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news.AmpliMed's lead anticancer drug Amplimexon has been granted orphan drug designation by the FDA in its indication to treat ovarian cancer.
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Preclinical studies have indicated that Amplimexon is effective at killing ovarian cancer cells in doses which can be achieved following administration of the drug to humans. In addition, the drug has been shown to act synergistically with other drugs commonly used to treat ovarian cancer, such as taxotere and platinum-containing anticancer drugs.
Amplimexon has already been granted orphan drug designation for the treatment of metastatic malignant melanoma, multiple myeloma and pancreatic cancer. The drug is currently completing a phase I dose-escalation study to establish safety and tolerability, and phase I/II clinical studies in combination with gemcitabine for the treatment of pancreatic cancer, and in combination with dacarbazine in the treatment of metastatic melanoma.
Orphan drug designation is granted to applicants when the prevalence of the disease is less than 200,000 patients in the US. The benefit of orphan drug designation includes exclusive marketing rights in the US for seven years following marketing approval and enables the company to apply for research funding, tax credits for certain research expenses and a waiver from the FDA’s application user fee. These advantages are intended to encourage sponsors to develop drugs for patients with rare diseases.
22,200 new cases of ovarian cancer are expected in the US in 2005. The disease accounts for nearly 3% of all cancers among women. Current treatment options include surgery, radiation therapy and chemotherapy. Overall, nearly 80% of new ovarian cancer patients survive one year after diagnosis; the five year relative survival rate for all stages is 53%.
“While significant advances in the treatment of ovarian cancer have been made in recent years, the disease often becomes resistant to commonly used therapies,” said Evan Hersh, executive vice president and chief medical officer of AmpliMed. “Our research with Amplimexon has suggested the possibility that the drug may resensitize certain types of ovarian cancer to these therapies and enable patients to experience an extended period of clinical response.”