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Adamis Therapeutics

The Company’s Adamis Therapeutics subsidiary is 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. For example, Adamis recently obtained exclusive world-wide rights to three new compounds for the treatment of prostate cancer (see press releases). In addition, Adamis acquired an exclusive license for a telomerase cancer vaccine that has already completed Phase 1 clinical testing in man. The vaccine was shown to be safe, induced an immune response in the vaccinated patients and the patient’s T cells were shown to kill prostate cancer cells. The telomerase vaccine could be called a “universal cancer vaccine” since telomerase is increased in over 85% of all cancers. Adamis is initially focusing on prostate cancer, but intends to move to other indications such as breast, lung and colon cancer. Since the same basic technology can be used to treat various cancer types, we believe this can truly be considered a “platform technology”.

In 2006 and 2007, two of the three compounds (APC-100 and APC-200) won the National Cancer Institute (NCI) Rapid Award. This award is given to drugs the NCI considers to be the most promising new drugs for the prevention and treatment of cancer. Adamis has strong patent claims and seeks to fill an unmet need in the multi-billion dollar prostate cancer market, where either there is no existing drug available or where current standard of care drugs are ineffective, often with intolerable side effects for the majority of patients. To date, over 18 million dollars of government funds have been awarded for the development of these three drugs.

Below is a brief summary of TeloB-Vax, APC-100, APC-200 and APC-300.


  1. TeloB-VAX: Prostate Cancer Telomerase Vaccine
    Adamis Pharmaceuticals is developing a novel cell-based therapeutic cancer vaccine, TeloB-VAX. TeloB-VAX utilizes the patient’s own B cells as antigen producing and antigen presenting cells. B cells represent approximately 12% of the circulating blood cells. Adamis’ product candidate is conceptually distinct from the only FDA approved cell-based cancer vaccine, Provenge. Although not definitively proven, Provenge is said to use the patient’s own dendritic cells.
  2. APC-100
    APC-100 is an orally administered compound that inhibits growth of cultured androgen-independent and dependent human prostate cancer cells, and has been shown to be an oxidative stress modulator drug that markedly reduces reactive oxygen species (ROS) in prostate cancer cells. In addition, APC-100 binds to the androgen receptor and acts as an androgen antagonist. Therefore, APC-100 exhibits a dual mechanism of action as both an inhibitor of the androgen signaling pathways as well as an anti-inflammatory oxidative stress modulator. In the TRAMP model of mouse prostate cancer, APC-100 is far superior to the marketed standard of care (90% efficacy vs. 55% efficacy). In mice, APC-100 increases time to tumor progression and increases survival. It has also been shown to decrease PSA production. An IND has been submitted to the FDA for Phase 1 studies in CRPC patients.
    1. In 2006, received a $4.5 million NCI Rapid Award as a first-in-class therapeutic oral drug for Castrate-Sensitive and Castrate-Resistant Prostate Cancer. The total funding received was approximately $8 million.
    2. Binds Androgen Receptor (AR) and is a potent anti-androgenic, anti-inflammatory and signal transduction inhibitor
    3. No effect on Androgen Receptor protein expression
    4. Increases Time to Tumor Progression (TTP) & increases Survival
    5. Tests in the TRAMP model of mouse prostate cancer show that APC-100 is far superior to the marketed standard of care (90% efficacy vs. 55% efficacy)
    6. Decreases Prostate Specific Antigen (PSA) production
    7. Versatile, safe and stable
    8. Bio-available: oral or injectable or implantable
    9. Low toxicity, no pro-Estrogenic feminizing side-effects
    10. High stability of stored API lots (active ingredients)
    11. Recurrent PCa (prostate cancer) patients more likely to be scripted, reimbursed, remain on non-toxic, orally available potent APC-100 therapeutic drug
    12. Broad world-wide IP including Japan: issued, pending & in progress
    13. U.S. IND was submitted in Feb. 2011
  3. APC-200
    In pre-clinical studies, APC-200 has demonstrated the ability to inhibit reactive oxygen species (ROS) formation specifically in prostate cancer cells and thereby blocks inflammation and androgen induced oxidative stress. Whereas acute inflammation is important for host defense, chronic inflammation contributes to tumor growth, progression to castrate resistant tumors and metastatic progression. In animal studies conducted to date, APC-200 was not only an excellent inhibitor of chronic inflammation, but also significantly delayed prostate cancer progression and increased survival in animal disease models. APC-200 is being developed as an orally administered drug and is in late-stage preclinical development.
    1. In 2007, received $5 million NCI Rapid Award as a first-in-class therapeutic oral drug for Castrate-Sensitive and Castrate-Resistant Prostate Cancer. Total funding has been approximately $7 million with $1.5 million still remaining to complete the IND data
    2. Irreversible inhibitor of the acetylpolyamine oxidase enzyme & effectively blocks inflammation and androgen induced oxidative stress; polyamine oxidation is a major path for ROS production in prostate and inhibition successfully delays PCa progression and increases survival
    3. Significantly delays PCa progression & death in TRAMP mice (prostate cancer model) with spontaneous prostate cancer
    4. Could be a good candidate for patients for whom Androgen Deprivation Therapy may not be approved or appropriate
    5. Versatile, safe and stable
    6. Bio-available: oral or injectable or implantable
    7. Low toxicity, no pro-Estrogenic feminizing side-effects
    8. High stability of stored API (active ingredients)
    9. IND-enabling data is over 90% complete; will be completed by mid 2011
    10. Straight-forward &cost-effective API manufacturing & formulation; manufacturing has begun
    11. Broad world-wide IP including Japan: pending & in progress
    12. U.S. IND to be submitted 4Q 2011- 1Q 2012
  4. APC-300
    APC-300 is a natural compound that, in pre-clinical studies, has been shown to not only inhibit the growth, but also stimulates the death of human prostate cancer cells. APC-300 is a small molecule signal transduction inhibitor that acts as an anti-inflammatory agent and blocks prostate cancer progression in in vivo models of the disease. In addition to prostate cancer, APC-300 has also demonstrated efficacy in disease models of human melanoma and pancreatic cancer. Adamis believes that APC-300 may have potential applications in the treatment of several tumor types. APC-300 is currently in preclinical development.
    1. Received $6.4 million in grant awards as a therapeutic oral drug for Castrate-Sensitive and Castrate-Resistant Prostate Cancer.
    2. Inhibits growth & kills both Castrate Sensitive- and Castrate Resistant –PCa
    3. Reduces prostate specific antigen (PSA) levels
    4. Decreases protein expression of Androgen Receptor
    5. Kills human PCa cells in vitro & in vivo
    6. Kills human prostate &other solid cancer cells, while sparing normal cells
    7. Induces Fas Receptor mediated-apoptotic signaling
    8. Is pro-apoptotic, inhibits multiple signaling targets and disrupts microtubule assembly
    9. In vitro significantly increased apoptotic death
    10. Versatile, safe and stable
    11. Bio-available: oral or injectable or implantable
    12. Low toxicity, no pro-Estrogenic feminizing side-effects
    13. High stability of stored API lots (active ingredients)
    14. Effective API manufacturing & formulation
    15. U.S. claims in prosecution (and relevent analogs) for broad world-wide IP (intellectual property) including Japan: in progress
    16. IND enabling tox data package needs to be collected