By Kim Coghill
Progenics Pharmaceuticals Inc. said it will continue development of two cancer vaccine programs that it has reacquired from Bristol-Myers Squibb Co.
Progenics, of Tarrytown, N.Y., said in a joint decision with Bristol-Myers Squibb that the companies agreed to terminate their collaborative agreement for the development of GMK and MGV cancer vaccines. Progenics will receive $15.5 million and regain all rights to the products.
¿We remain optimistic regarding the commercial and clinical potential of GMK and MGV,¿ said Richard Krawiec, vice president of investor relations and corporate communications at Progenics. ¿We are grateful to Bristol-Myers Squibb for supporting us and advancing this vaccine [GMK] to two Phase III trials. Now that we have regained the rights, we plan to continue uninterrupted clinical development of the programs as planned. The funds we¿ve received from Bristol-Myers Squibb will allow us to continue these programs.¿
Krawiec said Progenics noted in previous SEC filings that Bristol-Myers Squibb, of Princeton, N.J., had considered the GMK and MGV projects on hold. ¿But it has always been our desire to continue development of these products,¿ he said.
Progenics has started an international Phase III clinical trial of GMK to prevent the relapse of malignant melanoma in patients who have Stage II (intermediate-risk) disease. Currently there are no approved therapies following surgery for these patients.
The study is being conducted with the European Organization for Research and Treatment of Cancer (EORTC).
The GMK vaccine is designed to stimulate a patient¿s immune system to control or eradicate residual cancer cells after the tumor has been resected. GMK incorporates the GM2 ganglioside, a cancer antigen found in about 95 percent of melanoma cells.
Progenics¿ stock took a major hit last year when an early, unplanned analysis of GMK in high-risk patients enrolled in a Phase III trial showed that patients receiving GMK did not do as well as those receiving high-dose alpha-interferon. The analysis was of a subset of 880 patients enrolled in the trial.
The day the information was publicized, Progenics¿ stock (NASDAQ:PGNX) dropped 70 percent to close at $10, down $23.06. Progenics closed Tuesday at $14.06, down 39 cents.
¿We believe that data was premature when they looked at it last May,¿ Krawiec said.
The Phase III trial in high-risk patients is ongoing and expected to be completed later this year.
The EORTC Phase III trial will include an anticipated enrollment of 1,300 patients who are at intermediate risk for recurrence of the disease. The study will recruit patients from Europe as well as Australia. EORTC will randomize patients after surgery to receive either GMK or the current standard of care, which is no treatment but close monitoring. Patients on the vaccine arm of the study will receive 14 doses of GMK over three years, with an estimated two years of additional follow-up.
In other business, Progenics is evaluating other forms of cancer in which to appropriately test MGV.
The company has several other products in the pipeline and at various stages of development.
Its lead HIV product, PRO 542, a viral-entry inhibitor, is in Phase II clinical trials. Meanwhile, the company is developing follow-on product candidates in HIV infection. PRO 367 has completed a Phase I study, PRO 140 is preparing to start Phase I/II trials, and a lead therapeutics candidate has been selected from a novel class of anti-HIV compounds known as sulfated CCR5 peptides.
In another agreement, Progenics and F. Hoffmann-La Roche Ltd., of Basel, Switzerland, in April renewed their three-year collaboration to discover and develop novel HIV therapeutics. The goal is to identify drugs that target HIV co-receptors ¿ molecular structures on the cell membrane that are used by the virus to gain entry into the cell.