CM4 — Mechanisms of Action — Summary

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Effects on Tumor Necrosis Factor -α (TNF-α)

TNF-α is a highly inflammatory cytokine that predicts and/or profiles disease progression. In-Vitro work performed at Centers for Disease Control (CDC), Southern Research Institute (SRI), and Long Island Jewish Medical Center (LIJ) has demonstrated effective reduction of TNF-α with CM4. TNF-α elevation is linked to auto-immune diseases including: HIV/AIDS; Cancer; Crohn's Disease; Rheumatoid Arthritis.

"Insight" (Winter Issue, 1995), University of Alabama Birmingham (UAB) article — "New Smart Weapons Target Rheumatoid Arthritis" quoting: "UAB is involved in trials using a soluable TNF receptor that also blocks the action of TNF. Early results show reduced severity of arthritis."

In the same issue of "Insight" a separate article entitled, "A New Era of Therapy Emerges for Inflammatory Bowel Disease," further emphasizes the point — quoting: "TNF is a cytokine that appears to be one of the primary mediators of inflammation in Crohn's." These articles underscore the importance of this "mechanism of action" by CM4 in down regulating TNF.

Heat Shock Protein — A Major Immune Defense

CM4 demonstrated a marked increase in expression of heat shock proteins (hsp) 70-2, 70, 70-B, 40, and 90kd. Hsp transcription factor-4, c-fos, jun-B, and human activating transcription factor (AFT3) were also increased.

Radiation/Chemotherapy The hsp mechanism of action guards and protects the immune system from the harmful effects of radiation and chemotherapy. The patient's white blood cell count is reduced to dangerously low levels making them vulnerable to multiple pathogens. CM4 helps support the bone marrow output of white blood cells and thereby works to return low levels toward normal.

Anti-Viral

Studies conducted at the National Cancer Institute (NCI) demonstrated that CM4 contained moderate anti-viral activity. This result at NCI was consistent with patient improvements observed in clinical trials conducted under Investigational New Drug (IND) Application [i.e. clearing of leukoplakia (EB virus) and genital/perirectal warts (human papilloma virus)].

Supports the Immune System

In a series of experiments focused on determining the influence of CM4 on the immune system, Southern Research Institute, Birmingham, AL. demonstrated a mitogenic effect on both T- and B- cell populations. When CM4 was used in conjunction with non-mitogenic levels of Con-A, LPS, or low levels of stimulator cells in the mixed leukocyte culture (MLC) reaction, a significant stimulation of lymphocyte proliferation occurred, as suggested by increased thymidine uptake. Moreover, CM4, acting as a mitogen itself in the absence of additional co-factors, stimulated spleen cells in culture approximately 50-fold over background levels. These results depict some of the immune support functions of CM4.

Vaccine Adjuvant/Adjunct

Testing is proposed utilizing CM4 with sub-therapeutic doses of vaccines. The testing will have the following objectives: