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
A phase II study intended to provide histological evidence ofclinical response to a new injectable gel product for prostatecancer patients was recently announced by Matrix Pharmaceuticals,Inc. IntraDose-CDDP injectable gel is designed to provide local,sustained administration of cisplatin, and to serve as a minimallyinvasive, nonsurgical outpatient procedure for the treatment ofthe disease.
Patients with prostate cancer who are scheduled for surgical removalof their prostates will receive three treatments with IntraDose-CDDPover a period of 6 weeks prior to surgery. The study is expectedto enroll approximately 15 patients. Examination of the excisedprostates will provide information on histological response, drugdistribution, safety, and intraprostatic dose requirements. Thiswill help define the product's efficacy and the patient populationthat might benefit most from such treatment.
"Initial clinical data from a phase I/II safety and doseescalation study with IntraDose-FU have supported our belief thatour IntraDose products are capable of providing release of potentanticancer agents within the prostate, potentially making thesechemotherapeutics effective in treating this disease for the firsttime," said Craig R. McMullen, president and chief executiveofficer of Matrix.
IntraDose-CDDP injectable gel has been tested in phase I/II clinicaltrials, and Matrix plans to advance the product into phase IIItesting for the treatment of head and neck cancer and superficiallyaccessible 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 froma murine study of squamous cell carcinomas and fibrosarcomas.Study results, they say, demonstrated that the product enhancedintratumoral drug retention, and lowered systemic exposure tocisplatin. Measurable radiolabelled platinum was present in treatedtumors 72 hours following administration, compared with no detectabledrug in the controls after 2 hours.