PharmAthene, Inc. Release: New Non-Clinical Data Demonstrate SparVax® Provides Equivalent Protection In Head-To-Head Comparison With BioThrax®
ANNAPOLIS, Md., Sept. 9, 2014 /PRNewswire/ -- PharmAthene, Inc. (NYSE MKT: PIP) announced today that recent non-clinical animal data from its SparVax® anthrax vaccine program were presented at the 54thInterscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington, DC.
In a poster presentation entitled, "Enhanced Next Generation rPA Vaccine Induces Immunogenicity and Efficacy at Least Equivalent to AVA in the New Zealand White (NZW) Rabbit Model for Anthrax," Dr. Sherry Crowe, Director, Immunology for PharmAthene, presented an overview of non clinical animal studies of SparVax® showing, among other things, that it can induce dose-dependent protective immunity in the established rabbit model for inhalational anthrax, and was statistically non-inferior to the currently licensed anthrax vaccine, BioThrax®, when comparing survival and toxin neutralization assay (TNA) results from the nonclinical anthrax aerosol challenge model.
In the latest anthrax challenge study, three groups of twenty NZW rabbits were vaccinated with SparVax® via intramuscular injection, on study days 0 and 28 at doses of 3, 9, or 27 micrograms. In addition, twenty animals were vaccinated with BioThrax®, the currently-licensed anthrax vaccine. On the 70th day of the study, the NZW rabbits were challenged with a lethal dose of aerosolized anthrax spores.
The study results demonstrated that SparVax® was statistically non-inferior compared to BioThrax® and provided equivalent protection against lethal aerosol anthrax challenge at the proposed human equivalent dose. In addition, the toxin neutralization (TNA) data showed that the neutralizing antibody titers for SparVax® were 1.5 to 2-fold higher than BioThrax® at all observed post-immunization time points, and statistically higher on the day before anthrax challenge.
Eric Richman, President and Chief Executive Officer, remarked, "One of the requirements for procurement of rPA vaccines is equivalency relative to the currently-licensed vaccine, so we are very pleased by these latest data for the SparVax® program. PharmAthene remains committed to advancing next generation medical countermeasures solutions that offer potential improvements in cost, efficacy and safety for our nation's citizens."
About PharmAthene
PharmAthene is a biodefense company engaged in the development and commercialization of next generation medical countermeasures against biological and chemical threats. PharmAthene's current biodefense portfolio includes the following product candidates:
- SparVax® - a next generation recombinant protective antigen (rPA) anthrax vaccine
- rBChE bioscavenger - a medical countermeasure for nerve agent poisoning by organophosphorous compounds, including nerve gases and pesticides
- Valortim® - a fully human monoclonal antibody for the prevention and treatment of anthrax infection
In addition, in August 2014, the Delaware Court of Chancery issued a Memorandum Opinion and Order and awarded to PharmAthene lump sum expectation damages for the value of PharmAthene's lost profits for SIGA Technologies, Inc.'s smallpox antiviral, Tecovirimat, also known as ST-246® (formerly referred to as "Arestvyr" and currently referred to by SIGA in its Current Report on Form 10-Q for the quarterly period ended June 30, 2014 as "Tecovirimat"). In addition, the Court ordered SIGA to pay prejudgment interest and varying percentages of PharmAthene's reasonable attorneys' and expert witness fees. A final order and judgment, specifying the damages amount and fees payable to PharmAthene is expected to be issued by the Court later this year.
Forward-Looking Statement Disclaimer
Except for the historical information presented herein, matters discussed may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Statements that are not historical facts, including statements preceded by, followed by, or that include the words "potential"; "believe"; "anticipate"; "intend"; "plan"; "expect"; "estimate"; "could"; "may"; "should"; "will"; "project"; "potential"; or similar statements are forward-looking statements. PharmAthene disclaims any intent or obligation to update these forward-looking statements other than as required by law. Risks and uncertainties include risks associated with our interest in Tecovirimat, also known as ST-246® (formerly referred to as "Arestvyr" and currently referred to by SIGA in its Current Report on Form 10-Q for the quarterly period ended June 30, 2014 as "Tecovirimat"); risks associated with the reliability of the results of the studies relating to human safety and possible adverse effects resulting from the administration of the Company's product candidates; unexpected funding delays and/or reductions or elimination of U.S. government funding for one or more of the Company's development programs, such as BARDA's recent decision to de-scope the current SparVax® anthrax vaccine contract through a partial termination for convenience; risks associated with the award of government contracts to our competitors; risks associated with unforeseen safety issues; risks associated with challenges related to the development, scale-up, technology transfer, and/or process validation of manufacturing processes for our product candidates; risks associated with unexpected determinations that these product candidates prove not to be effective and/or capable of being marketed as products; and other risks detailed from time to time in PharmAthene's Forms 10-K and 10-Q under the caption "Risk Factors" and in its other reports filed with the U.S. Securities and Exchange Commission. Further, significant additional non-clinical animal studies, human clinical trials, and manufacturing development work remain to be completed for all of our product candidates. In its August 2014 decision, the Delaware Court of Chancery awarded to PharmAthene lump sum expectation damages for the value of PharmAthene's lost profits for Tecovirimat, but the court did not specify an amount of damages, and such amount will be subject to argument between the parties. It remains subject to further appeal and as a result could be reversed, remanded or otherwise changed. There can be no assurances if and when PharmAthene will receive any payments from SIGA as a result of the decision. Furthermore, SIGA may not currently have cash sufficient to satisfy the potential award and PharmAthene cannot predict how or whether SIGA will be capable of making any payments provided for in a final judgment. Finally, the amount of the award remains subject to further calculation and approval by the court and there may be further proceedings before the final amount is approved by the Court, which will also remain subject to appeal. Copies of PharmAthene's public disclosure filings are available from its investor relations department and our website under the investor relations tab at www.PharmAthene.com.
SOURCE PharmAthene, Inc.