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"With five PDX trials ongoing and two additional studies scheduled tobegin in the near term, we continue to make important progress advancing thedevelopment of PDX in hematologic malignancies and solid tumors," stated PaulL. Berns, President and Chief Executive Officer of Allos. "PROPEL, our pivotalPhase 2 trial of PDX in patients with relapsed or refractory peripheral T-celllymphoma, is ahead of schedule with completion of patient enrollment expectedin the second quarter of 2008. We look forward to providing future updatesregarding PDX's clinical profile and potential commercial opportunities."
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Pipeline Development Update:
PDX (pralatrexate)
PDX is a novel, small molecule chemotherapeutic agent that inhibitsdihydrofolate reductase, or DHFR, a folic acid (folate)-dependent enzymeinvolved in the building of nucleic acid, or DNA, and other processes. PDX isan investigational drug currently under evaluation in patients with lymphomaand non-small cell lung cancer (NSCLC).
PROPEL
In September 2007, the Company announced the completion of pre-plannedinterim analyses of patient response and safety data from the Company'spivotal Phase 2 PROPEL trial of PDX in patients with relapsed or refractoryperipheral T-cell lymphoma (PTCL). Results of the interim analysis of patientresponse data exceeded the pre-specified threshold for continuation of thetrial, which required a minimum of four responses (complete or partial) out ofthe first 35 evaluable patients, as determined by independent oncology review.In addition, an independent Data Monitoring Committee (DMC) completed aninterim analysis of the safety data from the first 35 evaluable patients andrecommended that the trial continue per the protocol. In accordance with thetrial protocol, the DMC will conduct another interim analysis of safety datafrom the first 65 evaluable patients. The Company expects to report theoutcome of the 65-patient safety analysis by the end of 2007 and completeenrollment in the trial in the second quarter of 2008.
PDX in CTCL
In August 2007, the Company announced the initiation of patient enrollmentin a Phase 1, open-label, multi-center study of PDX with vitamin B12 and folicacid supplementation in patients with relapsed or refractory cutaneous T-celllymphoma (CTCL). Up to 56 evaluable patients will be enrolled in the studywith the objective of determining the optimal dose and safety profile of PDXin this population. A total of 20 of these patients will be enrolled at thedetermined optimal dose and schedule.
PDX in NSCLC (Phase 1)
In October 2007, data from the Company's Phase 1 dose ranging study of PDXwith vitamin B12 and folic acid supplementation in patients with previouslytreated advanced NSCLC were presented at the 2007 AACR-NCI-EORTC conference.In this study, a total of 22 patients with relapsed or refractory NSCLC weretreated at doses of 150 to 325 mg/m2 of PDX. The maximum tolerated dose(MTD) was determined to be 270 mg/m2, which is nearly twice that observed in aprevious Phase 1 study in which PDX was administered without vitaminsupplementation. Clinically si
