WESTMINSTER, Colo., Nov. 12 Allos Therapeutics,Inc. (Nasdaq: ALTH) today announced the initiation of patient enrollment in aPhase 1, non-randomized, open-label, multi-center dose escalation study of theCompany's targeted chemotherapeutic agent RH1 in patients with advanced solidtumors or non-Hodgkin's lymphoma (NHL).
"We are pleased to advance the development of this agent," said Pablo J.Cagnoni, M.D., Chief Medical Officer of Allos. "RH1 is a small moleculechemotherapeutic agent that is bioactivated by the enzyme DT-diaphorase (DTD),which is over-expressed in many tumors, including lung, colon, breast andliver tumors. We believe that because RH1 is bioactivated in the presence ofDTD, it has the potential to preferentially target certain tumors whilelimiting the amount of toxicity to normal tissue."
In this study, patients with either advanced solid tumors or NHL willreceive a 3-hour intravenous (IV) infusion of RH1 administered once every 21days. Patients will receive starting doses of RH1 at 1.5 mg/m2, with doseescalation in subsequent cohorts based on toxicity. Up to 60 evaluablepatients will be enrolled in the study with the objective of determining themaximum tolerated dose (MTD), recommended Phase 2 dose and safety profile ofRH1 in this population. Three to six patients will be enrolled per cohort.An expanded cohort of up to 24 evaluable patients who have tumor types with ahigh likelihood of DTD over-expression will be recruited to explore possiblemarkers of anticancer activity. D. Ross Camidge, M.D., Ph.D., AssistantProfessor of Medical Oncology at the University of Colorado Cancer Center,will serve as the study chair.
Information regarding this study is available at http://www.allos.com orthe U.S. government's clinical trials database athttp://www.clinicaltrials.gov.
About Non-Hodgkin's Lymphoma
Non-Hodgkin's lymphoma (NHL) is the most common hematological cancer andthe fifth leading cause of cancer death in the U.S. An estimated 63,000 newcases of NHL will be diagnosed each year, of which peripheral T-cell lymphomarepresents approximately 10 percent.
About Allos Therapeutics, Inc.
Allos Therapeutics, Inc. (ALTH) is a biopharmaceutical company focused onthe development and commercialization of small molecule therapeutics for thetreatment of cancer. The Company's lead product candidate, PDX (pralatrexate),is a novel antifolate currently under evaluation in a pivotal Phase 2 (PROPEL)trial in patients with relapsed or refractory peripheral T-cell lymphoma. ThePROPEL trial is being conducted under an agreement reached with the U.S. Foodand Drug Administration under its special protocol assessment, or SPA process.The Company is also investigating PDX in patients with non-small cell lungcancer and a range of lymphoma sub-types. The Company's other productcandidate is RH1, a targeted chemotherapeutic agent that is currently beingevaluated in a Phase 1 study in patients with advanced solid tumors ornon-Hodgkin's lymphoma. For additional information, please visit the Company'swebsite at http://www.allos.com.
Safe Harbor Statement
This press release contains forward-looking statements that are madepursuant to the safe harbor provisions of the Private Securities LitigationReform Act of 1995. Such forward-looking statements include statementsrelating to the potential safety and efficacy profile of RH1 for the treatmentof advanced solid tumors, non-Hodgkin's lymphoma or any other type of cancer;the potential of RH1 to preferentially target certain tumors while limitingthe amount of toxicity to normal tissue; and other statements that are otherthan statements of historical facts. In some cases, you can identifyforward-looking statements by terminology such as "may," "will," "should,""expects," "intends," "plans," anticipates," "believes," "estimates,""predicts," "projects," "potential," "c