Profile: PharmAthene Inc (PIP.A)
11 Jul 2014
PharmAthene, Inc., incorporated on April 25, 2005, is a biodefense company engaged in the development and commercialization of medical countermeasures against biological and chemical threats. As of December 31, 2011, the Company’s biodefense portfolio of product candidates included SparVax, a second generation recombinant protective antigen (rPA) anthrax vaccine; Valortim, a fully human monoclonal antibody for the prevention and treatment of anthrax infection, and rBChE (recombinant butyrylcholinesterase) bioscavanger, a medical countermeasure for nerve agent poisoning by organophosphorous compounds, including nerve gases and pesticides.
SparVax: Recombinant Protective Antigen (PA)-based Anthrax Vaccine
SparVax is an rPA anthrax vaccine designed to protect against inhalational anthrax, the most lethal form of B. anthracis infection in humans. The vaccine has been shown to induce anti-Protective Antigen (PA) antibodies in clinical trials in healthy human volunteers and in animal models of inhalational anthrax. SparVax has been shown to generate in rabbits and non-human primates when vaccinated and subsequently exposed to lethal inhalation doses of anthrax spores. One Phase I and two Phase II clinical trials have been completed involving approximately 770 individuals. Data from these trials demonstrated that SparVax is generally well tolerated.
The Phase I trial was a dose escalation study designed to evaluate a range of dosage levels administered with either of two different dosing schedules. The Phase II program was designed to evaluate the safety and immunogenicity of the two highest dosages tested in Phase I using a three dose regimen in a larger number of subjects. In the Phase IIa trial, SparVax was highly immunogenic and generally well tolerated with no vaccine-related serious adverse events or changes in blood chemistries, vital signs or electrocardiogram (ECGs) reported.
Valortim: Anthrax Monoclonal Antibody
Valortim is a fully human monoclonal antibody designed to protect against and treat human inhalational anthrax, as both post-exposure prophylaxis and post-exposure therapy. Valortim functions by targeting PA, a protein component of the bacterium that attaches to and facilitates the entry of the destructive toxins Lethal Factor (LF) and Edema Factor (EF) into healthy cells in the infected person. Valortim is designed to bind to PA and protect the cells from damage by the anthrax toxins. In non-clinical studies, animals were protected against this fatal disease when Valortim was administered following a lethal aerosol challenge of anthrax spores, demonstrating that Valortim induces recovery and survival in animals exposed to inhalational anthrax. The Company is developing Valortim in collaboration with Bristol Myers Squibb, Inc. (BMS). Valortim is being developed for two indications: post-exposure prophylaxis, and as a therapeutic.
ST-246 is an orally administered anti-viral drug candidate being developed by SIGA Technologies, Inc. (SIGA), a third party, to treat orthopox virus diseases, including smallpox. In addition, ST-246 has been granted Orphan Drug designation for both the treatment and prevention of smallpox. ST-246 demonstrated 100% protection against human smallpox virus in a primate trial conducted at the Centers for Disease Control (CDC).
The Company competes with Emergent BioSolutions, Inc., BioThrax Anthrax Vaccine Adsorbed, Panacea Biotec Ltd, Cangene Corporation, Human Genome Sciences, Inc., Elusys Therapeutics, Inc., Emergent BioSolutions, Inc., IQ Corporation BV, Planet Biotechnology, Bayer AG, Ortho-McNeil Pharmaceuticals, Bavarian Nordic, Dynavax, Green Cross, PaxVax, Vaxin, and Pfenex.
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