Clinical Trial Of Immune-Assist ™ as an Adjunct for Chemo- and Radiation Therapy Wang Ruwei MD, PhD1 Xu Yiyuan MD, PhD1 Ji Peijun2 Wang Xingli3 John C. Holliday4 1. People’s Hospital in Lishui City, Zhejiang Province, PRC 2. Zhejiang Qingyuan Fungi Medicinal & Health Products Co., Ltd 3. Qingyuan Oriental Medicinal Mushroom Development Center 4. Aloha Medicinals Inc, Carson City, Nevada USA ABSTRACT: This trial was designed to assess the efficacy of Immune Assist™ dietary supplement as an adjunct therapy for improving the immune function and reduce the side effects of conventional therapies. Immune Assist™ is a dietary supplement ingredient manufactured in the United States of America by Aloha Medicinals Inc. of Carson City, Nevada USA, and marketed worldwide as a raw material and included in many proprietary formulas. Immune Assist™ is an orally active, immune-modulating beta-glucan/heteropolysaccharide formulation, derived from six species of fungi regularly used in Traditional Chinese Medicine (TCM) for patients undergoing cancer therapy using conventional treatments. The Immune Assist™ formulation is a complex blend of immune-active polysaccharides of several categories. This includes high molecular weight (HMW) non-linear Heteropolysaccharides, which tend to be insoluble or only slightly soluble in water, as well as a significant percentage (>39%) of 1,3-1,6 beta glucans with a triple right hand helix tertiary conformation, which is the form shown in nearly all previous research to be most active in triggering mammalian immune response. These 1,3-1,6 beta-glucans have a range of molecular weight from less than 20 kD to over 2,000 kD, and are thought to be effective in activating a wide range of immune responses. A tremendous body of reference work exists indicating over 800 different species of higher basidiomyces fungi (mushrooms) contain immune modulating and anti-tumor polysaccharide compounds with this tertiary structure. This has lead to the development of a number of drugs of the Lentinan class. These drugs are widely used (primarily in Asia) as adjuncts in the treatment of cancer. Prior to the introduction of the Immune Assist™ formula, all the mushroom-derived polysaccharide immune modulators brought to market have been derived from a single species of fungi, consisting of only a single molecular weight polysaccharide with single tertiary structure, which indicates the probable attachment to only single immune triggering receptors at the cellular level. However, recent advances in immune science have revealed a wide range of different cellular receptors, each of which attach to different structural types and sizes of polysaccharide molecules. This multireceptor, multi-structure binding indicates multiple mechanism of action in the triggering of immune responses, which is much more complex than was previously thought. While it has been known since the 1970’s that Natural Killer (NK) cells were activated by polysaccharide triggers, it is now believed that most, if not all, of the different classes of immune cells are activated or triggered by the attachment of either pure polysaccharides or protein-bound polysaccharide molecules to receptors found at the cell surface such as CR3, LacCer, Dectin-1 and other activation receptors. It is this multi-receptor activation pathway that lead to the development of Immune Assist™, which contains over 200 different immune-active polysaccharide structures. This complex polysaccharide formulation is thought to activate the full range of immune response in the human body.