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 221,200 new cases of lung and bronchus cancer will be diagnosed in 2015 and that 158,040 people will die of 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, 7 out of 8, are diagnosed with non-small cell lung cancer (NSCLC), which amounts to an estimated 193,550 new cases in 2015. 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.

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 (3).  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 would increase the effectiveness of radiation therapy and protect the vital organs near the cancer site(s).

Preclinical Data

Preclinical studies confirm that BIO 300 can protect normal tissue from radiation, while sensitizing tumors to the same treatment. BIO 300’s ability to sensitize tumors to radiation-induced killing has been demonstrated in a murine xenograft model of NSCLC cancer. In these same 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 significantly increases tumor growth delay compared to the respective controls.

Additional results pending publication.

Clinical Study - Phase I/II

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

More details are available 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 may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Contact: Diane Snell, MT, RA  (313) 916-3124  

  1. Cancer of the Lung and Bronchus - SEER Stat Fact Sheets. Available at: http://seer.cancer.gov/statfacts/html/lungb.html. (Accessed: 22nd April 2014).
  2. Pillai, R. N. & Owonikoko, T. K. Small cell lung cancer: therapies and targets. Semin. Oncol. 41, 133–42 (2014).
  3. Glide-Hurst, C. K. & Chetty, I. J. Improving radiotherapy planning, delivery accuracy, and normal tissue sparing  using cutting edge technologies. Journal of Thoracic Disease 6  303–318 (2014).