Allos Therapeutics (ALTH) recently released data on Folotyn (pralatrexate injection) from the PROPEL trial, which was conducted with patients suffering from relapsed or refractory peripheral T-cell lymphoma (PTCL). In addition, the company announced preliminary results from its phase 1/2 study of Folotyn in combination with gemcitabine for the treatment of patients with relapsed or refractory lymphoproliferative malignancies. The data were presented at the 51st Annual Meeting of the American Society of Hematology (ASH) in New Orleans.

Earlier, in September 2009, Folotyn received accelerated approval from the US Food and Drug Administration (FDA) for the treatment of patients with relapsed or refractory PTCL. Following the approval, Folotyn became Allos’ first drug to receive FDA approval.

This was a major breakthrough for the company as prior to Folotyn, there was no approved drug for this disease. Although the drug has been made available to patients since October, the commercial launch is scheduled for January 2010.

Data presented at the meeting included an update of overall response rate for Folotyn. The overall response rate was 29% (32 of 109 evaluable patients) with 63% of the patients responding within the first cycle of therapy. While the median duration of response was 10.1 months, median overall survival was 14.5 months.

In another development, Allos entered into a collaborative agreement with UK-based Idis, for conducting the named patient program for Folotyn outside the US. As per the terms of the agreement, Idis will be the exclusive supplier of the drug to health care providers outside the US under the program.

Since its inception in 1992, Allos has not generated any revenue from product sales and has experienced significant net losses and negative cash flows from operations. The successful launch and marketing of the drug in due course should boost the company’s top line. We have a Neutral recommendation on the stock.

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