Allos Therapeutics, Inc. (ALTH) recently announced data from its ongoing dose-finding early-stage study (n=54) of Folotyn (pralatrexate injection) in patients suffering from relapsed or refractory cutaneous T-cell lymphoma (CTCL). The company presented the data at the European Hematology Association (EHA) meeting in Spain. 

The early-stage dose-finding trial is studying the candidate in relapsed or refractory CTCL patients who have undergone at least one complete prior therapy. The initial phase of the open-label, multi-center study made use of a dose de-escalating strategy to determine an active, well-tolerated dose and schedule of the candidate. The subjects were randomized into various dosing regimens for this purpose.
 
Folotyn administered at 15 mg/m2 weekly for three weeks out of a four-week cycle was established as the optimal starting dose. Of the 29 patients who received Folotyn at the optimal dose, 22 could be evaluated for safety with a response rate of 45%. 23 patients in the optimal dose group were evaluable for safety. Folotyn was generally well tolerated at the optimal dose. Seventeen of 34 patients treated with Folotyn at the optimal dose or higher achieved partial response while one patient achieved complete response. 

CTCL comprises of approximately 2% to 3% of the estimated 66,000 new cases of non-Hodgkin’s lymphoma diagnosed each year in the US, according to data released by the Lymphoma Research Foundation. CTCLs comprise a group of sluggish non-Hodgkin’s T-cell lymphomas, which mainly manifest in the skin. 

Folotyn is already approved by the US Food and Drug Administration (FDA) for treating patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This is the only product of the company to hit the market. The drug received accelerated FDA approval in September 2009. Allos is also eyeing the market outside the US and aims to submit a marketing application later this year in Europe. 

We believe Folotyn’s approval for the PTCL indication will provide major relief to patients suffering from this disease as prior to Folotyn there was no approved drug. While the drug has been available to patients since October, it was launched commercially in January 2010. Recently, the drug received orphan status in the US for bladder cancer. 

The company’s efforts to expand Folotyn’s label into other indications is encouraging. We believe that Folotyn, if approved, for any of the additional indications can prove to be a major revenue earner for the company. 

Currently we are Neutral on Allos Therapeutics.
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