ADVENTRX Pharmaceuticals Inc. Says FDA Seeks More Study on Cancer Drug

ADVENTRX Pharmaceuticals Inc. (ANX) Says FDA Seeks More Study on Cancer Drug
2/16/2011

SAN DIEGO, Feb. 15, 2011 /PRNewswire/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today provided an update on its product candidate, ANX-514, its polysorbate 80-free formulation of docetaxel. The U.S. Food and Drug Administration (FDA) determined that ANX-514 could not be approved based on the findings from the bioequivalence study of ANX-514 (Study 514-01) and that additional development activities would be required for approval. ADVENTRX met with the FDA to discuss required activities.

"We are pleased with the outcome of our discussion with FDA, at which the conceptual design of a single, additional clinical study that could support approval of ANX-514 was discussed. We believe the study requested by the Agency is reasonable, and we are developing a study protocol for submission to the FDA. We will provide a further update after receiving feedback from FDA on the protocol," said Brian M. Culley, Chief Executive Officer of ADVENTRX.

"We have netted over $50 million from financings during the last 18 months and we intend to use this capital to continue to develop ANX-514, to pursue acquisition opportunities, such as our recently-announced agreement to acquire SynthRx, and to prepare for the commercial launch of Exelbine, should it be approved," Mr. Culley continued.

ADVENTRX met with the FDA to discuss ANX-514. Prior to the meeting, ADVENTRX submitted to the FDA a data package based on Study 514-01 and published literature. ADVENTRX believes the data package supports the conclusion that comparable clinical outcomes can be expected following treatment with either ANX-514 or Taxotere®, despite Study 514-01 not demonstrating bioequivalence, its primary endpoint, using an unscaled bioequivalence methodology. In particular, the data package concludes that unbound docetaxel concentrations better represent the pharmacokinetics of docetaxel and are better predictors of clinical effects and outcomes.

The FDA did not agree that evaluating bioequivalence using unbound docetaxel concentrations was warranted and determined that data from Study 514-01 was not adequate to conclude that the short period of higher exposure to total docetaxel concentrations observed early in the treatment cycle with ANX-514 do not adversely affect the safety or efficacy of ANX-514 relative to Taxotere.

About ADVENTRX Pharmaceuticals

ADVENTRX Pharmaceuticals is a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary product candidates principally for the treatment of cancer. More information can be found on the Company's 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 are based on ADVENTRX's current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements regarding the potential for submission and approval of an ANX-514 NDA by the FDA based on a single, additional clinical study, the continued development of ANX-514 by ADVENTRX, including additional clinical and manufacturing work, and ADVENTRX's ability to fund such activities, ADVENTRX's belief that the short period of higher exposure to total docetaxel concentrations observed early in the treatment cycle with ANX-514 in Study 514-01 does not adversely affect the safety or efficacy of ANX-514 relative to Taxotere, the regulatory approval and commercial launch of Exelbine by ADVENTRX, and the potential for pipeline expansion through acquisition of new product candidates or technologies, including consummation of ADVENTRX's acquisition of SynthRx, Inc. Actual events or results may differ materially from those expressed or implied by the forward-looking statements in this press release due to a number of risks and uncertainties, including, without limitation: the potential for the FDA to require significant further nonclinical studies and/or clinical testing of ANX-514, including more than one clinical trial, which generally are more costly and lengthy than bioequivalence trials; the risk that additional nonclinical and/or clinical activities required by the FDA prior to the filing or the approval of a New Drug Application (NDA) for ANX-514 may result in ADVENTRX's determination that the commercial potential of ANX-514 does not justify the required investment and ADVENTRX's discontinuation of the program; the risk that, if ADVENTRX determines to continue development of ANX-514, ADVENTRX may need to raise additional capital to fund the additional development activities required by the FDA and that the necessity of such activities may negatively impact ADVENTRX's ability to raise additional capital for development of and/or partner ANX-514; difficulties or delays in manufacturing ANX-514 for additional clinical or bioequivalence studies; difficulties or delays in obtaining regulatory approval for ANX-514, even if ADVENTRX conducts additional nonclinical and/or clinical activities required by the FDA, including the potential for automatic injunctions regarding FDA approval of ANX-514 and other challenges by patent holders during the Section 505(b)(2) process; difficulties or delays in manufacturing and marketing ANX-514, including validating commercial manufacturing processes and manufacturers, as well as suppliers; ADVENTRX's reliance on the performance of third parties to assist in the conduct of its nonclinical, clinical and bioequivalence studies, regulatory submissions, CMC activities, commercial launch activities and other important aspects of the Exelbine and ANX-514 development programs, and that such third parties may fail to perform as expected; ADVENTRX's current dependence on the success of Exelbine and ANX-514 and the possibility that ADVENTRX does not receive regulatory approval of Exelbine or ANX-514 on a timely basis, or at all; the risk that ADVENTRX may not be able to successfully commercialize Exelbine or ANX-514 if it receives regulatory approval for those product candidates; the risk that ADVENTRX will pursue development activities at levels on timelines, or will incur unexpected expenses, that shorten the period through which its operating funds will sustain it; the potential that Exelbine and/or ANX-514 will be subject to a future collaboration or other strategic transaction; the risk that ADVENTRX's acquisition of SynthRx, Inc. may not be consummated; the potential for ADVENTRX to enter into a merger or other business combination in connection with a new product candidate acquisition resulting in a successor entity that focuses its resources on developing products and product candidates other than ADVENTRX's existing product candidates, including Exelbine and ANX-514; and other risks and uncertainties more fully described in ADVENTRX's press releases and periodic filings with the Securities and Exchange Commission. ADVENTRX's public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on 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 hereof, except as may be required by law.

SOURCE ADVENTRX Pharmaceuticals, Inc.

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ADVENTRX Pharmaceuticals Inc. Signs Definitive Agreement to Acquire SynthRx, Inc.

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SAN DIEGO, Feb. 14, 2011 /PRNewswire/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced that it has entered into a definitive agreement to acquire SynthRx, Inc. (SynthRx), a private biotechnology company developing a purified form of a rheologic and antithrombotic agent, poloxamer 188 (188).

"The acquisition of SynthRx will be a transformative event for ADVENTRX, adding another late-stage asset to our pipeline," stated Brian M. Culley, Chief Executive Officer of ADVENTRX. "The all-stock, milestone-based deal structure is a win for ADVENTRX and its stockholders in that it allows us to retain our cash for development activities and, other than a modest upfront equity payment, ensures we pay only as the 188 program achieves success. I'm pleased that we would have the data from the planned phase 3 study in-hand while having paid less than 25% of the total deal consideration."

"The 188 program will fit well with our existing assets and provide several exciting development opportunities. We would plan to meet with the FDA later this year to reach agreement on a protocol for a pivotal phase 3 study for the treatment of sickle cell crisis in a pediatric population, for which 188 has orphan drug designation. Sickle cell patients are an under-served population suffering from an excruciatingly painful condition with limited palliative options. Beyond sickle cell, we believe 188 has clinical benefits in other acute events related to microvascular-flow abnormalities, such as heart attack, stroke and hemorrhagic shock," Mr. Culley continued.

Under the terms of the all-stock transaction, SynthRx would become a wholly-owned subsidiary of ADVENTRX in exchange for shares of ADVENTRX common stock representing, in the aggregate, an approximately 4% ownership stake in ADVENTRX. SynthRx stakeholders also would be entitled to receive additional shares of common stock upon successful achievement of development milestones consisting of dosing the first patient in a phase 3 clinical study, acceptance by the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) and approval by the FDA of an NDA. If all milestones are achieved without reduction, the number of shares issued in connection with the acquisition would, in the aggregate, represent an approximately 40% ownership stake in ADVENTRX (based on currently outstanding shares plus shares issued in connection with the acquisition). Of the total number of shares issuable, more than 75% are based on NDA acceptance and approval.

If ADVENTRX's stockholders do not approve the issuance of the milestone-related shares as required by NYSE Amex listing standards, ADVENTRX expects to pay SynthRx's stakeholders in cash the value of the shares it otherwise would have issued, with the NDA acceptance and NDA approval milestone payments payable based on net sales of 188 and all milestone payments payable in quarterly installments.

About Poloxamer 188

Poloxamer 188 is a nonionic block copolymer surfactant that is believed to adhere to hydrophobic surfaces that develop when cells are damaged. It has been shown to restore hydration lattices and minimize the cascade of adhesive, inflammatory and coagulation responses that cause adhesion of cells, impaired blood flow and tissue ischemia. Improving blood flow in the microvasculature may benefit patients with sickle cell disease in acute crisis, which is associated with microvascular occlusion. Formulations of 188 have been extensively studied in numerous clinical trials, including a 2,950-patient, randomized, controlled study in acute myocardial infarction.

SynthRx's lead product candidate, a purified form of poloxamer 188, is an investigational product intended to treat micro-vascular disorders. Purified poloxamer 188 has been evaluated in multiple clinical studies, including a 255-patient, randomized, double-blind, placebo-controlled phase 3 study in patients with sickle cell disease in acute vaso-occlusive crisis. The FDA has granted orphan drug designation for poloxamer 188 for the treatment of sickle cell crisis.

