Medivation Inc (NASDAQ:MDVN) has revealed that the FDA has lifted the partial clinical hold on the Investigational New Drug (IND) application for pidilizumab. This has cleared way for the company to proceed with the phase-2 clinical trials of the drug in patients with relapsed large B-cell lymphoma. Added to this, the drug can also be used in other studies that are cross referenced in the IND. Medivation has also clarified that the hold was not related to any safety concerns, during the trial.
MDVN has also revised its brochures, consent documents and protocols to state that programmed death-1 is not a target of the drug. Although the enrollment for the trials had begun in late 2015, but no patients have been enrolled as yet. However, some patients have been receiving the drug through investigator sponsored trials and are expected to continue doing so, but under the revised guidelines.
David Hung, the CEO of Medivation, expressed his delight at the lifting of the ban. He also stated that the company is trying to determine the exact binding mechanism of the drug. The company believes that this mechanism is responsible for triggering the body’s innate response, which differentiates it from the various immuno-oncology drugs in the market. Immuno-oncology drugs tend to target the adaptive side of the immune system.
Apart from initiating the phase-2 clinical trials, Medivation is also making progress with a drug that is already in the market. Xtandi, the company’s alternative to Zytiga, has started to gain ground and is expected to overtake its competitors, in terms of sales, to reach an annual estimate of $5 billion. Although Xtandi has progressed slowly, as compared to the competition, it is finally going head-to-head with Zytiga. Furthermore, a comparison of two similar studies, conducted on the drugs, has revealed a lower death rate in patients taking Xtandi.
Medivation Inc (NASDAQ:MDVN) reached a close at $38.16, at the end of the March 9 trading session, after suffering a loss of 2.48%, in share value.