Endocyte Shares Plunge After Ovarian Cancer Drug Trial Halted - Update

(RTTNews) - Shares of Endocyte Inc (ECYT) plunged 62 percent on Friday after the biopharmaceutical company, along with Merck & Co Inc (MRK), disclosed that an independent data safety monitoring board called a halt to a late-stage trial of its ovarian cancer drug vintafolide.

The safety monitoring board, upon completion of a pre-specified, interim futility analysis of the PROCEED trial for vintafolide, found the drug did not show efficacy on the pre-specified outcome of progression-free survival in patients with platinum-resistant ovarian cancer.

As a result, the companies have taken steps to notify investigators that screening and randomization of participants in the PROCEED trial will be suspended.

The safety monitoring board did not identify any safety concerns for the patients enrolled in the trial.

PROCEED is a Phase 3 randomized, double-blind clinical trial, evaluating vintafolide in combination with pegylated liposomal doxorubicin (PLD) compared with PLD plus placebo for the treatment of folate receptor-positive, platinum-resistant ovarian cancer.

In March, European regulators granted conditional approval to vintafolide (Vynfinit) for ovarian cancer based on data from a phase-2 study, and today's announcement raises concerns on that decision too.

Vintafolide is an investigational conjugate of folic acid linked to an anti-cancer agent, the potent vinca alkaloid desacetylvinblastine hydrazide. The drug is also being studied in lung cancer.

Last month, shares of West Lafayette, Indiana-based Endocyte surged after it said that a mid-stage trial of vintafolide showed the drug in combination with approved treatment slowed lung cancer progression longer than the single-drug treatment.

Endocyte stock is trading at $6.65, down $10.73 or 61.74%, on a volume of 12.7 million shares on the Nasdaq. Merck stock is trading at $58.24, down $1.38 or 2.31%, on a volume of 5.4 million shares.