Key Developments: Oncolytics Biotech Inc (ONCY.PH)

ONCY.PH on Philadelphia Stock Exchange

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17 Dec 2014
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Latest Key Developments (Source: Significant Developments)

Oncolytics Biotech Inc announces filing for Orphan Drug Designation with U.S. FDA for Pancreatic and Ovarian Cancers
Tuesday, 2 Dec 2014 06:30am EST 

Oncolytics Biotech Inc:Has submitted applications for Orphan Drug Designation to the U.S. Food and Drug Administration (FDA) for REOLYSIN for the treatment of pancreatic and ovarian cancers.  Full Article

Oncolytics Biotech Inc announces entry into $20 million at-the-market equity distribution agreement with Canaccord Genuity Inc
Friday, 24 Oct 2014 05:13pm EDT 

Oncolytics Biotech Inc:Enters into an at-the-market (ATM) equity distribution agreement with Canaccord Genuity Inc. acting as sole agent.Under the terms of the distribution agreement, the Company may, from time to time, sell shares of its common stock having an aggregate offering value of up to $20 mln through Canaccord Genuity Inc.Company will determine, at its sole discretion, the timing and number of shares to be sold under this ATM facility.  Full Article

Oncolytics Biotech Inc collaborators present translational brain cancer clinical data and immunomodulatory preclinical research at UK Oncolytic Virus Conference
Friday, 11 Apr 2014 06:30am EDT 

Oncolytics Biotech Inc:Says Dr. Alan Melcher, Professor of Clinical Oncology and Biotherapy at the University of Leeds, presented at the 8(th) Annual International Conference on Oncolytic Virus Therapeutics held in Oxford, UK.Melcher's presentation, titled Clinical Virotherapy and Immune Modulation; Bench to Bedside and Back Again.Melcher also outlined two planned clinical studies.First is a biological endpoint study examining the use of REOLYSIN with or without GM-CSF in patients with advanced melanoma prior to resection.Second is a trial of REOLYSIN and GM-CSF in combination with chemoradiation following surgery for high grade gliomas.  Full Article

Oncolytics Biotech Inc announces additional data from REO 018 Randomized Study of REOLYSIN in head and neck cancers
Tuesday, 8 Apr 2014 06:30am EDT 

Oncolytics Biotech Inc:Additional data from company's randomized, double-blinded clinical study examining REOLYSIN in combination with carboplatin and paclitaxel in patients with second-line, platinum-refractory, taxane-naïve head and neck cancers (REO 018).The REO 018 study enrolled a total of 167 patients. Patients on the control arm were treated with carboplatin, paclitaxel and a placebo, while those on the test arm were treated with carboplatin, paclitaxel and REOLYSIN.Data was available for 165 patients, and was analyzed on an intent-to-treat basis.  Full Article

Oncolytics Biotech Inc Meets Primary Endpoint For First Stage Of U.S. Phase 2 Metastatic Melanoma Trial
Wednesday, 22 May 2013 06:30am EDT 

Oncolytics Biotech Inc announced preliminary results from its U.S. Phase 2 clinical trial in patients with metastatic melanoma using intravenous administration of REOLYSIN in combination with carboplatin and paclitaxel (REO 020). The Principal Investigator is Dr. Devalingam Mahalingam, M.D., Ph.D., MRCP(UK), MRCP(I), clinical investigator in GI/thoracic oncology and drug development at the Cancer Therapy & Research Center at the University of Texas Health Science Center (CTRC). Eligible patients include those with metastatic malignant melanoma who have failed one or more prior therapies or those not considered a candidate for standard first line therapy. The primary objective of the Phase 2 trial is to assess the antitumour effect of the treatment regimen in the study population in terms of objective response rates. The secondary objectives are to assess progression-free survival and overall survival for the treatment regimen; the disease control rate (complete response (CR) plus partial response (PR) plus stable disease (SD)) and duration, and to assess the safety and tolerability of the treatment regimen in the study population. The study is a two stage design. Up to 18 evaluable patients with metastatic melanoma were to be treated in the first stage. If three or more patients demonstrated a PR or better, the study could then proceed to the second stage, with up to 43 patients being treated in the entire study.  Full Article

