Effect of IMN1207 Versus Casein on Weight Loss, Survival and Quality of Life in Non-small Cell Lung Cancer Patients

Effect of IMN1207 Versus Casein on, Weight Loss, Survival and Quality of Life in Non-small Cell Lung Cancer Patients During or Following Chemotherapy, Radiation or Surgery: A Multi-center Randomized, Double-blind Study - Phase III Trial

The primary aim of this IMN 1207 follow-up study is to confirm the effect of a cysteine-rich non-denatured whey protein isolate formulation IMN1207 (20g daily) versus casein (20 g daily) on the reversal of weight loss (cancer-related wasting) over a 40 week treatment period in non-small cell lung cancer patients with or without conventional therapy, i.e., chemotherapy or radiation. And to test the hypothesis that over a period of 66 weeks observation period which includes a 6 months follow-up period, increases the survival of these patients.

This new IMN 1207 study is a follow-up study to the first IMN 1207 trial which was sponsored by Immunotec Inc during the last 3 years. The study revealed that the cysteine-rich whey protein isolate formulation IMN 1207 caused a significant reversal of weight loss (P <0.05) and a conspicuous increase in survival. The outcome of the first IMN 1207 study has been published in (Tozer RG, 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). PMID:18158761.

The purpose of this IMN 1207 follow-up study is to confirm the effect of a cysteine-rich non-denatured whey protein isolate formulation IMN1207 (20g daily) versus casein (20 g daily) on the reversal of weight loss (cancer-related wasting) over a 40 week treatment period in non-small cell lung cancer subjects with or without conventional therapy, i.e., chemotherapy or radiation. In addition, it is prospectively designed to test the hypothesis that, IMN1207 versus casein over a period of 66 weeks observation period which includes a 6 months follow-up period, increases the survival of these subjects. Also, the effect of IMN1207 on the quality of life in a defined subgroup of subjects will be determined.

Inclusion Criteria:

• Non small cell lung cancer stage III or stage IV.
• Karnofsky performance status greater or equal to 70%.
• Expected participation in study for more than 3 months.
• Involuntary decrease in body weight of more than 3% over the 1-5 months period immediately preceding study entry.
• Age 18 or older.
• Serum creatine less or equal to 3.0mg/dL or 265 µmol/L.
• Total bilirubin in the normal range (0.2-1.2 mg/dL) SGPT equal to or less than 4 times the upper limit of normal.
• Reliable contraception (ovariectomy, hysterectomy, tubuligation for at least six months, oral contraceptive, barrier method, etc.) for women of child bearing potential.

Exclusion Criteria:

• History of angioedema or allergic reactions to any compound employed in this study.
• Pregnancy and lactating.
• Uncontrolled metastatic brain tumors.
• Milk protein intolerance.
• Subjects currently using N-acetylcysteine, alpha-lipoic acid supplements, or dry whey protein supplements.
• Presence of ascitis or edema according to principle investigator's clinical judgment.
• Significant anemia, as defined by the requirement of treatment with EPO.
• Subjects with either mild or soy allergy/intolerance.