Clinical news from Datamonitor
pharmafile | May 17, 2007 | News story | Research and Development |Â Â Â
FDA requests additional efficacy data for Dendreon's Provenge in advanced prostate cancer.
Dendreon has received a complete response letter from the FDA requesting additional efficacy data for Provenge in advanced asymptomatic hormone refractory prostate cancer. This is particularly disappointing given the high unmet needs that remain for this indication coupled with the heightened anticipation that surrounds a potential approval of the first therapeutic cancer vaccine.
Provenge (sipuleucel-T) is an investigational product that may represent the first in a new class of active cellular immunotherapies that are uniquely designed to stimulate a patient's own immune system.
The application for Provenge was based on results from a randomized placebo-controlled phase III trial, which showed that patients with asymptomatic metastatic hormone refractory prostate cancer (HRPC) who received Provenge had a median survival time of 4.5 months longer than those in the placebo arm. The vaccine also demonstrated a 41% overall reduction in the risk of death. In addition, 34% of patients receiving Provenge were still alive 36 months after treatment compared to only 11% of patients randomized to receive placebo.
Prostate cancer is the third most common cancer worldwide. In the US alone, more than one million men have the disease, with an estimated 232,000 new cases diagnosed each year. More than 30,000 men die each year from prostate cancer. To date, no therapeutic cancer vaccine has achieved US approval and the fact that Provenge had received priority review status is a reflection of the high unmet need within the prostate cancer market.
The FDA's request was arguably unexpected, having acted against the recommendation of an advisory panel which voted 17-0 that the drug was safe, and 13-4 that the compound was substantially effective and should be approved. However, upon closer inspection, the outcome is less surprising. Much of the support for the drug came from the biologic and vaccine side of the FDA whereas regulators on the drug side of the agency, especially those who oversee review and approval of cancer drugs, were certainly more skeptical about Provenge.
It is difficult to speculate what Dendreon needs to do to get Provenge back on track and the company is currently seeking clarification about what type of data the FDA requires. If new data from an ongoing phase III trial is required, the vaccine may have to wait two to three years before approval is realized. With no precedent for approval of a cancer vaccine, and with increased potential competition from pipeline products, Dendreon is now unlikely to become the first company to bring a therapeutic cancer vaccine to market.
Biogen and Vernalis start Parkinson's trial
Biogen Idec and Vernalis have initiated a phase II program of oral compound BIIB014 for the treatment of Parkinson's disease.
The initial phase II study will test single and repeated doses of BIIB014 in patients with late-stage Parkinson's disease, in addition to the usual L-dopa therapy. The second phase II study will be a trial of BIIB014 monotherapy in patients with early-stage Parkinson's disease. The primary endpoint of both studies will be to evaluate the safety and tolerability of BIIB014. Secondary endpoints will include the evaluation of motor function.
Simon Sturge, CEO of UK biotech firm Vernalis, said: "The progress into phase II trials is of particular significance to Vernalis' growing Parkinson's disease franchise and further demonstrates the company's ongoing commitment to the Parkinson's community."
Vernalis received a milestone payment of $3 million at the end of 2006 relating to the start of the phase II program from Biogen.
Array BioPharma initiates clinical trials of cancer drug
Array BioPharma has initiated dosing cancer patients in a phase I clinical trial with ARRY-520, a targeted small molecule anticancer drug.
ARRY-520 is a potent kinesin spindle protein inhibitor that caused marked tumor regression in preclinical models of human cancer at tolerated doses, often leading to complete, durable responses.
The trial, which will be conducted in the US, is designed to evaluate the safety, tolerability and pharmacokinetics of ARRY-520 following intravenous administration to patients with advanced cancer. In addition, the trial will examine indicators of therapeutic activity in these patients.
Kevin Koch, president and chief scientific officer, said: "We are pleased that ARRY-520 has advanced to the stage of treated cancer patients in a phase I clinical trial. We are looking forward to continued progress on ARRY-520, as well as our other nine development programs, during 2007."
