ADVENTRX Announces Positive FDA Pre-IND Meeting Outcome
December 07 2005 - 10:00AM
PR Newswire (US)
ANX-530 Clinical Path Affirmed by FDA SAN DIEGO, Dec. 7
/PRNewswire-FirstCall/ -- 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 Company's 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
pre-clinical testing, compared to Navelbine(R), GlaxoSmithKline's
approved form of vinorelbine tartrate. Navelbine(R) 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 Company's lead
compound, CoFactor(TM), 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 Company's Web site at
http://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 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 regarding ADVENTRX, see the section
titled "Risk Factors" in ADVENTRX's 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. DATASOURCE:
ADVENTRX Pharmaceuticals, Inc. CONTACT: Andrea Lynn of ADVENTRX
Pharmaceuticals, Inc., +1-858-552-0866 Web site:
http://www.adventrx.com/ Company News On-Call:
http://www.prnewswire.com/comp/920134.html
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