Oncolytics Biotech Inc Meets Primary Overall Statistical Endpoint in U.S. Phase 2 Study of REOLYSIN in Squamous Cell Lung Cancer
Thursday, 28 Mar 2013 06:30am EDT 

Oncolytics Biotech Inc announced that it has met the primary overall statistical endpoint in its U.S. Phase 2 single arm clinical trial in patients with squamous cell carcinoma of the lung (SCCLC) using intravenous administration of REOLYSIN in combination with carboplatin and paclitaxel in patients with metastatic stage IIIB, or stage IV, or recurrent SCCLC who are chemotherapy naïve for their metastatic or recurrent cancer (REO 021). The study is a two-stage design with a primary overall endpoint of objective tumor response rate. The Company saw a sufficient number of responses in the first stage of the study to proceed with enrollment in the second stage. A total of up to 36 patients were to be studied in the second stage. The primary endpoint was met if nine or more patients in both stages combined had a partial response (PR) or better, which yields a true response rate of 35% or more. This endpoint was met after 21 evaluable patients were treated on study, nine of which exhibited PRs, while a further nine showed stable disease (SD) and three, progressive disease (PD), for a response rate of 42.8% and a disease control rate (complete response (CR) + PR + SD) of 85.7%.  Full Article

Oncolytics Biotech Inc Announces Closing Of Common Share Offering
Monday, 25 Feb 2013 11:51am EST 

Oncolytics Biotech Inc announced that it has closed its previously announced underwritten public offering of 8.0 million common shares, at a public offering price of $4.00 per common share. The aggregate gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses payable by Oncolytics, were approximately $32.0 million.The offering was conducted by Piper Jaffray & Co. and Wedbush PacGrow Life Sciences acting as joint book-running managers for the offering in the U.S. and Paradigm Capital Inc. acting as co-manager in the U.S. and book-running manager in Canada.Oncolytics intends to use the net proceeds from the offering to fund its clinical trial program, manufacturing program and for general corporate and working capital purposes.  Full Article

Oncolytics Biotech Inc Announces Pricing Of Common Share Offering
Wednesday, 20 Feb 2013 09:00am EST 

Oncolytics Biotech Inc announced that the pricing of an underwritten public offering of 8.0 million common shares, at a public offering price of $4.00 per common share. The Company estimates that the gross proceeds from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Oncolytics, will be $32.0 million. The offering is expected to close on or about February 25, 2013, subject to customary closing conditions.Piper Jaffray & Co. and Wedbush PacGrow Life Sciences are acting as joint book-running managers for the offering in the U.S. and Paradigm Capital Inc. is acting as co-manager in the U.S. and book-running manager in Canada. The Company has granted to the underwriters participating in the offering a 30-day option to purchase up to an additional 1.2 million common shares to cover over-allotments, if any. Oncolytics intends to use the net proceeds from the offering to fund its clinical trial program, manufacturing program and for general corporate and working capital purposes.  Full Article

Oncolytics Biotech Inc Announces Common Share Offering
Tuesday, 19 Feb 2013 04:01pm EST 

Oncolytics Biotech Inc announced its intention, subject to market and other conditions, to commence an underwritten public offering of common shares. The number of common shares to be distributed and the price of each common share will be determined in the context of the market with final terms to be determined at the time of pricing. Piper Jaffray & Co. and Wedbush PacGrow Life Sciences will act as joint book-running managers for the offering in the U.S. and Paradigm Capital Inc. will act as co-manager in the U.S. and book-running manager in Canada. The Company expects to grant the underwriters participating in the offering a 30-day option to purchase up to an additional 15% of the number of common shares sold pursuant to the offering to cover over-allotments, if any. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Oncolytics intends to use the net proceeds from the offering to fund its clinical trial program, manufacturing program and for general corporate and working capital purposes.  Full Article

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