Kahalalide F enters Phase II trials
Kahalalide F, from PharmaMar, has begun Phase II trials in non-small cell lung cancer (NSCLC) and in melanoma.
Kahalalide F, from PharmaMar, has begun Phase II trials in non-small cell lung cancer (NSCLC) and in melanoma.
These trials are based on the strength of Phase I results when this compound showed a very favourable safety profile and clinical benefit in NSCLC and melanoma as well as in a broad spectrum of tumour types.
The NSCLC PII trial is a multicentre open label study of Kahalalide F (KF) in patients who have relapsed or progressed after first line chemotherapy. KF will be administered weekly at a dose of 0.65mg/m2 in a one-hour infusion. 25 patients will be included in the first instance with the potential to increase this to 34 patients. 12 European hospitals will participate in this clinical trial. The primary end point is response rate. Secondary objectives are the evaluation of the pharmacokinetics and further investigation of the safety profile of the product.
The PII melanoma trial is an open label study of KF as a one-hour weekly infusion in patients with advanced malignant melanoma. KF will be administered at a dose of 0.65mg/m2. 18 patients will be included in the first stage of the trial, potentially increasing to 32 patients. The trial will be conducted in 12 European centres. The primary end point is response rate. Secondary end points will evaluate the pharmacokinetics and safety profile of the product.
There is no standard treatment for patients with metastatic melanoma. Treatment options include the surgical resection of isolated metastases, therapy with dacarbazine, combination chemotherapy and immunotherapy. However, response rates associated with these measures range between 15% and 20%, hence the urgent need for the development of new therapies.
Dr Miguel Angel Izquierdo, director of clinical development at PharmaMar, said: 'The clinical benefit seen in the Phase I trials both in melanoma and NSCLC justify the beginning of these new Phase II trials. In addition, we are encouraged by the exceptional safety profile of Kahalalide F which has allowed the continuous administration of the drug for up to 20 months in patients showing clinical benefit.'