Clinical Trial :: Paving the way for future pan-European clinical trials

Pan-European collaboration is important for many clinical trials and essential for trials that are investigating treatments for rare diseases. That was the message delivered today by the European Medical Research Councils (EMRC), the membership organisation for medical research councils across Europe based at the European Science Foundation (ESF) in Strasbourg, which is coordinating two trials in rare diseases and about to launch a review of how best to implement clinical trials that are initiated by investigators.

Cancer :: CTRC enrolls first patients in Novel Phase II study for sarcoma — Living virus destroys cancer cell

The Cancer Therapy & Research Center Institute for Drug Development, in collaboration with Oncolytics Biotech Inc., a biotechnology company, has enrolled the first two patients in a new Phase II clinical study for patients with various types of sarcomas that have metastasized to the lung.

Osteosarcoma :: FDA reviews IDM Pharma’s Junovan for treatment of osteosarcoma

IDM Pharma, Inc. (NASDAQ: IDMI) announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 to 2 that the results of INT 0133, the Phase 3 trial, do not provide substantial evidence of effectiveness of Junovan (mifamurtide) in the treatment of patients with non-metastatic, resectable osteosarcoma receiving combination chemotherapy.

Sarcoma :: Researchers find that childhood sarcoma increases risk of blood clots

Researchers at the National Cancer Institute (NCI), part of the National Institutes of Health, have determined that children and young adults with a form of cancer called sarcoma are at increased risk of having a thromboembolic event (TE) in their veins. Thromboembolic events can be a blood clot in a vessel that can interfere with normal blood flow.

Osteosarcoma :: IDM Pharma’s Mepact, mifamurtide – Junovan in the Treatment of Osteosarcoma

IDM Pharma (NASDAQ:IDMI) announced today that the company has submitted a Marketing Authorization Application (MAA) in eCTD format (electronic common technical document) to the European Medicines Agency (EMEA) for Mepact (mifamurtide for injection), requesting approval for its use in the treatment of patients with newly diagnosed resectable high-grade osteosarcoma following surgical resection in combination with post-operative multi-agent chemotherapy. This announcement follows the October 25, 2006 submission of a New Drug Application (NDA) for Junovan (mifamurtide for injection) to the Food and Drug Administration (FDA) in the United States.