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Adamis Pharmaceuticals Receives Notice Of Key Allowance For US Patent That Supports Its Cancer Immunology Portfolio


1/24/2014 9:03:52 AM

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SAN DIEGO, CA--(Marketwired - January 24, 2014) - Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) announced an important addition to its intellectual property with receipt of a Notice of Allowance of patent claims supporting its cancer immunotherapy portfolio in the United States. Notice of Allowance is the final step in the issuance of a patent. The company believes that this patent will significantly strengthen Adamis' cancer immunotherapy patent portfolio and will further support its TeloB-VAX vaccine technology. Claims to a patent entitled "Composition and Method for Inducing and Enhancing a Telomerase Reverse Transcriptase-Reactive Cytotoxic T Lymphocyte Response" have been allowed. These include claims for peptides that induce or enhance a cytotoxic T cell immune response against the human tumor antigen telomerase reverse transcriptase.

About TeloB-VAX

TeloB-Vax is an important asset in Adamis' oncology pipeline. The technology forming the basis for the patent was discovered and developed by Maurizio Zanetti, M.D., at the University of California, San Diego (UCSD). In 2011, Adamis licensed this technology from the Regents of the University of California as well as a complementary patent, "Cancer Immunotherapy and Diagnosis Using Universal Tumor Associated Antigens, Including Human Telomerase Reverse Transcriptase," from the Dana-Farber/ Harvard Cancer Center.

These technologies constitute the basis of a novel cell-based cancer vaccine product candidate, TeloB-VAX, which has been shown to activate the body's natural defense system to stimulate an immune response against one of cancer's most common tumor markers, telomerase. The vaccine utilizes the patient's own B cells as antigen producing and antigen presenting cells. The B cells present telomerase peptides to the T cells that then expand and search out and kill prostate cancer cells.

Dr. Zanetti has said of the TeloB-Vax vaccine technology, "It may represent one of the first concrete opportunities to program the immune system to induce killer lymphocytes to combat cancer cells, whether these are adult differentiated cells or progenitor cancer stem cells. Since telomerase is increased in over 85% of all cancers, the vaccine could potentially be used to treat multiple cancer types, such as breast, lung, and colon cancer. I believe that it can truly be considered a platform therapeutic vaccine technology." Telomerase was the subject of the Nobel Prize for Medicine in 2009.

Adamis' TeloB-VAX vaccine technology is composed of the patient's own circulating B lymphocytes harboring a unique patented engineered plasmid DNA. The transfection procedure is "spontaneous," requiring no facilitating molecules or devices. After 60 minutes of incubation with the plasmid, the patient's own cells can be re-infused.

In a Phase 1 study already completed at UCSD in castrate resistant prostate cancer patients, the vaccine product was shown to be safe, non-toxic and immunogenic. Two injections of TeloB-VAX, spaced one month apart, was shown to induce a specific CD8 T cell response. More important, the T cells were shown to specifically kill prostate cancer cells.

Dr. Dennis J. Carlo, President and CEO of Adamis Pharmaceuticals, stated, "At the J.P. Morgan Healthcare Conference last week, immunotherapy occupied much of the spotlight. We believe that our telomerase therapeutic cancer vaccine could prove to be important in the treatment of cancer. Harnessing and directing a systemic immune response that targets tumor cells throughout the body might be possible through the use of our vaccine technology. Telomerase is probably the closest to any universal tumor marker that we know of today."

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. The company's current specialty pharmaceutical product candidates include 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 vaccine product candidates and cancer drug product candidates under research and development include TeloB-VAX, a 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:

  • December 13 - Adamis commenced trading on Nasdaq.

  • December 18 - Adamis announced the closing of its underwritten public offering of common stock.

  • December 27 - Adamis announced the completion of the acquisition of Taper dry powder inhaler technology.

  • January 13 - Adamis announced full exercise of underwriter's over-allotment option in connection with the public offering of common stock.

Forward Looking Statements

This press release may contain forward-looking statements within the meaning of federal securities laws that relate to future events or our future results of operations, including, but not limited to the following statements: our ability to successfully develop the TeloB-VAX product candidate or any other product candidate; the safety, efficacy or therapeutic impact of any product candidate that we may develop; our ability to fund future product development and business operations; the intellectual property protection that may be afforded by any patents or patent applications relating to the company's technology; and the results of any future preclinical or clinical trials that may be conducted concerning TeloB-VAX or any other product candidate. Forward looking statements involve risks and uncertainties, and are not guarantees of future performance. Actual events or results may differ materially from those contemplated by such forward looking statement. Forward looking statements assume that we will have sufficient funding to support the activities contemplated by such forward looking statements and that there are no significant unexpected developments or events that delay or prevent such activities from occurring. There can be no assurance that this will be the case. You should not place undue reliance on any forward-looking statements. 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.


Adamis Contacts

Mark Flather
Director, Investor Relations &
Corporate Communications
Adamis Pharmaceuticals Corporation
(858) 412-7951
mflather@adamispharma.com

Mark Gundy
Capital Group Communications, Inc.
(972) 240-1873
mark.gundy@capitalgc.com



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