Oncolytics Biotech

Oncolytics Biotech Inc. is a Canadian company headquartered in Calgary, Alberta, that focuses on the development of pharmaceutical products for the treatment of human cancers. The product Reolysin harnesses the oncolytic capabilities of naturally occurring reovirus (Respiratory Enteric Orphan virus), which has been shown to replicate specifically in cells with an activated Ras pathway. Ras pathway mutations are found in approximately two thirds of all tumours, including most metastatic disease, which makes Reolysin a potential therapeutic for cancer.

History

Oncolytics Biotech Inc. was founded in Calgary in 1998 in response to discoveries made on the oncolytic potential of reovirus made at the University of Calgary during the 1990s.^[1][2][3] From 1999 to 2000 the company transitioned from private to public ownership. In June 2000, it began trading on the Toronto Stock Exchange (TSE) and began trading on the NASDAQ in 2001.

Since its inception, Oncolytics Biotech Inc. has worked to take Reolysin, its proprietary formulation of human reovirus, through the development and regulatory requirements necessary to develop it as a potential cancer therapeutic. In 2000, Oncolytics Biotech Inc. received permission to conduct its first phase I clinical trial, which was designed to test the safety of Reolysin in human patients. The positive results^[4] of this first study led to the rapid and continuous expansion of Oncolytics’ clinical trial program, with phase II studies beginning in Canada in 2001, U.S. and subsequent cross-border studies beginning in 2002, and enrollment in a multi-site phase III trial beginning in 2010.^[5]

The company was issued its first Canadian patent in August 2000, and currently holds more than 200 patents worldwide, including 38 U.S. and 11 Canadian patents.

Products

Reolysin was developed from pre-clinical research done at the University of Calgary^[2][3] Matt Coffey and Jim Strong led this research, and as Oncolytics’ Chief Operating Officer, Coffey continues to play a pivotal role in the product’s development.

Reolysin is a proprietary formulation of human reovirus, which is naturally found in mammalian respiratory and bowel systems.^[6] Most people have been exposed to reovirus by adulthood, but the infection does not typically produce symptoms.^[7] Reovirus was noted to be a potential cancer therapeutic when early studies suggested it reproduces well in certain cancer cell lines.^[8][9] It has since been shown to replicate specifically in cells that have an activated Ras pathway with very little effect in cells that do not have active Ras pathways.^[10] Activating mutations of the Ras protein and upstream elements of the Ras protein may play a role in more than two thirds of all human cancers, including most metastatic disease, which suggests that Reolysin may be an effective therapeutic for many Ras-activated tumor types and potentially for some cell proliferative disorders.^[11][12][13]

Research and development collaborations

Oncolytics Biotech Inc. has collaborative agreements with the National Cancer Institute,^[14] the University of Leeds,^[15] and the Cancer Therapy & Research Centre at the University of Texas Health Science Center in San Antonio^[16] to conduct multiple phase I/II and phase II trials in the United States and United Kingdom. There are multiple active trials^[17] in the Company’s clinical program and these ongoing studies, along with the ones Oncolytics has successfully completed, are producing interim and final data that indicate positive clinical responses in multiple types of primary and metastatic disease.^{[18][19][20][21][22][23]}

On September 2, 2010, the Company announced that the Gynecologic Oncology Group (GOG) would be pursuing a new phase II study of Reolysin in combination with weekly paclitaxel in patients with persistent or recurrent ovarian, fallopian, or primary peritoneal cancer.^[14] The National Cancer Institute (NCI) in the United States has approved and will sponsor the study.

Reolysin clinical progress

Reolysin has completed phase I and II clinical trials across a variety of cancer types. The company is conducting a phase III trial examining Reolysin in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers. The phase III trial is being conducted in multiple jurisdictions:

• On October 2, 2009, the company announced that it had reached an agreement with the U.S. Food and Drug Administration (FDA) regarding the study design, making Oncolytics one of the first companies to reach an agreement with the FDA on a phase III trial design for an intravenously-administered oncolytic virus under the Special Protocol Assessment (SPA) process^[24]
• On February 16, 2010, the company announced that it has received a letter of approval to conduct the trial from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA)^[25]
• On June 1, 2010, the company announced that it had received approval to conduct the trial from the Belgian Federal Agency for Medicines and Health Products (FAMHP)^[26]
• On July 19, 2010, the company announced that it had received a no-objection letter to conduct the trial from Health Canada^[27]

The company is conducting phase II trials in a range of indications including squamous cell carcinoma of the lung, non-small cell lung cancer, pancreatic cancer, and ovarian cancer. The company is also conducting a phase I trial in colorectal cancer.

References

External links

• oncolyticsbiotech.com
• An interview of former CEO Brad Thompson on This Week in Virology
• A podcast feed with a number of company conference calls. (As explained in the text of the file, enter the .xml address into a podcast program. Alternatively, scroll down in the file to get the links to the audio .mp3 files directly. The feed comes from the company webpage at http://www.oncolyticsbiotech.com/for-investors/rss-feeds/default.aspx)
• Detailed notes explaining how an Oncolytics shareholder who is a US taxpayer can navigate the company's US tax status as a so-called "Passive foreign investment company" (PFIC).