![](https://savarapharma.com/wp-content/uploads/page-header-blue-ridges-m.jpg)
![](https://savarapharma.com/wp-content/uploads/page-header-blue-ridges-d.jpg)
Filing
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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
TO SECTION 13 OR 15 (d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): December 7, 2005
ADVENTRX Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
(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)
San Diego, California 92121
(Address of principal executive offices) (Zip Code)
(858) 552-0866
(Companys telephone number, including area code)
(Companys telephone number, including area code)
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:
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 | ||||||||
EXHIBIT 99.1 |
Table of Contents
Item 8.01. Other Events.
On December 7, 2005, the Company announced that it had conducted a pre-IND meeting with the
US Food and Drug Administration regarding a proposed 505(b)(2) New Drug Application regulatory plan
for ANX-530 (vinorelbine emulsion) and that the FDA has affirmed the Companys proposal to conduct
a single bioequivalency study of ANX-530 as a marketing-enabling clinical trial.
The press release issued by the Company on December 7, 2005 with respect to this matter is
included with this report as an exhibit.
Item 9.01. Financial Statements and Exhibits.
(99)
|
(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. |
||||
By: | /s/ Carrie E. Carlander | |||
Name: | Carrie E. Carlander | |||
Title: | Chief Financial Officer, Vice President | |||
Finance, and Treasurer | ||||
December 7, 2005 |
Table of Contents
Exhibit 99.1
ADVENTRX ANNOUNCES POSITIVE FDA PRE-IND MEETING OUTCOME
ANX-530 Clinical Path Affirmed by FDA
SAN DIEGO December 07, 2005 ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) today announced that it
has conducted a pre-IND meeting with the US Food and Drug Administration (FDA) regarding the
proposed 505(b)(2) New Drug Application (NDA) regulatory plan for ANX-530 (vinorelbine emulsion).
The FDA has affirmed the Companys proposal to conduct a single bioequivalency study of ANX-530 as
a marketing-enabling clinical trial. ANX-530 is a novel, emulsion formulation of vinorelbine
tartrate. Vinorelbine is a chemotherapeutic agent indicated as a single agent or in combination
with cisplatin for treatment of advanced non-small cell lung cancer (NSCLC).
We are quite pleased that the FDA agreed with our clinical approach for ANX-530. Conducting a
single marketing-enabling trial gives us the most direct path toward launching ANX-530 as our first
commercial product, said Evan M. Levine, ADVENTRX president and CEO. We look forward to starting
this clinical trial by the first half of 2006 with the current objective of filing an NDA for
marketing approval in 2007.
The Company currently plans to file an investigational new drug (IND) application in the first half
of 2006. The proposed clinical trial will compare the bioequivalency of ANX-530 and vinorelbine in
patients with advanced solid tumors. In addition, the Company plans to collect comparative data on
vein irritation and other safety parameters as secondary endpoints. The Company holds certain
exclusive rights to ANX-530 per the licensing agreement with SD Pharmaceuticals, Inc. announced in
October 2005.
Section 505(b)(2) of the US Food, Drug & Cosmetic Act permits the FDA to approve a new drug
application (NDA) in part on the basis of published literature or on a previous finding of safety
or effectiveness of a drug. A 505(b)(2) application can apply to new chemical entities or to
changes to previously approved drugs. Examples of 505(b)(2) applications include changes to dosage
forms, routes of administration, or in the case of ANX-530, changes to the formulation. This
procedure potentially allows drug manufacturers to obtain more rapid approval of new forms of drugs
based in part by referencing proprietary data from the original drug manufacturer.
Vinorelbine inhibits cellular replication and ultimately causes cellular death by disrupting
microtubule formation. Vinorelbine and other drugs in the vinca alkaloid category are classified
as vesicants and may cause severe injection site reactions. Vinorelbine can cause both irritant
and vesicant types of injection site reactions. Irritants cause an acute and limited irritation to
the vein while vesicants cause an injection site reaction. Studies have shown injection site
reactions, including erythema, pain at injection site, and vein discoloration occur in
approximately one third of NSCLC patients treated with vinorelbine.
