CytRx To Initiate Phase 2 Clinical Trial With INNO-206 In Patients With Advanced Gastric Cancer

Main Category: Cancer / Oncology
Also Included In: GastroIntestinal / Gastroenterology;  Clinical Trials / Drug Trials
Article Date: 19 Nov 2009 - 6:00 PST

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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."

About INNO-206

CytRx holds the exclusive worldwide rights to INNO-206, a prodrug derivative of the commonly prescribed chemotherapeutic agent doxorubicin. INNO-206 is designed to reduce adverse events by controlling drug release and preferentially targeting tumors. In a Phase 1 clinical trial, INNO-206 was administered in doses at up to six times the standard dosing of doxorubicin without an increase in observed side effects over those historically seen with doxorubicin. In the Phase 1 clinical trial of 35 patients with various cancers treated with INNO-206, three patients showed a partial tumor reduction and 20 patients showed stable disease over the course of the trial. All three of the partial responses occurred at the higher dose ranges of the dose-ranging safety study. Animal studies conducted by INNO-206 inventor Dr. Felix Kratz, Department of Medical Oncology, Clinical Research, at the Tumor Biology Center in Freiburg, Germany, demonstrated statistically significant results in breast, ovarian, pancreatic and small cell lung cancers. Results of these studies were published in the peer-reviewed journal Investigational New Drugs.

About Gastric Cancer

Although gastric cancer (adenocarcimona of the stomach) is the tenth leading malignancy worldwide, it is the second leading cause of cancer death with approximately 800,000 reported each year. In the U.S., approximately 21,000 cases of gastric cancer are diagnosed each year and more than 10,000 deaths are attributable to this disease. Gastric cancer occurs with greatest frequency in the Far East, particularly in Japan and South Korea, as well as in South America and certain European countries. A number of risk factors have been identified and include familial adenomatous polyposis, gastric adenomas or high grade dysplasia, chronic atrophic gastritis, Helicobacter pylori infection, pernicious anemia and tobacco smoking. Possible risk factors are excess alcohol ingestion, high intake of salted, pickled or smoked foods, Peutz-Jeghers Syndrome and gastric ulcers.

Source
CytRx Corporation