Key Developments: Oncolytics Biotech Inc (ONCY.PH)

ONCY.PH on Philadelphia Stock Exchange

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22 Jul 2014
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Latest Key Developments (Source: Significant Developments)

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

Oncolytics Biotech Inc Announces Positive Top Line Reolysin Data For First Endpoint In Randomized Phase III Study In Head And Neck Cancers
Thursday, 13 Dec 2012 06:30am EST 

Oncolytics Biotech Inc announced initial positive top line data from the first endpoint in its double-blinded randomized Phase III clinical study examining REOLYSIN in combination with carboplatin and paclitaxel in second-line patients with platinum-refractory, taxane-naïve head and neck cancers (REO 018). The endpoint examines initial percentage tumour changes between the pre-treatment and first post-treatment scans (typically performed at six weeks post-first treatment) of all patients enrolled in the study. The analysis was designed to assess early differences in response between loco-regional tumours and metastatic tumours, as classified and observed by the investigators. This is the first, and to this point only, endpoint to be un-blinded for this study. The first analysis compared the relative percentages of patients in the test and control arms with tumours that had either stabilized or exhibited shrinkage. For the purposes of this endpoint, the definition of tumour stabilization was restricted to 0%growth only. Of the 105 total patients with evaluable metastatic tumours, 86% (n=50) of those in the test arm of the study exhibited tumour stabilization or shrinkage, compared with 67% of patients (n=55) in the control arm. This was significant, with a p-value of 0.025. The second analysis examined the magnitude of tumour response on a per patient basis using a comparison of percentage tumour shrinkage at six weeks in each patient with evaluable metastatic tumours.  Full Article

Oncolytics Biotech Inc Announces Appointment Of Chief Financial Officer
Monday, 12 Nov 2012 06:30am EST 

Oncolytics Biotech Inc announced the appointment of Mr. Kirk Look to the role of Chief Financial Officer.  Full Article

Oncolytics Biotech Inc Meets Primary Endpoint For First Stage Of US. Phase 2 Squamous Cell Lung Cancer Clinical Trial
Thursday, 13 Sep 2012 06:30am EDT 

Oncolytics Biotech Inc announced preliminary results from its U.S. Phase 2 clinical trial in patients with squamous cell carcinoma of the lung (SCCLC) using intravenous administration of REOLYSIN in combination with carboplatin and paclitaxel (REO 021). The Principal Investigator is Dr. Alain Mita of Cedars-Sinai Medical Centre in Los Angeles, CA. Eligible patients include those with metastatic stage IIIB, or stage IV, or recurrent squamous cell carcinoma of the lung who are chemotherapy naïve for their metastatic or recurrent cancer. The primary objective of the Phase 2 trial is to assess the antitumor 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 in the study population; to determine the proportion of patients receiving the above treatment who are alive and free of disease progression at six months; and to assess the safety and tolerability of the treatment regimen in the study population. The study is a two stage design. Up to 19 evaluable patients with SCCLC were to be treated in the first stage. If four or more patients demonstrated a partial response (PR) or better, the study would then proceed to the second stage, with up to 55 patients being treated in the entire study. This endpoint was met after 15 evaluable patients were enrolled. The Company is proceeding with the second stage of the study.  Full Article

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