Poniard’s Picoplatin, Showing Positive Interim Survival Results from Ongoing Phase 2 Trial for Small Cell Lung Cancer
The trial includes SCLC patients with platinum-refractory disease or platinum-resistant or platinum-sensitive disease who have progressed within six months after receiving first-line therapy.
Poniard will base from the above clinical data its plans to initiate a pivotal Phase 3 trial of picoplatin in SCLC in the first half of 2007 and file a New Drug Application for this indication in 2009.
According to John R. Eckardt, M.D., a Phase 2 clinical trial investigator and medical oncologist at The Center for Cancer Care and Research in St. Louis:
"SCLC presents a critical unmet medical need with inadequate treatment options. Platinum-resistant or -refractory SCLC patients often experience rapid disease progression and low overall survival despite treatment with available drugs, which have significant associated toxicities."
Picoplatin is a new generation platinum therapy with an improved safety profile designed to overcome and prevent platinum resistance associated with chemotherapy in solid tumors.
For nearly ten years, the USFDA has not approved new drugs for the treatment of platinum-resistant or –refractory SCLC.
Find more details from the press release.
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