A phase II study intended to provide histological evidence of clinical response to a new injectable gel product for prostate cancer patients was recently announced by Matrix Pharmaceuticals, Inc. IntraDose-CDDP injectable gel is designed to provide local, sustained administration of cisplatin(Drug information on cisplatin), and to serve as a minimally invasive, nonsurgical outpatient procedure for the treatment of the disease.
Patients with prostate cancer who are scheduled for surgical removal of their prostates will receive three treatments with IntraDose-CDDP over a period of 6 weeks prior to surgery. The study is expected to enroll approximately 15 patients. Examination of the excised prostates will provide information on histological response, drug distribution, safety, and intraprostatic dose requirements. This will help define the product's efficacy and the patient population that might benefit most from such treatment.
"Initial clinical data from a phase I/II safety and dose escalation study with IntraDose-FU have supported our belief that our IntraDose products are capable of providing release of potent anticancer agents within the prostate, potentially making these chemotherapeutics effective in treating this disease for the first time," said Craig R. McMullen, president and chief executive officer of Matrix.
IntraDose-CDDP injectable gel has been tested in phase I/II clinical trials, and Matrix plans to advance the product into phase III testing for the treatment of head and neck cancer and superficially accessible tumors, such as melanoma, recurrent breast cancer, and squamous cell carcinoma, in the second quarter of 1995. Recently, at the American Association for Cancer Research Meeting in Toronto, the company presented data for IntraDose-CDDP injectable gel from a murine study of squamous cell carcinomas and fibrosarcomas. Study results, they say, demonstrated that the product enhanced intratumoral drug retention, and lowered systemic exposure to cisplatin. Measurable radiolabelled platinum was present in treated tumors 72 hours following administration, compared with no detectable drug in the controls after 2 hours.