Allos Therapeutics, Inc. (Nasdaq: ALTH) has initiated the pivotal multi-center Phase 2 study of its unique next generation antifolate PDX (pralatrexate) with vitamin B12 and folic acid supplementation in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
The said phase 2 study, dubbed PROPEL (Pralatrexate in Patients with Relapsed Or Refractory Peripheral T-cell Lymphoma), is an international, multi-center, open-label, single-arm study that will seek to enroll 100 evaluable patients with relapsed or refractory PTCL who have progressed after at least one prior treatment.
According to Paul L. Berns, President and Chief Executive Officer of Allos Therapeutics, Inc.:
"The initiation of this pivotal trial is an important milestone in the development of PDX and has the potential to be a significant driver of the company's future growth.
Clinical experience to date suggests that PDX has the potential to provide meaningful therapeutic benefit to a difficult to treat, drug resistant patient population with high unmet medical need."
This pivotal phase 2 study primarily seeks an objective response rate (complete and partial) and secondly, duration of response, progression-free survival and overall survival.
Find more details at the press release.
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