-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, UCQROA5fIuVhhufVOVbBtZ1JZ1LmQ67wcPfRmhouFmDFCM6s1rZgCBKYbsqOVpRG jV/CNkTub2BKa9BCHm8nHA== 0000950123-09-002955.txt : 20090218 0000950123-09-002955.hdr.sgml : 20090218 20090217173935 ACCESSION NUMBER: 0000950123-09-002955 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20090217 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090218 DATE AS OF CHANGE: 20090217 FILER: COMPANY DATA: COMPANY CONFORMED NAME: VION PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000944522 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 133671221 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-26534 FILM NUMBER: 09616063 BUSINESS ADDRESS: STREET 1: 4 SCIENCE PARK CITY: NEW HAVEN STATE: CT ZIP: 06511 BUSINESS PHONE: 2034984210 MAIL ADDRESS: STREET 1: FOUR SCIENCE PARK CITY: NEW HAVEN STATE: CT ZIP: 06511 FORMER COMPANY: FORMER CONFORMED NAME: ONCORX INC DATE OF NAME CHANGE: 19950615 8-K 1 y01148e8vk.htm FORM 8-K 8-K
Table of Contents

 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
 
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
 
Date of Report (Date of earliest event reported) February 17, 2009
VION PHARMACEUTICALS, INC.
 
(Exact Name of Registrant as Specified in its Charter)
         
Delaware   000-26534   13-3671221
         
(State or Other Jurisdiction
of Incorporation)
  (Commission
File Number)
  (IRS Employer
Identification No.)
     
4 Science Park, New Haven, CT   06511
     
(Address of Principal Executive Offices)   (Zip Code)
Registrant’s telephone number, including area code: (203) 498-4210
Not Applicable
 
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
o     Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o     Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o     Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o     Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 


TABLE OF CONTENTS

Item 8.01 Other Events.
Item 9.01 Financial Statements and Exhibits.
SIGNATURES
EXHIBIT INDEX
EX-99.1: PRESS RELEASE


Table of Contents

Item 8.01 Other Events.
On February 17, 2009, Vion Pharmaceuticals, Inc. (the “Company”) announced that it has filed a New Drug Application (“NDA”) with the U.S. Food and Drug Administration for its lead oncology therapeutic OnriginÔ (laromustine) Injection as a single agent for remission induction treatment for patients sixty years of age or older with de novo poor-risk acute myeloid leukemia. The Company has requested a priority review for the application. A copy of the press release announcing the filing of the NDA is attached hereto as Exhibit 99.1 and incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
         
EXHIBIT NO.   DESCRIPTION
       
 
  99.1    
Press release dated February 17, 2009

 


Table of Contents

SIGNATURES
     Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
         
  VION PHARMACEUTICALS, INC.
 
 
Date: February 17, 2009  By:   /s/ Howard B. Johnson    
    Name:   Howard B. Johnson   
    Title:   President and Chief Financial Officer   

 


Table of Contents

         
EXHIBIT INDEX
         
EXHIBIT NO.   DESCRIPTION
  99.1    
Press release dated February 17, 2009

 

EX-99.1 2 y01148exv99w1.htm EX-99.1: PRESS RELEASE EX-99.1
(VION PHARMACEUTICALS, INC LOGO)
         
 
       
 
  COMPANY CONTACT:   Vion Pharmaceuticals, Inc.
 
      Alan Kessman, Chief Executive Officer
 
      Howard B. Johnson, President & CFO
 
      (203) 498-4210 phone
Vion Pharmaceuticals Submits New Drug Application for OnriginÔ
NEW HAVEN, CT, February 17, 2009 — VION PHARMACEUTICALS, INC. (OTC Bulletin Board: VION) announced today that it has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for its lead oncology therapeutic OnriginÔ(laromustine) Injection as a single agent for remission induction treatment for patients sixty years of age or older with de novo poor-risk acute myeloid leukemia (AML). The Company has requested a priority review for the application and, if granted, OnriginÔ could receive approval for this indication in the second half of 2009.
Alan Kessman, Chief Executive Officer, commented, “This NDA filing is a significant milestone for Vion and for the OnriginÔ clinical development program. Acute myeloid leukemia is a devastating disease, and patients and their physicians are seeking new treatment options that can provide the opportunity for achieving a complete response.” He concluded, “We are excited to be taking this major step towards achieving FDA approval for OnriginÔ.”
The OnriginÔ NDA submission is based on the results of an international multi-center pivotal Phase II trial of 85 patients sixty years of age or older with de novo poor-risk AML, supplemented by data from 55 patients in a previous Phase II trial in elderly AML. Eighty-six percent of these patients had two or more risk factors that predicted for a poor prognosis. The Company presented data on this group of patients in a poster at the American Society of Hematology (ASH) Annual Meeting in December 2008.
Dr. Frank Giles, Chief of the Division of Hematology and Medical Oncology and Deputy Director of the Cancer Therapy & Research Center at the University of Texas Health Science Center at San Antonio commented, “If approved, OnriginÔ would represent an important new treatment option for elderly AML patients, many of whom now have no effective therapeutic options. OnriginÔ‘s ability to generate meaningful complete responses after a single sixty- minute infusion makes its utility in this patient population particularly attractive.”
About OnriginÔ
OnriginÔ (laromustine) Injection, formerly known as Cloretazine® (VNP40101M), is a novel alkylating agent. OnriginÔ has been evaluated in over 800 patients in 16 clinical trials to date, including a pivotal Phase II trial in patients sixty years of age or older with de novo poor-risk AML. There are four clinical trials of OnriginÔ underway: (i) the continuation of the pivotal Phase II trial; (ii) a Phase III trial with

 


 

standard remission-induction therapy in patients with AML and myelodysplastic syndromes (MDS); (iii) a Phase I/II trial in combination with cytarabine in elderly patients with AML; and (iv) a Phase I/II trial in combination with temozolomide in patients with brain tumors.
About Acute Myeloid Leukemia (AML)
The American Cancer Society estimates that 13,290 new cases of AML were diagnosed in the U.S. in 2008. AML is primarily a disease of the elderly, with a median age at onset of 67 years. Compared to younger patients, older AML patients have a lower rate of response to currently available induction chemotherapy and shorter overall survival due, in part, to unfavorable prognostic factors such as a higher incidence of adverse cytogenetics and frequent co-morbidities. In addition, patients with risk factors such as advanced age and poor performance status tolerate current induction treatments poorly. A 2005 study by Lang et al, based on data from the National Cancer Institute’s Survey of Epidemiological and End Results (SEER) database, indicated that palliative care is given to the majority of elderly patients with AML in the U.S., providing additional evidence that new treatment options are needed for this population.
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, OnriginÔ and Triapine®. The Company has filed an NDA with the FDA for OnriginÔ for remission induction treatment for patients sixty years of age or older with de novo poor-risk AML. Triapine®, 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 OnriginÔ (laromustine) Injection (formerly CloretazineÒ (VNP40101M)), delays in the regulatory approval process, particularly for OnriginÔ (laromustine) Injection, including possible rejection by the FDA of our NDA filing, possible rejection by the FDA of our request for priority review, and possible delays in the FDA’ s review process beyond our expectation for approval in the second half of 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, 2007, Form 10-Q for the quarter ended September 30, 2008 and Amendment No. 1 to Form S-1 Registration Statement filed on February 2, 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.
# # #

 

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