About Sickle Cell Disease and Sickle Cell Crisis

Sickle cell disease (SCD) or sickle cell anemia (SCA) is a genetic, autosomal, recessive blood disorder characterized by red blood cells that assume an abnormal, rigid, sickle shape. This sickling is caused by an abnormality in the hemoglobin molecule found in red blood cells which carry oxygen throughout the body. Sickled red blood cells cannot pass through capillaries and may occlude capillaries and small blood vessels. This blockage can cause a wide range of serious and life-threatening conditions, including chronic hemolytic anemia, chronic pain and acute painful crisis, stroke, acute chest syndrome, as well as cumulative damage to tissues and organs.

Patients with SCD experience an average life expectancy of approximately 40 years. According to the National Institutes of Health (NIH) and the Sickle Cell Disease Association of America (SCDAA), it is estimated that over 70,000 people have sickle cell disease and about 1,000 babies are born with the disease each year in the United States.

Vaso-occlusive crisis is caused by sickle-shaped red blood cells that obstruct capillaries and restrict blood flow to an organ, resulting in ischemia (restriction of blood supply), pain, necrosis, and often organ damage. The frequency, severity, and duration of these crises can vary considerably.

Conference Call Information

ADVENTRX will hold a conference call today at 8:30 am ET to discuss the potential acquisition. Interested parties may access the conference call by dialing (800) 860-2442 from the U.S. and (412) 858-4600 from outside the U.S. and requesting the ADVENTRX Pharmaceuticals Corporate Update Call. The webcast will be available live via the Internet by accessing the Investors section of ADVENTRX's website at http://ir.adventrx.com. Replays of the webcast will be available on the Company's website for 30 days and a phone replay will be available through February 19, 2011 by dialing (877) 344-7529 from the U.S. and (412) 317-0088 from outside the U.S. and entering conference reference number 448547.

About ADVENTRX Pharmaceuticals

ADVENTRX Pharmaceuticals is a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary product candidates principally for the treatment of cancer. More information can be found on the Company's 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 are based on ADVENTRX's current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements regarding the form of consideration payable to SynthRx's stakeholders, development plans for 188, and 188's ability to demonstrate clinical benefits for patients suffering from sickle cell crisis and other microvascular-flow abnormalities. Actual events or results may differ materially from those expressed or implied by the forward-looking statements in this press release due to a number of risks and uncertainties, including, without limitation: the risk that ADVENTRX does not consummate its acquisition of SynthRx on a timely basis, or at all; the potential that ADVENTRX's stockholders do not approve the issuance of the milestone-related shares and ADVENTRX must pay the cash value of those shares, to the extent the milestones are achieved; the risk that ADVENTRX may not be able to integrate SynthRx's assets successfully into its operations or that it may incur unexpected costs and disruptions to its business as a result of such integration; the potential for the FDA to require ADVENTRX to perform additional nonclinical or clinical studies prior to initiating or following completion of the currently contemplated phase 3 clinical trial of 188 for the treatment of sickle cell crisis; the risk that subsequent nonclinical or clinical study results do not support the safety and efficacy or the commercial viability of 188 or any other product candidate developed using technology acquired from SynthRx; the risk that the neither the FDA nor any other regulatory agency approves a product based on 188 or any other product candidate developed using technology acquired from SynthRx on a timely basis, or at all; the potential for the out-of-pocket cost to ADVENTRX and the time required for development of 188 necessary to support an NDA submission are greater than ADVENTRX's current expectations; the risk that 188 loses its orphan drug designation for the treatment of sickle cell crisis or that a third party's product candidate is shown to be clinically superior and is approved by the FDA during 188's market exclusivity period; the risk that individuals previously involved in the development of 188 will not assist ADVENTRX in further development of 188 and that ADVENTRX may be unable to retain the services of other qualified individuals on a timely basis, or at all; ADVENTRX's planned reliance on third parties to assist with its nonclinical and clinical studies, regulatory submissions, manufacturing and other important aspects of the 188 development program, if it consummates its acquisition of SynthRx, and the risk that FDA approval may be delayed if their performance is found to be substandard; the potential that ADVENTRX may require substantial additional funding in order to obtain FDA approval for and commercialize 188, and the risk that ADVENTRX may not be able to raise sufficient capital when needed, or at all; and other risks and uncertainties more fully described in ADVENTRX's press releases and periodic filings with the Securities and Exchange Commission. ADVENTRX's public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on 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 hereof, except as may be required by law.

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