Progenics Pharmaceuticals is taking over full responsibility for its GMKand MGV cancer vaccine programs both of which had previously been licensed to Bristol-Myers Squibbs under an agreement signed four years ago. Under the terms of the terminated deal, Progenics receives a final payment of $15.5 million and all rights to the products. Progenics president, Ronald Prentki, said: "our collaboration with Bristol-Myers Squibb has been productive, allowing us to advance GMK into two pivotal Phase III trials."
Progenics has announced its intention to press on with the development of the vaccines, and has just initiated the largest-ever Phase III study of GMK, which is composed of the ganglioside antigen GM2 combined with an immunogenic carrier protein (KLH) and adjuvant (QS-21), for preventing relapse in patients with recurrent malignant melanoma. Individuals who have undergone surgery for melanoma will receive either 14 doses of GMK over a three-year period, or close monitoring without treatment, followed by approximately two years of follow up.
Progenics is also continuing to monitor patients from an ongoing Phase III clinical trial which is comparing GMK to high-dose alpha interferon therapy in melanoma patients with more extensive disease who are at high risk of relapse. This trial was hit last year after oncologists pulled out of the protocol after conducting an unplanned early analysis which indicated that the relapse-free and overall survival rates of GMK-treated patients were lower than those for patients who received alpha interferon (Marketletter June 5, 2000), although the company contested this view on the basis that the follow-up period was too short. Meanwhile, the MGV product remains in earlier development with potential utility in a range of cancers.
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