EMBARGOED UNTIL THURSDAY, SEPTEMBER 22, 2011 11:30 AM, ET Contact: Michael Darden Publicity 917-868-8780 mdarden@perfectpitch-media.com Research on D-fraction Suggests Adjuvant Treatment Breakthroughs for Some Cancers D-fraction Combined with Conventional Chemotherapy Cuts Human Prostate-Carcinoma Cell Growth to a Greater Degree Than Chemo Alone (90 v. 50 Percent) D-fraction/Chemotherapy Combination Treatments Also a “Safe,” Possible Weapon against Colon, Stomach and Additional Carcinomas, and D-fraction Alone Ignites Breast-Cancer Cell "Suicide" East Rutherford, NJ-Researchers today announced several important findings concerning D-fraction, a unique extract from Maitake mushrooms, which may indicate adjuvant (complementary) treatment breakthroughs for some cancers (www.dfractionresearch.com). At Mushroom Wisdom's "D-fraction" press conference during Natural Products Expo East in Baltimore, Maryland, the researchers outlined results of their investigations of D-fraction on human cells via in vitro study. D-fraction combined with conventional chemotherapy agents significantly reduced prostate- and coloncarcinoma cell growth compared to treatment with the chemo agents alone. The combined D-fraction/chemotherapy treatment shrunk prostate carcinoma cell growth by 90 percent (v. 50 percent chemo alone) and reduced colon cancer growth by 60 percent (v. 33 percent chemo alone), according to New York Medical College's Sensuke Konno, PhD, whose related article has been accepted for publication in the American Academy of Anti-Aging Medicine's A4M NEWS.* What’s more, D-fraction sparks breastcancer cell apoptosis ("suicide"), suggests Centro Científico Tecnológico-Argentina's Gabriela Balogh, PhD, who along with other researchers authored an associated study published in the June 2011 JOURNAL OF MEDICINAL FOODS.** These and additional 1 findings concerning D-fraction's powerful assault as well on stomach and other cancers offer good news for patients and their loved ones, as Prostate Cancer Awareness is observed in September 2011, and Breast-, Stomach- and Colon-Carcinoma Awareness are separately observed in October and November 2011 and March 2012. Recently, it was estimated that in 2010 cancer would claim over a half-million lives in the United States. More investigation of these early, hopeful findings is warranted, the researchers say. Potential, New Adjuvant or Primary Therapy on Cancer “The current studies headed by Drs. Konno and Balogh further establish the breakthrough potential of D-fraction in the fight against cancer, both as an important adjuvant therapy and as a primary therapy,” says Mushroom Wisdom, Inc., President and Chief Executive Officer, Masaki ("Mike") Shirota. “This research follows numerous in vivo and clinical studies conducted in Japan and the U.S. at leading cancer research centers, including Memorial Sloan Kettering Cancer Center and Cancer Treatment Centers of America. Mushroom Wisdom has also received IND (Investigational New Drug) approval from the FDA for Maitake D-Fraction® Professional Strength (tincture) for Phase II clinical studies on advanced breast and prostate cancer patients.” D-fraction has been shown to increase numbers of immune cells and activity of those cells (i.e., it helps "more immune cells do more of what they are supposed to be doing"--protect the body against disease). Several (laboratory and clinical) studies show that the extract inhibits the growth of cancer cells by activating immune system cells or inducing the apoptosis (suicide) of cancer cells. D-fraction is a specific, proprietary, Maitake mushroom extract that has been found to have pronounced, immune-system-supporting benefits. This extraction yields a unique, protein-composed, active beta-glucan, whose distinctive size, shape, and chemistry make for greater activity and bioavailability in the human body and immune system. Another distinguishing factor is the water solubility of D-fraction that, unlike insoluble yeast betaglucans, may improve absorption when taken orally. It is important to remember that not all beta-glucans are created equal: Their individual characteristics and chemistry will, in the end, determine whether or not they are bioavailable and what kinds of actions, if any, they will have in the body. Despite structural similarities in the polysaccharides or glucans of various mushrooms or yeast, their efficacy may vary with specific disease states and other 2 disorders. D-fraction is commercially available in Mushroom Wisdom’s Maitake DFraction® Professional and Standard strength formulas. "Nothing else operates like this," says Mr. Shirota. Dr. Konno's Cancer-Treatment Research Results Dr. Sensuke Konno investigated if D-fraction (DF) at 300 µg/ml dose might work cooperatively with certain anti-cancer, chemotherapeutic drugs in several cancer