New book by Larry Connors Click here Improve your trading - See how
Ann Cahill, Vice President, Clinical Development, commented, "This poster presents an objective analysis of the co-morbid conditions with which so many elderly AML patients present. It demonstrates that the patient population forming the basis of the efficacy claims in Vion's New Drug Application was indeed a poor-risk population, with multiple risk factors predicting for a poor prognosis."
In the analysis, 140 AML patients over the age of sixty treated with Onrigin in two Phase II clinical trials were analyzed for co-morbidity according to the hematopoetic cell transplantation-specific co-morbidity index (HCT-CI). The HCT-CI is an adapted version of the Charlson Comorbidity Index (CCI), and was originally developed to predict outcomes in patients undergoing allogeneic stem cell transplant. It has since been used to describe outcome for AML patients receiving induction chemotherapy. HCT-CI scores have been shown to be predictive of early death and survival in patients over the age of 60 receiving induction therapy for AML.
The 140 patients included all 85 patients from the Company's pivotal trial in elderly poor-risk AML, and 55 patients in a retrospectively determined subset from a previous trial in elderly AML. The median age of this population was 74 years. HCT-CI scores were separated into three risk groups for non-relapse mortality and survival: low (0), intermediate (1-2), and high (3 or greater). The analysis established that 81% of the patients in the combined population had an HCT-CI score of 3 or greater and that the median score was 5 (range 0-12), confirming the poor-risk nature of this patient group. Patients with an HCT-CI score of 3 or greater had an overall response rate of 34%, an induction death rate (death within 30 days of first induction) of 14%, and a Kaplan-Meier estimate of survival at twelve months of 21%.
About Vion
Vion Pharmaceuticals, Inc. is committed to extending the lives and improving the quality of life of cancer patients worldwide by developing and commercializing innovative oncology therapeutics. Vion has two agents in clinical trials, Onrigin (laromustine) Injection and Triapine(R). The Company has an NDA under review with the FDA for Onrigin for remission induction treatment for patients sixty years of age or older with de novo poor-risk acute myeloid leukemia (AML). Triapine(R), a potent inhibitor of a key step in DNA synthesis, is being evaluated in clinical trials sponsored by the National Cancer Institute. For additional information on Vion and its product development programs, visit the Company's Internet web site at www.vionpharm.com.
This news release contains forward-looking statements. Such statements are subject to certain risk factors which may cause Vion's plans to differ or results to vary from those expected, including Vion's potential inability to obtain regulatory approval for its products, particularly Onrigin (laromustine) Injection, delays in the regulatory approval process, particularly for Onrigin (laromustine) Injection, including possible delays in the FDA's review process beyond our expectation for approval in December 2009, delays or unfavorable results of drug trials, the possibility that favorable results of earlier preclinical studies, clinical trials or interim clinical trial data are not confirmed by safety and efficacy results in later or final clinical trials, the need for additional research and testing, the inability to manufacture product, the potential inability to secure external sources of funding to continue operations, the inability to access capital and funding on favorable terms, continued operating losses and the inability to continue operations as a result, and a variety of other risks set forth from time to time in Vion's filings with the Securities and Exchange Commission, including but not limited to the risks attendant to the forward-looking statements included under Item 1A, "Risk Factors" in Vion's Form 10-K for the year ended December 31, 2008, Vion's Form 10-Q for the quarter ended March 31, 2009, and Vion's Post-Effective Amendments on Form S-1 Registration Statement filed on March 23, 2009. Except in special circumstances in which a duty to update arises under law when prior disclosure becomes materially misleading in light of subsequent events, Vion does not intend to update any of these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
COMPANY CONTACT: Vion Pharmaceuticals, Inc.
Alan Kessman, Chief Executive Officer
Howard B. Johnson, President & CFO
(203) 498-4210
SOURCE Vion Pharmaceuticals, Inc.
http://www.vionpharm.com
More News:
Market Updates |
Stock Alerts |
All Trading News |
Stock Index
About TradingMarkets | Contact | Advertise | Careers | Link to Us | Site Map | Help | Terms & Conditions | Privacy Policy | Return Policy | Testimonials | Feedback
The Connors Group, Inc. ("Company") is not an investment advisory service, nor a registered investment advisor or broker-dealer and does not purport to tell or suggest which securities or currencies customers should buy or sell for themselves. The analysts and employees or affiliates of Company may hold positions in the stocks, currencies or industries discussed here. You understand and acknowledge that there is a very high degree of risk involved in trading securities and/or currencies. The Company, the authors, the publisher, and all affiliates of Company assume no responsibility or liability for your trading and investment results. Factual statements on the Company's website, or in its publications, are made as of the date stated and are subject to change without notice.
It should not be assumed that the methods, techniques, or indicators presented in these products will be profitable or that they will not result in losses. Past results of any individual trader or trading system published by Company are not indicative of future returns by that trader or system, and are not indicative of future returns which be realized by you. In addition, the indicators, strategies, columns, articles and all other features of Company's products (collectively, the "Information") are provided for informational and educational purposes only and should not be construed as investment advice. Examples presented on Company's website are for educational purposes only. Such set-ups are not solicitations of any order to buy or sell. Accordingly, you should not rely solely on the Information in making any investment. Rather, you should use the Information only as a starting point for doing additional independent research in order to allow you to form your own opinion regarding investments. You should always check with your licensed financial advisor and tax advisor to determine the suitability of any investment.
HYPOTHETICAL OR SIMULATED PERFORMANCE RESULTS HAVE CERTAIN INHERENT LIMITATIONS. UNLIKE AN ACTUAL PERFORMANCE RECORD, SIMULATED RESULTS DO NOT REPRESENT ACTUAL TRADING AND MAY NOT BE IMPACTED BY BROKERAGE AND OTHER SLIPPAGE FEES. ALSO, SINCE THE TRADES HAVE NOT ACTUALLY BEEN EXECUTED, THE RESULTS MAY HAVE UNDER- OR OVER-COMPENSATED FOR THE IMPACT, IF ANY, OF CERTAIN MARKET FACTORS, SUCH AS LACK OF LIQUIDITY. SIMULATED TRADING PROGRAMS IN GENERAL ARE ALSO SUBJECT TO THE FACT THAT THEY ARE DESIGNED WITH THE BENEFIT OF HINDSIGHT. NO REPRESENTATION IS BEING MADE THAT ANY ACCOUNT WILL OR IS LIKELY TO ACHIEVE PROFITS OR LOSSES SIMILAR TO THOSE SHOWN.
The Connors Group, Inc.
10 Exchange Place, Suite 1800
Jersey City, NJ 07302
© Copyright 2009 The Connors Group, Inc.