19 Sep 2007 03:00 AM
EpiCept Reports Regulatory Progress On Ceplene(TM)
EbpiCept Corporation
(Nasdaq and OMX Nordic Exchange: EPCT) reported that the assessment
of its European Union centralized marketing authorization application for
its lead oncology product Ceplene(TM) is advancing according to the
anticipated regulatory timetable following a meeting yesterday. Ceplene
(histamine dihydrochloride) has demonstrated important clinical benefit in
the maintenance of remission for patients with Acute Myeloid Leukemia
(AML).
EpiCept's Marketing Authorization Application (MAA) for Ceplene has reached the next important step in its assessment by the Committee for Human Medicinal Products (CHMP). Specifically, EpiCept submitted full responses to the Day 120 Consolidated List of Questions. EpiCept's staff and expert consultants met on September 17 with EMEA officials and CHMP representatives to discuss these responses. Included with the Day 120 response documentation, EpiCept has provided data on Ceplene's effect on quality of life and on long term follow up of at least five years on leukemia-free survival for AML patients.
"We are pleased to have reached the latest regulatory milestone for Ceplene in the EU, and to be closer to our goal of providing hematologists with the first remission maintenance immunotherapy for AML patients," stated Jack Talley, President and Chief Executive Officer of EpiCept. "EpiCept outlined to the EMEA and CHMP representatives how the data package for Ceplene supports approval. We look forward to working with the regulators to complete their assessment. We are enthusiastic about the potential of Ceplene, which in our pivotal trial increased the long-term, disease-free survival of AML patients by more than 50%. Importantly, this significant therapeutic benefit was achieved with a remarkably well-tolerated, self-administered immunotherapy."
EpiCept's MAA submission for Ceplene is being assessed under the EU centralized procedure, and if approved, will provide a marketing authorization valid in all EU member states, along with Iceland, Liechtenstein and Norway. The European Commission has previously granted orphan drug status to Ceplene for use in the treatment of AML. If the application for Ceplene continues to follow usual EU regulatory timelines, the next milestone on Ceplene's path to approval is expected to be the CHMP Day 180 list of outstanding…
EpiCept's Marketing Authorization Application (MAA) for Ceplene has reached the next important step in its assessment by the Committee for Human Medicinal Products (CHMP). Specifically, EpiCept submitted full responses to the Day 120 Consolidated List of Questions. EpiCept's staff and expert consultants met on September 17 with EMEA officials and CHMP representatives to discuss these responses. Included with the Day 120 response documentation, EpiCept has provided data on Ceplene's effect on quality of life and on long term follow up of at least five years on leukemia-free survival for AML patients.
"We are pleased to have reached the latest regulatory milestone for Ceplene in the EU, and to be closer to our goal of providing hematologists with the first remission maintenance immunotherapy for AML patients," stated Jack Talley, President and Chief Executive Officer of EpiCept. "EpiCept outlined to the EMEA and CHMP representatives how the data package for Ceplene supports approval. We look forward to working with the regulators to complete their assessment. We are enthusiastic about the potential of Ceplene, which in our pivotal trial increased the long-term, disease-free survival of AML patients by more than 50%. Importantly, this significant therapeutic benefit was achieved with a remarkably well-tolerated, self-administered immunotherapy."
EpiCept's MAA submission for Ceplene is being assessed under the EU centralized procedure, and if approved, will provide a marketing authorization valid in all EU member states, along with Iceland, Liechtenstein and Norway. The European Commission has previously granted orphan drug status to Ceplene for use in the treatment of AML. If the application for Ceplene continues to follow usual EU regulatory timelines, the next milestone on Ceplene's path to approval is expected to be the CHMP Day 180 list of outstanding…
