CytRx plans Phase 2 clinical trial of its doxorubicin prodrug for advanced gastric cancer

Nov 18 2009

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company, today announced plans to initiate an open-label, multinational Phase 2 clinical trial with its doxorubicin prodrug INNO-206 as a second-line treatment in patients with advanced gastric (stomach) cancer.

CytRx President and CEO Steven A. Kriegsman said, “This planned clinical trial is a key step forward in our plans to build a commercial oncology franchise for CytRx. We have studied the oncology market in solid tumors and believe that stomach cancer represents a major market and an unmet medical problem worldwide. We have also been encouraged by exciting animal data for INNO-206 in a broad array of cancer indications, and are hopeful that this carefully-designed study will bring hope to the sufferers of advanced gastric cancer.”

Fifty patients with gastric cancer who have failed other treatments, including surgery and chemotherapy with drugs other than doxorubicin (anthracyclines), will receive INNO-206 approximately every three weeks for four treatment cycles. The Phase 2 clinical trial will evaluate overall tumor response and progression-free survival in these patients and, based on the initial results, an additional 25 patients could be enrolled. The trial is expected to be conducted in approximately 15 to 20 clinical sites in the United States, Europe, India and the Far East. Following trial initiation, recruitment of all patients is expected within approximately 12 months. Because the clinical trial will be open label, CytRx will be able to review data from the study on an ongoing basis.

“Relapsed or refractory stage 4 gastric cancer is virtually fatal, with median survival less than six months and a five-year survival rate of less than 5%, even in clinical studies that have shown positive results,” said CytRx Chief Medical Officer Daniel Levitt, MD, Ph.D. “Several chemotherapy regimens have been explored as palliative therapy for patients with advanced gastric cancer. Among these, combinations of fluoropyrimidines, platinum analogs and anthracyclines appear to achieve median survival in the range of nine to 10 months in previously untreated patients. Studies in mice with a wide variety of human tumors have demonstrated a significant degree of efficacy of INNO-206 in both preventing tumor growth and shrinking tumors far better than doxorubicin alone. Clinical results indicate that our INNO-206 has a reduced adverse event profile compared to doxorubicin, and replacing epirubicin or doxorubicin with INNO-206 may improve the activity of the treatment regimen without increasing its toxicity.”