Vion Pharmaceuticals Enters Into Agreement With HOVON to Conduct a ...

Tag : Pharmaceuticals

NEW HAVEN, Conn., Aug. 19 /PRNewswire-FirstCall/ -- VIONPHARMACEUTICALS, INC. announced today that it had entered into an agreement with theDutch-Belgian Cooperative Trial Group for Hematology Oncology (the"HOVON") to conduct a clinical trial of laromustine(Cloretazine(R) (VNP40101M)) with standard remission-inductiontherapy in patients aged 18-65 with previously untreated acutemyelogenous leukemia (AML) and high-risk myelodysplasia (MDS).
Alan Kessman, Chief Executive Officer, commented, "We arepleased to be working with HOVON, one of the most prestigiousclinical groups in hematology oncology. We continue to believe thatCloretazine(R) will have broad utility in the treatment ofhematological malignancies as both a single agent and incombination with other therapies. This trial will provide importantdata with regard to Cloretazine(R)'s utility in the treatment ofAML when given in combination with standard remission-inductiontherapy for this devastating disease."
Dr. Bob Lowenberg, Chief Investigator of HOVON, said, "HOVONis focusing on the clinical development of new therapeutic optionsfor patients with leukemia. Laromustine is a promising agent forthat effort."
The trial has been designed as a Phase III study in two parts. PartA will determine the feasibility (based on safety and preliminaryeffectiveness) of laromustine administration at three possible doselevels in combination with cytarabine and idarubicin. Part A willalso evaluate the pharmacokinetics and the clinical efficacy of thelaromustine combination.
Part B is then designed to evaluate the clinical efficacy of thelaromustine combination versus two cycles of cytarabine andidarubicin without laromustine with regard to clinical outcome("event free survival"), the complete remission rate,disease free survival (DFS), risk of relapse and overall survival(OS), as well as the tolerance and toxicity, and pharmacokineticsof the combination.
The trial is expected to start this fall and will be conducted atvarious sites in the Netherlands, Belgium, Switzerland and Norway.
About Vion
Vion Pharmaceuticals, Inc. is committed to extending the lives andimproving the quality of life of cancer patients worldwide bydeveloping and commercializing innovative cancer therapeutics. Vionhas two agents in clinical trials. Laromustine (Cloretazine(R)(VNP40101M)), a unique alkylating agent, is being evaluated in aPhase II pivotal trial as a single agent in elderly patients withpreviously untreated de novo poor-risk acute myelogenous leukemia.Clinical trials of Cloretazine(R) (VNP40101M) with cytarabine inelderly patients with acute myelogenous leukemia, with temozolomidein brain tumors, and with stem cell transplantation in advancedhematologic malignancies, are also being conducted. Triapine(R), apotent inhibitor of a key step in DNA synthesis, is being evaluatedin clinical trials sponsored by the National Cancer Institute. Foradditional information on Vion and its product developmentprograms, visit the Company's Internet web site at www.vionpharm.com .
About HOVON
HOVON is a Dutch-Belgian cooperative clinical trial group inhematology oncology with a strong clinical development program inleukemia, malignant lymphomas and multiple myeloma. The HOVON groupworks with several other countries in Europe and has along-standing track record with trials in acute leukemia. Adistinct part of its clinical trials concerns the analysis ofbiological variables of the disease in relation to treatmentoutcome.
This news release contains forward-looking statements. Suchstatements are subject to certain risk factors which may causeVion's plans to differ or results to vary from those expected,including Vion's potential inability to file a New Drug Applicationor obtain regulatory approval for its products, particularlyCloretazine(R) (VNP40101M), delayed or unfavorable results of drugtrials, the possibility that favorable results of earlierpreclinical studies, clinical trials or interim clinical trial dataare not predictive of safety and efficacy results in later or finalclinical trials, the need for additional research and testing, theinability to manufacture product, the potential inability to secureexternal sources of funding to continue operations, the inabilityto access capital and funding on favorable terms, continuedoperating losses and the inability to continue operations as aresult, the delisting of the Company's common stock from the NasdaqCapital Market and a variety of other risks set forth from time totime in Vion's filings with the Securities and Exchange Commission,including but not limited to the risks attendant to theforward-looking statements included under Item 1A, "RiskFactors" in Vion's Form 10-K for the year ended December 31,2007 and Form 10-Q for the quarter ended June 30, 2008. Inparticular, there can be no assurance as to the results of any ofthe Vion's clinical trials, that any of these trials will continueto full accrual, or that any of these trials will not bediscontinued, modified, delayed or ceased altogether. Except inspecial circumstances in which a duty to update arises under lawwhen prior disclosure becomes materially misleading in light ofsubsequent events, Vion does not intend to update any of theseforward-looking statements to reflect events or circumstances afterthe date hereof or to reflect the occurrence of unanticipatedevents.
COMPANY CONTACT: Vion Pharmaceuticals, Inc. Alan Kessman, ChiefExecutive Officer Howard B. Johnson, President & CFO (203)498-4210 phone Vion Pharmaceuticals, Inc.
CONTACT: Alan Kessman, Chief Executive Officer, or Howard B.Johnson,
President & CFO, both of Vion Pharmaceuticals, Inc.,+1-203-498-4210
Web site: http://www.vionpharm.com/