ANX-530 Pre-clinical Studies:
ANX-530 has demonstrated the ability to markedly reduce injection-site irritation in preclinical testing, compared to NavelbineÒ, GlaxoSmithKlines approved form of vinorelbine tartrate. NavelbineÒ prescribing information includes a black box warning for necrosis and thrombophlebitis. Pre-clinical studies with ANX-530 showed equivalent pharmacokinetic and pharmacodynamic profiles when compared to Navelbine. Vinorelbine tartrate is currently used as a monotherapy or in combination with other chemotherapeutic agents for the treatment of non-small cell lung, breast, ovarian and other cancers.
ANX-530 has demonstrated the ability to markedly reduce injection-site irritation in preclinical testing, compared to NavelbineÒ, GlaxoSmithKlines approved form of vinorelbine tartrate. NavelbineÒ prescribing information includes a black box warning for necrosis and thrombophlebitis. Pre-clinical studies with ANX-530 showed equivalent pharmacokinetic and pharmacodynamic profiles when compared to Navelbine. Vinorelbine tartrate is currently used as a monotherapy or in combination with other chemotherapeutic agents for the treatment of non-small cell lung, breast, ovarian and other cancers.
About Non-Small Cell Lung and Breast Cancers:
According to the American Cancer Society, approximately 80% of the more than 173,000 Americans
diagnosed with lung cancer each year have non-small cell lung cancer (NSCLC). Lung cancer is the
leading cause of cancer death and more than 160,000 people in the US will die each year from the
disease. Breast cancer is the most common non-skin cancer and second leading cause of
cancer-related death in women with more than 200,000 new cases diagnosed in the US annually.
About ADVENTRX
ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on introducing new technologies for anticancer and antiviral treatments that improve the performance and safety of existing drugs by addressing significant problems such as drug metabolism, toxicity, bioavailability and resistance. The Companys lead compound, CoFactor, is a biomodulator of 5-fluorouracil (5-FU), a widely used cancer chemotherapy. Phase II and Phase IIb clinical trials are ongoing to evaluate CoFactor use with 5-FU as a first line treatment of metastatic colorectal cancer. The Company has received clearance under a special protocol assessment from the US Food and Drug Administration (FDA) to begin a CoFactor Phase III pivotal clinical trial for metastatic colorectal cancer, which is currently planned to begin patient dosing in Q1 2006. More information can be found on the Companys Web site at www.adventrx.com.
ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on introducing new technologies for anticancer and antiviral treatments that improve the performance and safety of existing drugs by addressing significant problems such as drug metabolism, toxicity, bioavailability and resistance. The Companys lead compound, CoFactor, is a biomodulator of 5-fluorouracil (5-FU), a widely used cancer chemotherapy. Phase II and Phase IIb clinical trials are ongoing to evaluate CoFactor use with 5-FU as a first line treatment of metastatic colorectal cancer. The Company has received clearance under a special protocol assessment from the US Food and Drug Administration (FDA) to begin a CoFactor Phase III pivotal clinical trial for metastatic colorectal cancer, which is currently planned to begin patient dosing in Q1 2006. More information can be found on the Companys 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, regarding ADVENTRX. Such statements are made based on managements 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 regarding ADVENTRX, see the section titled Risk Factors in ADVENTRXs last quarterly report on Form 10-Q, as well as other reports that ADVENTRX files from time to time with the Securities and Exchange Commission. All forward-looking statements regarding ADVENTRX are qualified in their entirety by this cautionary statement. ADVENTRX undertakes no obligation to release publicly any revisions, which may be made to reflect events or circumstances after the date hereof.
This press release contains forward-looking statements, within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, regarding ADVENTRX. Such statements are made based on managements 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 regarding ADVENTRX, see the section titled Risk Factors in ADVENTRXs last quarterly report on Form 10-Q, as well as other reports that ADVENTRX files from time to time with the Securities and Exchange Commission. All forward-looking statements regarding ADVENTRX are qualified in their entirety by this cautionary statement. ADVENTRX 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
ADVENTRX Pharmaceuticals
Andrea Lynn
858-552-0866