At the recent year-end call Allos Therapeutics (NASDAQ: ALTH) reported financial and developmental 2007 highlights. As-of 31 December the company had a cash and cash equivalent position of $57.8M on hand, the coffers were achieved primarily via a 1Q07 9M common share offering that raised just north of $50M. With a quarterly burn of approximately $11M management believes they are well positioned through 1Q09.
For PDX (pralatrexate) an interim safety analysis for the PROPEL study was completed that supported the continuation of the trial, and received orphan medicinal product designation for the treatment of patients with peripheral T-cell lymphoma from the Commission of the European Communities. This designation complements the orphan drug and fast track designations previously granted for the treatment of patients with T-cell lymphoma by the FDA. Additional solid tumor and lymphoma trials have been enrolling including a Phase IIb study of PDX versus Genentech’s (NYSE: DNA) and OSI Pharma's (NASDAQ: OSIP) Tarceva® in patients with Stage IIIB/IV non-small cell lung cancer who are or have been cigarette smokers, who have failed treatment with at least one prior platinum-based chemotherapy regimen. As well as ongoing enrollment in a Phase I/IIa study of PDX and gemcitabine with vitamin B12 and folic acid supplementation in patients with relapsed or refractory non-Hodgkin's lymphoma. And a Phase I study of PDX with vitamin B12 and folic acid supplementation in patients with relapsed orrefractory cutaneous T-cell lymphoma. And, for the RH1 asset, a Phase I study of patients with advanced solid tumors or non-Hodgkin's lymphoma was initiated.
Setting the Stage for 2008:
The Company currently has six ongoing clinical trials involving PDX, including the PROPEL trial, evaluating the compound's potential clinical utility in hematologic malignancies and solid tumor indications. Looking at 2008 Allos intends to complete enrollment in PROPEL by 2Q08 and plans to report top-line results of the trial by 4Q08. If the results are positive management anticipates filing for regulatory approval to market PDX for the treatment of peripheral T-cell lymphoma. Management may initiate an additional Phase II single-agent study in another solid tumor indication in 1H08 and an additional Phase I combination study in solid tumor indications by year end.
Architecting for success includes execution of product launch planning. Allos retains exclusive worldwide rights to PDX for all indications and intends to commercialize PDX, if approved for marketing, by building an oncology focused US sales and marketing organization. Hoping for nothing but the best for Allos in 2008, may be a seminal year in the history of the company!
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