Filing
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): | June 30, 2010 |
ADVENTRX Pharmaceuticals, Inc.
__________________________________________
(Exact name of registrant as specified in its charter)
Delaware | 001-32157 | 84-1318182 |
_____________________ (State or other jurisdiction |
_____________ (Commission |
______________ (I.R.S. Employer |
of incorporation) | File Number) | Identification No.) |
6725 Mesa Ridge Road, Suite 100, San Diego, California | 92121 | |
_________________________________ (Address of principal executive offices) |
___________ (Zip Code) |
Registrants telephone number, including area code: | 858-552-0866 |
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:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01 Other Events.
On June 30, 2010, ADVENTRX Pharmaceuticals, Inc. issued a press release announcing the results of stability tests performed on samples of ANX-530 (vinorelbine injectable emulsion), or ExelbineTM, manufactured at ADVENTRX’s intended commercial manufacturing site. The 9-month stability data are on track to support the submission of a New Drug Application (NDA) for Exelbine. The press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
The list of exhibits called for by this Item is incorporated by reference to the Exhibit Index filed with 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. | ||||
June 30, 2010 | By: |
/s/ Patrick L. Keran
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Name: Patrick L. Keran | ||||
Title: Chief Operating Officer |
Exhibit Index
Exhibit No. | Description | |
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99.1
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Press release, dated June 30, 2010 |
ADVENTRX ANNOUNCES 9-MONTH STABILITY DATA RESULTS FOR ANX-530
SAN DIEGO (June 30, 2010) ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced the results of stability tests performed on samples of ANX-530 (vinorelbine injectable emulsion), or ExelbineTM, manufactured at the Companys intended commercial manufacturing site. The 9-month stability data are on track to support the submission of a New Drug Application (NDA) for Exelbine.
These results are consistent with our expectations and what we anticipate from the 12-month data, said Brian M. Culley, Chief Executive Officer of ADVENTRX. Once the 12-month data is analyzed, we will prepare and submit the Exelbine NDA, which we expect will take place in the fourth quarter of this year.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a specialty pharmaceutical company whose product candidates are
designed to improve the performance of existing cancer treatments by addressing limitations
associated principally with their safety and use. More information can be found on the Companys
web site at www.adventrx.com.
Forward Looking Statements
ADVENTRX cautions you that statements included in this press release that are not a description of
historical facts are forward-looking statements that involve risks and assumptions that, if they
materialize or do not prove to be accurate, could cause ADVENTRXs results to differ materially
from historical results or those expressed or implied by such forward-looking statements. These
risks and uncertainties include, but are not limited to: the risk that future stability testing
results are not consistent with prior results or are out-of-specification or otherwise do not
support comparability between ADVENTRXs prior and intended commercial manufacturing sites or a
commercially-viable expiration dating period; the risk that the FDA does not accept a submitted
Exelbine NDA for review, including as a result of identifying clinical or nonclinical reasons for a
refusal-to-file or identifying CMC reasons that were not identified in the refusal-to-file of the
previously submitted Exelbine NDA; ADVENTRXs dependence on the success of Exelbine, and
uncertainty as to whether Exelbine will receive regulatory approval or be commercialized
successfully; the risk that the bioequivalence data and other information included in the Exelbine
NDA may not adequately support bioequivalence with Navelbine®; the potential that changes made in
transferring the manufacturing process for Exelbine may result in a lack of comparability between
the commercial product and the material used in the bioequivalence trial, and that the FDA may
require ADVENTRX to perform additional nonclinical, bioequivalence or clinical studies; the
potential for the FDA to impose other requirements to be completed before or after approval of the
Exelbine NDA; the risk that ADVENTRX will pursue development activities at levels or on timelines,
or will incur unexpected expenses, that shortens the period through which its operating funds will
sustain it; and other risks and uncertainties more fully described in ADVENTRXs press releases and
periodic filings with the Securities and Exchange Commission. ADVENTRXs public filings with the
Securities and Exchange Commission are available at www.sec.gov.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date when made. ADVENTRX does not intend to revise or update any forward-looking statement set forth in this press release to reflect events or circumstances arising after the date on which it was made.
Company:
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Investor Relations: | |
ADVENTRX Pharmaceuticals Ioana C. Hone (ir@adventrx.com) 858-552-0866 |
Lippert/Heilshorn & Associates, Inc. Don Markley (dmarkley@lhai.com) 310-691-7100 |
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