-----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, Ver6zUaWWZYdj55L1r5ppKvc463ojkqf1ImfpXoxz7UN119HVayGIAyx+M5GimTm KpQE8XNbxTn9RsD7yeCswA== 0001144204-05-009083.txt : 20050330 0001144204-05-009083.hdr.sgml : 20050330 20050329213612 ACCESSION NUMBER: 0001144204-05-009083 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050329 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050330 DATE AS OF CHANGE: 20050329 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ADVENTRX PHARMACEUTICALS INC CENTRAL INDEX KEY: 0001160308 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 841318182 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-32157 FILM NUMBER: 05711347 BUSINESS ADDRESS: STREET 1: 6725 MESA RIDGE ROAD STREET 2: SUITE 100 CITY: SAN DIEGO STATE: CA ZIP: 92131 BUSINESS PHONE: 8585520866 MAIL ADDRESS: STREET 1: 6725 MESA RIDGE ROAD STREET 2: SUITE 100 CITY: SAN DIEGO STATE: CA ZIP: 92131 FORMER COMPANY: FORMER CONFORMED NAME: BIOKEYS PHARMACEUTICALS INC DATE OF NAME CHANGE: 20010928 8-K 1 v015202.htm Unassociated Document

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) March 29, 2005

ADVENTRX Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)

Delaware
(State or other jurisdiction of incorporation)


001-32157
(Commission File Number)
 
84-1318182
(IRS Employer Identification No.)


6725 Mesa Ridge Road, Suite 100
San Diego, California 92121
(Address of principal executive offices) (Zip Code)


(858) 552-0866
(Company’s telephone number, including area code)


 



Item 8.01. Other Events.

On March 29, 2005, the Company announced certain developments regarding its planned CoFactor Phase III trial for pancreatic cancer in the European Union.

The press release issued by the Company on March 29, 2005 with respect to these matters is included with this report as an exhibit.

Item 9.01. Financial Statements and Exhibits.
 
(c) The exhibit list required by this item is incorporated by reference to the Exhibit Index filed as part of this report.


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.
 
     
  ADVENTRX Pharmaceuticals, Inc.
 
 
 
 
 
 
Date: March 29, 2005 By:   /s/ Carrie E. Carlander
 
Name: Carrie E. Carlander
  Title: Chief Financial Officer, Vice President, Finance, and Treasurer


 




EXHIBIT INDEX

Exhibit
Description
99.1
 
Press Release of the Company dated March 29, 2005.
 


 


EX-99.1 2 ex-99_1.htm Unassociated Document

Exhibit 99.1

ADVENTRX RECEIVES COFACTOR PANCREATIC CANCER CLINICAL
DESIGN AND PROTOCOL FINAL ADVICE LETTER FROM EMEA

SAN DIEGO - March 29, 2005 - ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) today announced receipt of a final advice letter from the European Medicines Agency (EMEA) for its proposed CoFactor™ trial protocol in pancreatic cancer. Based on this information, the Company currently plans to file a Clinical Trial Application for a pivotal Phase III multinational study in patients with advanced pancreatic cancer in the second quarter of 2005 and will initiate the trial following regulatory clearance. CoFactor is a biomodulator designed to enhance the activity of the widely used cancer drug 5-fluorouracil (5-FU).

The final advice letter was received following a recent meeting between ADVENTRX and the EMEA in which the Company sought assistance on the trial design protocol. Protocol assistance with the EMEA was provided without additional cost to the Company under the Orphan drug act. CoFactor was granted orphan drug status for pancreatic cancer in both the European Union (EU) and US in October of last year.

The primary endpoint of the proposed pivotal Phase III clinical trial is time to tumor progression with secondary endpoints of objective response, quality of life and overall survival. Approximately 480 patients will be randomized to receive either CoFactor/5-FU/gemcitabine or gemcitabine alone. Gemcitabine is the current standard of care in the EU and US for advanced pancreatic cancer. The international trial is expected to be conducted at both EU and non-EU clinical sites.

In a previous Phase I/II clinical trial in Europe, CoFactor in combination with 5-FU demonstrated clinical benefit, defined as stable disease or tumor response, in 40% of pancreatic patients.

“Our progress with the EMEA marks an important milestone in our efforts to advance CoFactor through the clinical process,” said Cellia Habita, M.D., Ph.D., senior vice president of clinical and medical affairs for ADVENTRX. “Our earlier clinical studies with CoFactor in combination with 5-FU as a cancer therapy indicates its potential to lower toxicities and increase survival compared with current therapies. Pancreatic cancer is among the most fatal cancers with less than 5 percent of patients surviving more than five-years following diagnosis."

CoFactor in combination with 5-FU is currently being studied in a Phase II trial in metastatic colorectal cancer in the US and Europe. During the first quarter of 2005, ADVENTRX filed for clearance with the US Food and Drug Administration to launch a Phase III randomized, controlled trial in metastatic colorectal cancer. Also during the first quarter of 2005, the Company filed Clinical Trial Applications in the EU, including the United Kingdom and Germany, and in countries outside the EU, for clearance to evaluate CoFactor in a Phase IIb, international, multi-center, randomized, controlled trial for metastatic colorectal cancer.


About ADVENTRX
ADVENTRX Pharmaceuticals, Inc. is a biopharmaceutical research and development company focused on introducing new technologies for anticancer and antiviral treatments that improve the performance of existing drugs and address significant problems such as drug metabolism, bioavailability and resistance. More information can be found on the Company's Web site at www.adventrx.com.

Forward Looking Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such statements are made based on management's current expectations and beliefs. Actual results may vary from those currently anticipated based upon a number of factors, including uncertainties inherent in the drug development process, the timing and success of clinical trials, the validity of research results, and the receipt of necessary approvals from the FDA and other regulatory agencies. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see “Risk Factors” in the Company’s last quarterly report on Form 10-QSB, as well as other reports that the Company files from time to time with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by this cautionary statement. The Company undertakes no obligation to release publicly any revisions, which may be made to reflect events or circumstances after the date hereof.


Contact:
ADVENTRX Pharmaceuticals
Andrea Lynn
858-552-0866

Investor Contact:
Lippert Heilshorn & Associates
Jody Cain (jcain@lhai.com)
Brandi Floberg (bfloberg@lhai.com)
310-691-7100

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