In October 2006, Peregrine announced plans to start a 40-patient phase II study of Cotara in India.
In March 2009, Peregrine conceded enrollment in both the phase I and phase II studies of Cotara was "modest," forcing the company to place the entire program on the backburner due to financial constraints.
It wasn't until June 2010 that "final data" on 12 patients in the phase I dosing study of Cotara were released.
During the same month, Peregrine announced the phase II study of Cotara in India was 75% enrolled. Mind you, that means it took the company four years to enroll 30 GBM patients in India.Final results from the phase II study were finally presented in June 2011 -- five years after the study started. All the data is from Indian patients with recurrent GBM. The study was single arm and open label. The median overall survival was reported to be 8.8 months with a median progression-free survival of 23 weeks. Without a comparator arm, the data are meaningless, particularly since the trial was conducted entirely in India over five years. "Our goal going into these discussions with the FDA was to agree upon a clinical trial design that would be appropriate for this orphan indication and one which we could enroll within a two-year timeframe," said Joseph Shan, Peregrine's vice president of clinical and regulatory affairs, in Wednesday's press release. Wait. Peregrine claims it will enroll 300 GBM patients in a Cotara phase III trial within two years. Wow, that's funny, given the five-plus years it took to enroll 40 patients in India! "Having established a clear clinical path forward for this novel and targeted delivered drug candidate, we can now escalate our business development activities to secure a partnership, recognizing the great interest by companies in drug candidates within the orphan and rare disease space," said Peregrine CEO Steven King, also in today's company press release.
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