SOURCE: Adamis Pharmaceuticals Corporation

September 09, 2013 09:30 ET

Adamis Announces Positive Results of Study Concerning C31G in Treating Herpes Simplex Virus (HSV) Eye Infection

SAN DIEGO, CA--(Marketwired - Sep 9, 2013) - Adamis Pharmaceuticals Corporation (OTCQB: ADMP) today announced that a recently published study conducted by university researchers found that the company's antimicrobial and spermicidal agent, C31G, was effective in treating Herpes Simplex Virus (HSV) in an eye infection (ocular keratitis) animal model. Adamis previously reported that C31G successfully completed a Phase 3 contraceptive clinical trial in humans conducted by the National Institute of Child Health and Human Development.

Dr. James M. Hill from Louisiana State University Health Science Center and several other investigators demonstrated that in their study C31G was effective in treating HSV in an animal model of eye infection using live rabbits. The rabbit eye model utilized for the study mimics the disease in humans. In the same study the researchers also reported that ocular administration of C31G was safe and well tolerated, confirming earlier clinical studies that established C31G safety and tolerability in other applications. The study titled "The antimicrobial agent C31G is effective for therapy for HSV-1 ocular keratitis in the rabbit eye model" appears in the latest issue of the scientific journal Antiviral Research.

HSV-1 is the same virus that causes cold sores and is very common in humans. It is estimated that as much as one-third of the world population suffers from various forms of recurring HSV infections. In the eye, it usually causes an infection of the cornea and that infection is the most common cause of cornea-derived blindness. Recent studies suggest that global incidence (rate of new disease) of HSV keratitis is approximately 1.5 million new cases per year including 40,000 cases of severe vision impairment or blindness. As previous animal studies have shown, C31G is also active against HSV-2, the cause of genital herpes.

Adamis owns intellectual property relating to an antimicrobial and contraceptive product candidate called C31G. C31G is an effective spermicide and broad-spectrum antibacterial agent, which in previous studies has shown activity against both gram-positive and gram-negative organisms, including chlamydia, and a range of antibiotic resistant strains. In considering commercialization alternatives, the company intends to seek opportunities to partner the commercialization of, or license the rights to develop and commercialize, C31G with third parties that have a focus in the areas of antimicrobials or contraception.

About Adamis Pharmaceuticals Corporation

Adamis Pharmaceuticals Corporation is a biopharmaceutical company engaged in the development and commercialization of specialty pharmaceutical and biotechnology products in the therapeutic areas of respiratory disease, allergy, oncology and immunology. In addition to the C31G technology, Adamis currently has four product candidates in its specialty pharmaceutical product pipeline, including the Epinephrine Injection PFS syringe product for use in the emergency treatment of anaphylaxis, APC-1000 and APC-5000 for the treatment of asthma and chronic obstructive pulmonary disease, and APC-3000, an HFA inhaled nasal steroid product for the treatment of allergic rhinitis. The Company's biotechnology efforts are focused on the development of therapeutic vaccine product candidates and cancer drugs for patients with unmet medical needs in the multi-billion dollar global cancer markets. Its products under research and development include TeloB-VAX, a novel cell-based therapeutic cancer vaccine and three drugs, APC-100, APC-200, and APC-300, for the treatment of prostate cancer.

Recent, previously-reported developments include the following:

  • July 1 - Adamis announced the completion of a private placement with gross proceeds of $5.3 million.

  • August 6 - Adamis announced the exclusive license of a dry powder inhaler technology.

  • August 21 - Adamis announced that it had received an allowance in the United States for a patent application relating to one of its prostate cancer compounds

Forward Looking Statements

This press release may contain forward-looking statements that relate to future events or our future results of operations or future financial performance, including, but not limited to the following statements: the ability to fund future product development and business operations; future revenues expected from any of the company's product candidates, assuming that they are developed and approved for marketing by the FDA and other regulatory authorities; our ability to complete any future acquisitions of products, product candidates or technologies; the intellectual property protection that may be afforded by any patents or patent applications relating to the company's technology; the results of any future preclinical or clinical trials that may be conducted concerning the use of C31G for the Herpes Simplex Virus or any other indication; and the interest of any third party in entering into an arrangement with the Company concerning the development, license, commercialization, or other arrangements or agreements concerning C31G. In addition, provisions in certain agreements to which the Company is a party provide for significant payments to certain third parties upon marketing approval by the FDA (or, in certain circumstances, certain foreign regulatory authorities) of C31G for one or more indications, and payments to other third parties in the event of sales or other revenues relating to C31G or certain other events. There can be no assurances that we will be able to successfully conclude a transaction involving C31G or concerning the amounts that we might receive from any such transaction, or that any C31G product will be submitted for regulatory approval or will be approved or marketed. Certain of these risks, uncertainties, and other factors are described in greater detail in Adamis' filings from time to time with the SEC, which Adamis strongly urges you to read and consider, all of which are available free of charge on the SEC's web site at http://www.sec.gov. Except as required by law, Adamis expressly disclaims any obligation to update any forward-looking statements.

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