types. Among other experiments, a dose-dependent study (with varying concentrations of drugs) was performed using the first-priority drug for each human, cancer cell line--prostate, breast, colon, stomach and lung, 100 cells each--combined with DF for 72 hours: Prostate The drug Carmustine (50 µM dose) combined with D-fraction resulted in 90 percent PC-3 prostate-cancer cell death, compared with 50 percent growth reduction by the drug alone, in addition to other results. Breast Among other findings, the drug Paclitaxel (30 nM dose) has a significant anti-proliferative activity but the DF-Paclitaxel combination does not appear to further improve the drug's anti-proliferative activity--the D-fraction-Paclitaxel combination, compared with the drug alone, produced no more than a 10 percent (77 v. 67) increase in MDA-MB231 breastcancer cell-growth reduction. Colon The combination of the drug 5-Fluorouracil (300 ng/ml dose) and D-fraction resulted in 60 percent growth reduction in Caco-2 colon-cancer cells (the drug alone led to 33-percent growth decrease), in addition to other results. Stomach Among other findings, the combination of the drug 5-Fluorouracil (300 ng/ml dose) and Dfraction led to a 42-percent growth decrease in AGS stomach-cancer cells, compared with a 21 percent reduction by the drug alone. Lung 3 DF's combination with the drug Cisplatin (100 µM dose) did not enhance the drug's antiproliferative activity on A549 lung-cancer cells (up to only 34-percent growth decrease, compared with 30-percent reduction by the drug alone), in addition to other findings. “Besides its efficacy as an adjuvant treatment for certain cancers, D-fraction is safe,” says Dr. Konno. “It has been exempted from a phase I study (toxicology tests) by the U.S. Food and Drug Administration. D-fraction also appears to work with less chemotherapy, and when used in combination with chemo may consequently help patients experience less chemotherapy side-effects.” Dr. Balogh and Colleagues' Cancer-Treatment Research Results** Dr. Balogh and colleagues' recent research** found that D-fraction (DF) reduces breastcancer cell viability (ability to survive) by increasing the number and activity of the BAK-1 gene, which is known to promote apoptosis (programmed cell death). The goal was to measure the effect the extract had on cell viability and apoptosis. In their study, human, MCF7 breast-cancer cells were treated with DF at 5, different concentrations (low to high, 10 µg /mL to 367 µg /mL), or were left untreated, for 24 hours. The result was decreased, MCF7 cell viability in a dose-dependent manner, which means that the more of the D-fraction that was used, the more pronounced the effect. Cell apoptosis was statistically significantly increased in a dose-dependent manner at every concentration tested. Analysis also showed that 22 apoptosis-promoting genes were found to be up-regulated. And at the highest dose, a 25-fold increase in the "cell death" BAK-1 gene was discovered. "These findings confirm the apoptotic effect of D-fraction in breast cancer cells," Dr. Balogh and her colleagues wrote. “The future for mushrooms as a nutritional supplement looks bright as long as clinical studies continue to support the mushroom’s properties as a powerful healing agent with the ability to improve human health.” About Mushroom Wisdom, Inc. Mushroom Wisdom, Inc. (formerly Maitake Products, Inc.), www.mushroomwisdom.com, is a global leader in the development, production and research of medicinal mushroom supplements. The company introduced the Maitake mushroom to America in 1991. It is celebrating its 20th Anniversary during 2011. 4 Mushroom Wisdom brings the healthful benefits of medicinal mushrooms, backed by rigorous scientific research, to the daily routines of consumers worldwide. It offers a complete product line, including specific medicinal mushroom products developed to support the immune system, brain function, blood sugar levels, breast health, prostate health and more.*** Maitake D-Fraction® is the registered trademark of Mushroom Wisdom, which holds the exclusive right to use the trade name. The company was founded in 1991 by President & CEO Mike Shirota and Vice President Tomoko Nakamura. Its headquarters are in East Rutherford, New Jersey. * Dr. Konno's research was sponsored by Mushroom Wisdom, Inc. ** J Med Food. 2011 Jun;14(6):563-72. Epub 2011 Apr 11. Maitake (D fraction) mushroom extract induces apoptosis in breast cancer cells by BAK-1 gene activation. Soares R, Meireles M, Rocha A, Pirraco A, Obiol D, Alonso E, Joos G, Balogh G. Source Department of Biochemistry, Faculty of Medicine, University of Porto Foundation, Porto, Portugal. www.ncbi.nlm.nih.gov/pubmed/21480800 *** These statements have not been evaluated by the U.S. Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease. 5