescents. The study examined whether Exubera®, an inhaleable rapid-acting dry powder insulin, could provide better glycemic control when taken alone or in combination with oral agents, compared with patients taking only oral agents. Exubera® was administered before meals. Patients in the study taking either Exubera® alone or Exubera® plus oral agents experienced a significant decrease in the hemoglobin (HbA1c). Patients taking oral agents alone experienced no change in HbA1c levels over the three-month period. The HbA1c levels reflect average blood glucose readings over a period of several months; a level below seven percent is the American Diabetes Association's recommended treatment goal for patients with diabetes. "Currently many patients with type 2 diabetes fail to reach target glucose levels on oral agents, which will eventually lead to the need for insulin therapy," said Dr. Julio Rosenstock, Dallas Diabetes and Endocrine Center and Clinical Professor of Medicine at the University of Texas, Southwestern Medical Center. "This study shows that Exubera® has the potential to help patients with type 2 diabetes by providing an effective and highly acceptable treatment option." Patients taking Exubera® showed also significantly greater decreases in both fasting plasma glucose concentrations (a measurement taken before breakfast) and two-hour post-prandial glucose levels (a measurement taken after a meal) compared to patients who took only oral agents. In addition, target HbA1c levels of less than 8% and less than 7% (recommended ADA action and goal levels, respectively) were achieved by significantly more Exubera® patients. Patients preferred using Exubera® and reported significant improvements in overall treatment satisfaction. Patients also showed more favorable improvements in symptoms and cognitive function, according to a Diabetes Quality of Life and Treatment Satisfaction questionnaire. The majority of adverse events in the study were mild to moderate in all treatment groups. Hypoglycemia rates (abnormally low levels of blood sugar) and weight gain, both common side effects of insulin therapy, were higher in those patients treated with Exubera®. There was an increased incidence of antibody serum binding in patients who used Exubera®, but there did not appear to be any related clinical significance. Pulmonary function remained stable in patients using Exubera® and pulmonary function tests showed no significant differences between groups. Study of Patients with Type 1 Diabetes In this six-month Phase III study, 328 patients with type 1 diabetes received either Exubera®, an inhaleable rapid-acting dry powder insulin taken before meals, plus two daily insulin injections, or a regimen of four insulin injections per day. The patients who received Exubera® experienced a decrease in the glycated hemoglobin (HbA1c) that was similar to patients taking only insulin injections. The HbA1c levels reflect average blood glucose readings over a period of several months; a level below seven percent is the American Diabetes Association's recommended treatment goal for patients with diabetes. In addition, patients who received Exubera® experienced significant reductions in both fasting plasma (blood glucose measurement before breakfast) and two-hour post prandial glucose levels (blood glucose measurement taken after meals) compared to patients who received only insulin injections. "Research has shown that patients with type 1 diabetes who maintain tight blood sugar control will experience major, long-term benefits. However, millions of patients are still not achieving good control," said Dr. Jay Skyler, Professor and Director of the Division of Endocrinology, Diabetes and Metabolism at the University of Miami. "These results show that in patients with type 1 diabetes, Exubera® can offer comparable glucose control to meal-related insulin injections." Patients preferred using Exubera® and reported significant improvements in overall treatment satisfaction. Patients also showed more favorable improvements in symptoms and cognitive function, according to a Diabetes Quality of Life and Treatment Satisfaction questionnaire. The frequency and nature of adverse events reported in the study were comparable in both treatment groups. Mild to moderate cough was seen more frequently in patients taking Exubera®, but decreased in incidence and prevalence over the course of the study. Small relative decreases in one of the pulmonary function tests were seen in the Exubera® treatment group. Pfizer and Aventis are conducting additional studies to further explore whether there is any potential clinical significance to this observation. There was an increased incidence of antibody serum binding in patients who used Exubera®, but there did not appear to be any related clinical significance.<< Edit: Another trial, also three months: nektar.com and the March PR about filing for approval with EMEA: nektar.com So we'll see what EMEA thinks first. I imagine ARDM/Novo's long term data will be on the minds of whatever committee does the reviews over there. Likely to be a binary event for NKTR. ANybody know when we can find out the relevant dates? I've never surfed EMEA before. snip Cheers, Tuck

To: Biomaven who wrote (654)	5/6/2004 4:40:11 PM
From: tuck	Read Replies (1) \| Respond to of 897

I stand somewhat corrected. NKTR/PFE have done extension studies to study the antibody issue. But I don't think they were measuring the post meal glucose profiles at this stage as ARDM/Novo did: pslgroup.com Might be worth trying to get that abstract to see if there is any clarity on that. The docs comments regarding non-relation between antibodies and glucose swings refer to other, shorter trials, I think. A search of the AACE site yielded only an offer to buy an audio tape of the whole meeting for $250. Not the most efficient way to disseminate info. Oh, well. Cheers, Tuck