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Oncolytics Biotech Inc. Message Board

  • starsearcher40 starsearcher40 Mar 5, 2013 7:24 AM Flag

    News

    2013-03-05 06:41 ET - News Release

    Dr. Brad Thompson reports

    ONCOLYTICS BIOTECH INC. COMPLETES PATIENT ENROLLMENT IN U.S. PHASE 2 STUDY OF REOLYSINATRADEMARK IN NON-SMALL CELL LUNG CANCER

    Oncolytics Biotech Inc. has completed patient enrolment in a phase 2 clinical trial evaluating intravenous administration of Reolysin in combination with paclitaxel and carboplatin in patients with non-small cell lung cancer with Kras or EGFR-activated tumours (REO 016).

    This trial is a single arm, single-stage, open-label, Phase 2 study of Reolysin given intravenously with paclitaxel and carboplatin every three weeks. Patients received four to six cycles of paclitaxel and carboplatin in conjunction with Reolysin, following which Reolysin could be continued as a monotherapy.

    Eligible patients included those with metastatic or recurrent NSCLC with Kras or EGFR-activated tumours, who had not received chemotherapy treatment for their metastatic or recurrent disease. Patients must have demonstrated mutations in Kras or EGFR, or EGFR gene amplification in their tumours (metastatic or primary) in order to qualify for the trial.

    The Company previously reported in November 2012 that 33 patients had received Reovirus (Reolysin) (3 x 1010 TCID50) intravenously daily on days one to five, in combination with carboplatin and paclitaxel. Molecular tumor demographics included: 16 Kras, three EGFR, four BRAF mutations, and 10 EGFR amplified only. Response evaluation data reported among 30 evaluable patients showed 27 patients had stable disease or better for a 90% clinical benefit rate (nine partial response (PR) (30%) and 18 stable disease (SD) (60%)). Three patients had progressive disease (PD) as their best response.

    "We have seen encouraging results in both this and other trials looking at primary and metastatic lung disease and are continuing to push our lung program forward on that basis," said Dr. Brad Thompson, President and CEO of Oncolytics. "We have extended our work in this ind

    Sentiment: Strong Buy

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    • Positive driving results, as already reported in today's News Release:

      "The Company previously reported in November 2012 that 33 patients had received Reovirus (REOLYSIN) (3 x 1010 TCID50) intravenously daily on days one to five, in combination with carboplatin and paclitaxel. Molecular tumor demographics included: 16 Kras, three EGFR, four BRAF mutations, and 10 EGFR amplified only. Response evaluation data reported among 30 evaluable patients showed 27 patients had stable disease or better for a 90% clinical benefit rate (nine partial response (PR) (30%) and 18 stable disease (SD) (60%)). Three patients had progressive disease (PD) as their best response."

    • News Release Continued:

      We have extended our work in this indication beyond this drug combination and are currently evaluating Reolysin in conjunction with docetaxel or pemetrexed in a second line open-label, randomized, non-blinded, Phase II clinical study sponsored by the NCIC Clinical Trials Group at Queen's University in Kingston, Ontario that will enroll up to 150 squamous cell and adenocarcinoma of the lung patients."

      Sentiment: Strong Buy

      • 1 Reply to starsearcher40
      • This brings the total number of trials that are enrolled, but have not reported survival data up to six:

        1) PIII head and neck, 6 months since last patient got on study
        2) PII H&N (north America) . 1 year, 9 months, and 5 days since last patient got on study
        3) PII NSCLC just finished enrollment
        4) PII panc with Gem and Reo: 6 months since last patient got on study
        5) PI colorectal: 6 months since last patient got on study
        6) PII Metastatic melanoma: 8 months since the last patient got on study

        This list will get PII Ovarian, PII Panc with CP-REO (NCI randomized), and maybe PII SSCLC this year.

        The value of the company is tied up in these data sets. As time goes, the OS for each of these trials relative to the SOC will come into view. It is already known for some of these at this point.

        BT will have up to 10 OS numbers by next year to manipulate potential partners with. If a pharma is dragging its feet in a negotiation, he can release another data set (oh, I'm sorry, the price just went up ... again ...... Can you here me now?)

 
ONCY
1.16+0.09(+8.41%)Mar 3 4:00 PMEST

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