Home |
Contact Us |
Glossary |
Site Map |
|
|
||||||||
|
|
 |
|
 |
|
 |
|
 |
|
|
|
ABOUT VION |
|
PRODUCTS & PIPELINE |
|
CLINICAL TRIALS |
|
INVESTOR RELATIONS |
|
|
|
 WHAT'S NEW
|
|
ON DECEMBER 17, 2009 VION PHARMACEUTICALS, INC. VOLUNTARILY FILED FOR CHAPTER 11 BANKRUPTCY. PLEASE REFER TO THE PRESS RELEASE OR GO TO DELCLAIMS.COM FOR MORE INFORMATION. Vion's management believes that there will be no value for the common stockholders in Vion's bankruptcy liquidation process, even under the most optimistic of scenarios. Stockholders of a company in Chapter 11 generally receive value only if all claims of the company's creditors are fully satisfied. In this case, Vion's management believes all such claims will not be fully satisfied, leading to its conclusion that Vion common stock will have no value. Vion Pharmaceuticals, Inc. is developing novel agents for the treatment of cancer. We have two small molecule anticancer compounds under evaluation in human clinical trials. In February 2009, we submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for our potential product, Onrigin™ (laromustine) Injection, formerly Cloretazine® (VNP40101M), for remission induction treatment of acute myeloid leukemia (AML) in elderly de novo poor-risk patients. In September 2009 the Oncologic Drugs Advisory Committee (ODAC), which is the cancer drug advisory panel of the U.S. Food and Drug Administration (FDA), voted in favor of Vion completing a randomized study defining the efficacy and safety of the Company’s lead oncology therapeutic Onrigin™ (laromustine) Injection prior to receiving regulatory approval from the FDA. Vion had presented data for Onrigin™ for remission induction treatment for patients sixty years of age or older with de novo poor-risk acute myeloid leukemia (AML). In December 2009, we received a complete response letter from the FDA. The letter indicates that the FDA cannot approve the Company's NDA in its present form and provides recommendations to address the remaining issues. The complete response letter advised that the Company complete a randomized study or studies to define the efficacy and safety of Onrigin™ in the patient population proposed for the indication, and that the study or studies should be designed to demonstrate a survival benefit that is clearly attributable to Onrigin™ with an acceptable safety profile in a well-characterized patient population. In addition to clinical and statistical recommendations, the letter also addressed clinical pharmacology and manufacturing issues. The complete response letter also requested that the Company provide an update on Onrigin™ safety information when the issues above had been addressed. Clinical trials of Onrigin™ are underway in: (i) AML and myelodysplastic syndrome (MDS) in combination with cytarabine; (ii) AML and MDS in combination with standard remission-induction therapy; (iii) AML with unfavorable cytogenetics in combination with standard remission-induction chemothrapy; and (iv) brain tumors in combination with temozolomide. Our second potential product, Triapine®, is being evaluated in trials sponsored by the National Cancer Institute. 
|
|
|
|
|
||||
| Privacy | Terms of Use | Copyright | ©2009 Vion Pharmaceuticals, Inc.
|
|