MONTREAL, Aug. 1 /CNW Telbec/ - 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
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,
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
About Beaumont Hospitals' Cancer Clinical Trials Office in Royal Oak,
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.