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AeroGen Inc. has initiated Phase II clinical trials using its AeroDose insulin inhaler in diabetics. The studies are designed to characterize the delivery and efficacy of inhaled insulin in Type 2 diabetics.
Alliance Pharmaceutical Corp. says enrollment is complete for its pivotal Phase II/III trial for perflubron (LiquiVent), an intrapulmonary agent for the treatment of acute lung injury and acute respiratory distress syndrome. Perflubron is an oxygen-carrying liquid agent under development with fast-track designation from the FDA. The liquid is administered to the lungs of patients supported by a mechanical ventilator and is anticipated to decrease the number of days that mechanical ventilation is required by patients.
Amylin Pharmaceuticals Inc. has submitted a New Drug Application to the FDA for its lead diabetes agent, pramlintide acetate (Symlin). Amylin wants to market pramlintide as an adjunctive therapy to insulin for the treatment of patients with Type 1 or Type 2 diabetes who use insulin. Pramlintide is a synthetic form of human amylin, a hormone secreted with insulin by the pancreas. In clinical trials, pramlintide demonstrated the ability to improve blood glucose control significantly without weight gain and without increase in severe hypoglycemic event rates.
AstraZeneca announces Crestor as the trade name for its investigational HMG CoA reductase inhibitor, rosuvastatin calcium. Rosuvastatin was formerly referred to as ZD4522. More than 4,000 patients have been enrolled in Phase III clinical trials for the drug. It is expected that data from some of these trials will be presented at the American College of Cardiology meeting in March 2001.
Cellegy Pharmaceuticals Inc. announces initiation of an expanded Phase I/II trial for its product, Tostrelle, a transdermal testosterone gel designed for the treatment of female sexual dysfunction. Low levels of testosterone in females can lead to muscle and bone mass, and decreased energy level, in addition to decreased libido.
Cell Genesys Inc. reports positive results of its GVAX prostate cancer vaccine. Phase II data have demonstrated anti-tumor activity in patients with advanced metastatic prostate cancer who have failed hormone therapy. Thirty-four of 55 patients in the trial had metastatic prostate cancer in the bone with positive bone scans at start of therapy. These 34 were assigned to either low-dose (n=24) or high-dose (n=10) treatment with GVAX as monotherapy. Post treatment follow-up of these 34 patients showed a trend toward prolonged progression free survival (measured by bone scan). The median time to progression was 140 days for the high-dose group and 85 days for the low-dose group. The remaining 21 patients who did not have positive bone scans at start of study was 179 days.
Epimmune Inc. reports results of tests showing that its vaccine designed to treat breast, colon, and lung cancers stimulates strong immune responses in animal models and in human cells used in lab tests. Vaccines such as this that are able to boost the immune system’s ability to recognize and destroy tumor cells may meet a currently unmet need in cancer armamentarium.