Non-Small Cell Lung Cancer

Lung cancer is the third most common cancer and the most common cause of cancer-related mortality in the U.S. It is estimated that 234,030 new cases of lung and bronchus cancer will be diagnosed in 2018 and that 154,050 people will die from the disease. While it is widely recognized that smoking is a main cause of lung cancer, new cases, deaths and 5-year survival rates have not markedly improved since 1975 (1,2).

There are two types of lung cancer, small cell and non-small cell lung cancer. The vast majority of patients, 85%, are diagnosed with non-small cell lung cancer (NSCLC), which amounts to an estimated 198,925 new cases in 2018. Radiation therapy alone (for limited disease) or combined with chemotherapy (for extensive disease) is the standard treatment for NSCLC. It is estimated that 37% of early stage and 58% of late stage NSCLC patients receive radiation therapy (2).

NSCLC statistics are particularly grim as it represents more than half of all new invasive cancers diagnosed. In addition, as most of these present at locally advanced stages this cancer results in about one-third of all cancer deaths (1).  Radiation dose escalation for NSCLC is particularly difficult due to the close proximity of critical organs. Thus, patients with NSCLC would benefit greatly from a therapy such as BIO 300 that could protect the normal tissues near the cancer site(s), while also increasing the effectiveness of radiation therapy.

Nonclinical Data

Nonclinical studies confirm that BIO 300 can protect normal tissue from radiation, while acting additively with radiation to kill tumors.  Pulmonary tissue is known to undergo extensive damage and tissue remodeling following radiation exposure.  In these studies, lung tissue exposed to radiation therapy shows signs of congestion, cellular infiltration and other evidence of tissue damage, which is not evident after BIO 300 treatment. Importantly, BIO 300 can act additively with radiation to cause cancer cell death and significantly increases tumor growth delay compared to the respective controls.

 

 

Clinical Study - Phase 1b/2a

BIO 300 Non-Small Cell Lung Cancer Study (NSCLC) is currently recruiting participants. The purpose of this study is to determine the safety and effectiveness of BIO 300 Oral Suspension when used in combination with standard dose radiation therapy and chemotherapy in patients with non-small cell lung cancer.

Collaborators:

National Cancer Institute (NCI)
Henry Ford Health System - Detroit, MI
Medical College of Wisconsin - Milwaukee, WI
University of Maryland School of Medicine - Baltimore, MD
Ochsner Clinic - New Orleans, LA

More details are available at ClinicalTrials.gov:  https://clinicaltrials.gov/ct2/show/NCT02567799

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor should visit the study site on ClinicalTrials.gov.  For general information, see Learn About Clinical Studies.

  1. American Cancer Society. Cancer Facts & Figures 2018. Atlanta: American Cancer Society, 2018.
  2. Miller KD, Siegel RL, Lin CC, Mariotto AB, Kramer JL, Rowland JH, Stein KD, Alteri R, Jemal A. Cancer treatment and survivorship statistics, 2016. CA Cancer J Clin. 2016;66(4):271-89. Epub 2016/06/03. doi: 10.3322/caac.21349. PubMed PMID: 27253694.