MONTREAL, Aug. 1 /PRNewswire-FirstCall/ -- Immunotec Inc. (TSX-V: IMM) announced today that the U.S. Food and Drug Administration has approved an investigator-held IND (#105,140) for the conduct of this pilot study of 48 patients. The goal of the study is to determine the effect of IMN 1207, a cysteine-rich whey protein supplement, in preventing additional weight loss in patients with stage IV (advanced) non-small cell lung cancer. Many patients with cancer struggle with severe cancer-related weight loss and decline in their general health. This study proposes that the use of IMN 1207, could potentially maintain or increase weight in patients with advanced non-small cell lung cancer (NSCLC). The study will compare the use of IMN 1207 with casein, another protein that is derived from milk.
IMN 1207 is an advanced formulation of the undenatured whey protein, Immunocal(R), a dietary natural health supplement developed and sold worldwide by Immunotec for the past 12 years. Depending on the results of this study, larger trials evaluating the effect of IMN 1207 may be warranted.
Lung cancer is the leading cause of cancer-related deaths in the United States. The majority of the diagnosed lung cancers (85%) are non-small cell lung carcinomas. These cancers have a high risk of weight loss (61%), as do pancreatic and gastric cancers. Disease and/or treatment-related weight loss may trigger a cascade of secondary effects including reduced quality of life, treatment intolerance and infections, as well as decreased survival.
Research studies using various drugs such as megestrol acetate, a steroid hormone, have reported successful weight gain, but it can be associated with potentially serious side effects (such as high blood pressure, blood clots, etc). Therefore investigating a nutritional supplement with few side effects is important.
Data from a previous study conducted by Tozer and colleagues suggested that treatment with IMN 1207 may promote weight gain in patients with lung cancer. For the complete publication, see (Tozer et al. Cysteine-Rich Protein Reverses Weight Loss in Lung Cancer Patients Receiving Chemotherapy or Radiotherapy. Antioxid Redox Signal. 2008 Feb; 10(2): 395-402.).
The study chairs, Shannon Wills, Ph.D., clinical research associate and David Decker, M.D., a medical oncologist at Beaumont Hospitals, are enthusiastic about the prospects of this study; "Cancer-related weight loss not only contributes to a decline in the quality of life and survival of patients with lung cancer, but also causes psychological distress for patients and their families. Research like this is essential to identify better interventions to address cancer-related weight loss and we are pleased to participate in this study."
This study, supported by the Moffitt Cancer Center CCOP Research Base, which is funded by NCI, will only be conducted through the Beaumont CCOP, part of the Cancer Clinical Trials Office at Beaumont Hospitals in Royal Oak, Michigan.
About the Moffitt CCOP Research Base
Funded by the National Cancer Institute's Division of Cancer Prevention in 2000, this Research Base is dedicated to the development and conduct of cancer prevention and cancer control clinical trials. The Research Base serves a diverse patient population through membership of NCI-funded Community Clinical Oncology Programs , Minority-Based CCOPs , striving to help prevent or reduce cancer's burden on individuals and families and to improve their quality of life. Offices of the Moffitt CCOP Research Base are located on the University of South Florida's Tampa campus. http://ccoprb.epi.usf.edu/
About Beaumont CCOP in Royal Oak, Michigan
The National Cancer Institute has designated Beaumont Hospitals as a Community Clinical Oncology Program , one of about 50 in the country that connect academic centers with community physicians who enroll patients in medical research. Beaumont CCOP is a department of the Beaumont Research Institute.
About Beaumont Hospitals' Cancer Clinical Trials Office in Royal Oak, Michigan
The Beaumont Cancer Institute at Beaumont Hospitals is a Blue Distinction Center for Complex and Rare Cancers, as designated by Blue Cross/Blue Shield. The Michigan Cancer Consortium bestowed a Spirit of Collaboration Award on the Beaumont Cancer Institute's Minority Outreach Program in 2007.
About Immunotec Inc.
Immunotec is engaged primarily in the development and marketing of natural health products, dietary supplements, vitamins and personal care products, many of which are manufactured on its behalf by third parties. Immunotec's products are distributed and sold in the United States and Canada through a network marketing system and in other countries through exclusive distributorship agreements. Immunotec's investment in this study is another manifestation of its ongoing commitment to research and development.
IMMUNOTEC INC.
CONTACT: Immunotec Media contact: John H. Molson, Vice-President,
Research Development, (450) 510-4450, Fax: (450) 424-9993,
jmolson@immunotec.com; Clare Malbon, R D Dept., (450) 424-9992 ext 2377
