Thursday, May 6, 2010

Orphan status granted for ovarian cancer drug

QUEBEC CITY(Cancer Digest) – Canadian drug maker Aeterna Zentaris Inc. has been granted orphan drug status for its late-stage ovarian cancer drug AEZS-10. The drug is a hybrid that combines a molecule that naturally binds to a particular protein receptor displayed on a cell surface  with a cell-killing agent. In this case the molecule, which prefers to binds to the protein receptor called, luteinizing hormone-releasing hormone, or LHRH, is combined with the chemotherapy agent doxorubicin.

The goal is to use the molecule like a delivery truck to carry the toxic chemotherapy specifically to cells that produce a lot of LHRH receptors, as certain types of ovarian cancer tumors do. By targeting tumor cells more specifically, it is hoped the drug will prove effective in shrinking tumors while being less toxic to normal tissues.

In an early stage clinical study of 43 ovarian cancer patients presented at the 2007 annual meeting of the American Society of Clinical Oncology’s (ASCO), the drug was shown to affect tumor growth in seven out of 13 patients treated with a therapeutic dose, including three patients with complete or partial response to the drug. A complete response is elimination of the tumor for at least four weeks, partial response is a 50 percent or more reduction of the tumor for that long. That trial is ongoing and is expected to be completed at the end of this year.

Orphan-drug designation is granted for new drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a package of financial incentives and tax credits as well as a waiver of certain fees that are normally required for gaining FDA approval, which might otherwise  deter the development of promising treatment strategies.

More information about the ongoing clinical trial is available at:

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