Impressive news dominated the headlines at the 56th American Society of Hematology annual meeting regarding anti-cancer powerhouse Pomalidomide. Results from a comprehensive study conducted by Celgene Corporation, the company that markets the brand name of Pomalidomide, POMALYST, were extremely encouraging. The trial, coined STRATUS, involved 599 patients suffering from refractory or relapsed multiple myeloma. Patients enrolled in the trial received a combination dose of Pomalidomide and low-dose Dexamethasone, with results showing primary and key secondary endpoints were met. The primary endpoint of safety was overwhelmingly clear, which was particularly reassuring for this patient population with refractory multiple myeloma.
While the main goal of this study was safety, secondary goals included exposure rate to Pomalidomide, overall response rate, overall survival. progression free survival and cytogenetic analyses. Of the patients enrolled all had received at least five previous therapies, as well as thromboprophylaxis therapy of low dose aspirin or low molecular weight heparin. Approximately four medication cycles were dispensed to study participants and a follow up was assessed at 6.8 months. The median overall response rate was 4.2 months and the average progression free survival rate was 11.9 months. A healthy 35 percent of patients who received the Pomalidomide and Dexamethasone combination experienced a positive overall response rate, with 8 percent of these patients achieving a very good partial response rate. Grade three and four adverse events were uncommon, with the most common effects noted being neutropenia. Dosing of Pomalidomide for patients in the STRATUS study began at 4 milligrams daily for days 1-21 of a 28 days cycle. Patients were also administered 40 milligrams daily of Dexamethasone on days 1,8,15 and 22. Patients over the age of 75 were given a reduced amount of Dexamethasone, specifically 20 milligrams, on days 1,8,15 and 22.
Pomalidomide is FDA approved for patients with multiple myeloma who have received at least two prior therapies and have shown disease progression within 60 days of their last therapy. As an effectual immunomodulatory agent, Pomalidomide is an easy to dispense oral treatment that has proven to have activity in highly resistant disease. The American Cancer Society estimates that as of 2015 roughly 26,850 new cases of multiple myeloma will be diagnosed in American adults, with a little more than half of these cases being men. Approximately 11,240 deaths are expected to occur as a result of this virulent disease. LGM Pharma can assist clients as a supplier/distributor of the API Pomalidomide, CAS #19171-19-8, as well as Dexamethasone, CAS # 50-02-2 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.
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