Key Developments For EpiCept Corporation
EpiCept Corporation (EPCT.O) (Consolidated Issue listed on NASDAQ Capital Market)
EpiCept Corporation Announces Health Canada Accepts Ceplene Application For Review
EpiCept Corporation announced that Health Canada has accepted for review the Company's New Drug Submission (NDS) for Ceplene (histamine dihydrochloride) for the remission maintenance of acute myeloid leukemia (AML) patients in first complete remission. Health Canada`s performance target for the completion of review and a decision is within 300 days. EpiCept also announced that Israel`s Ministry of Health has accepted a marketing application for Ceplene for the remission maintenance of AML patients in first remission. The Company's distribution and marketing partner for Ceplene in Israel, Megapharm Ltd., filed the application and will market Ceplene upon approval. A decision on this application is anticipated late next year.
EpiCept Corporation Announces Filing of New Drug Submission for Approval of Ceplene in Canada
EpiCept Corporation announced that it has filed a New Drug Submission (NDS) with Health Canada for Ceplene (histamine dihydrochloride) for the treatment of acute myeloid leukemia (AML) patients in first complete remission. Health Canada typically accepts or refuses an NDS and designates review status within forty-five days of filing. If accepted, the customary timeframe for completion of review and an approval decision is within one year.
EpiCept Corporation Initiates Post Approval Clinical Study With Ceplene
EpiCept Corporation announced that it has started a post-approval clinical study with Ceplene (histamine dihydrochloride) following Ethics Committee and Competent Authority approvals in Sweden, Belgium, and France. This study will fulfill the post approval commitments requested by the European Medicines Evaluation Agency (EMEA) in granting marketing authorization. Ceplene is indicated for remission maintenance in adult patients with Acute Myeloid Leukemia (AML) in first remission. Cepleneis to be administered in conjunction with low-dose interleukin-2 (IL-2). This study will enroll up to 150 patients at approximately 25 centers across Europe with sites in Sweden, Belgium, France, the U.K., Spain and Italy. The two primary objectives are to further demonstrate the clinical pharmacology of Ceplene by assessing certain immunologic biomarkers in AML patients in first remission, and to measure the effect of Ceplene/IL-2 on minimal residual disease in the same patient population. Secondary objectives will assess leukemia-free survival after a follow-up period of up to two years. EpiCept expects the study will take approximately three years to complete.
EpiCept Corporation Announces Pricing of Public Offering
EpiCept Corporation announced that it has entered into definitive agreements for the purchase of approximately 12.0 million shares of its common stock at $.80 per share and two-and-one-half-year warrants to purchase up to approximately 4.2 million shares of common stock at an exercise price of $.90 per share exercisable beginning December 19, 2009. The offering is expected to close on or about June 23, 2009. EpiCept will receive approximately $8.9 million in net proceeds from the offering. Rodman & Renshaw, LLC, a subsidiary of Rodman & Renshaw Capital Group, Inc. acted as the placement agent for the offering. Net proceeds from the offering will be used to meet working capital needs and for general corporate purposes. EpiCept intends to apply a portion of the net proceeds to fund certain expenses necessary for the previously announced Named Patient Program for Ceplene, the filing of applications for marketing approval of Ceplene in the United States and Canada and to prepare for the commercial launch of Ceplene in the European Union. The proceeds of this offering together with existing cash are expected to be sufficient to fund operations into the second quarter of 2010.
EpiCept Corporation Releases New Data Demonstrating Long Term Durability Of Ceplene In Sustaining Leukemia Free Survival
EpiCept Corporation announced that it has released new long-term data showing that the use of Ceplene when administered in conjunction with low-dose interleukin-2 (IL-2) provides durable protection from leukemia relapse in patients with Acute Myeloid Leukemia (AML), based on a minimum of six years of follow-up. These data will be presented on June 6, 2009 at the European Hematology Association`s (EHA) 14th Congress in Berlin, Germany. The presentation entitled Six-Year Outcomes Update from a Randomized Phase 3 Trial in AML: Durable Effect of Remission Maintenance Immunotheraphy with Histamine Dihydrochloride and low-dose IL-2 was authored by Dr. Mats Brune, MD and co-workers. Researchers analyzed follow-up data from patients enrolled in the Phase III pivotal trial of Ceplene. The primary endpoint assesses the durability of the benefit of Ceplene with IL-2 in achieving leukemia-free-survival (LFS), after a minimum of six years, in patients who have achieved first complete remission (CR1) and among the overall patient group. The study found that the Ceplene/IL-2 treatment group continued to show statistically significant differences in LFS in the overall treatment population (p=0.011) and among the CR1 group (p=0.015).
