Oncolytics Biotech Inc. Announces Initiation of U.S. Phase 2 Clinical Trial in Squamous Cell Carcinoma of the Lungs

Strategic Insights -

Oncolytics Biotech Inc., a Calgary-based biotechnology company, has announced the initiation of a U.S. Phase 2 clinical trial using its proprietary formulation of the human reovirus, REOLYSIN, in combination with carboplatin and paclitaxel in patients with squamous cell carcinoma of the lungs. The trial, led by Dr. Alain C. Mita of the Cancer Therapy & Research Center at the University of Texas Health Science Center, aims to assess the antitumor effect of the treatment regimen in patients with metastatic stage IIIB, stage IV, or recurrent squamous cell carcinoma of the lung.

Key Takeaways:

  • The Phase 2 trial will enroll up to 55 patients with squamous cell carcinoma of the lungs who are chemotherapy naive for their metastatic or recurrent cancer.
  • The primary objective of the trial is to assess the antitumor effect of the treatment regimen in terms of objective response rates.
  • Secondary objectives include assessing progression-free survival and overall survival for the treatment regimen in the study population.
  • The trial is part of a broader preclinical and clinical collaboration with the Cancer Therapy & Research Center that will involve up to five, open-label, Phase 2 studies exploring the use of REOLYSIN in combination with chemotherapy for various cancer indications.
  • The Cancer Therapy & Research Center at the University of Texas Health Science Center is one of the nation's leading academic research and treatment centers, with a reputation for developing new drugs to treat cancer.
  • Oncolytics Biotech Inc. is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics, with a clinical program that includes a Phase III trial in head and neck cancers using REOLYSIN.
  • The American Cancer Society estimates that in 2009, there were approximately 219,440 new cases of lung cancer, with squamous cell carcinomas accounting for 25-30% of all lung cancers.

Statistics:

  • 85% of all lung cancers are classified as non-small cell lung cancer (NSCLC).
  • Lung cancer is by far the leading cause of cancer death among both men and women, with an estimated 159,000 deaths in 2009, accounting for around 28% of all cancer deaths.
  • Up to 55 patients are expected to be treated in the Phase 2 trial.

Sources:

  • Oncolytics Biotech Inc. press release
  • The Cancer Therapy & Research Center at the University of Texas Health Science Center website
  • American Cancer Society website
  • Oncolytics Biotech Inc. website