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Thomas Lynch received a B.S. Degree in Chemistry from Wheeling College in 1968. For two years he worked at the Sloan-Kettering Institute for Cancer Research, Rye, N.Y. In 1975 he received his Ph.D. in Bacteriology for membrane structure and function, mainly lipid and protein biochemical... More
  • Oncolytics REOLYSIN On The RAS Warpath 0 comments
    Sep 20, 2009 6:15 PM | about stocks: F

     Six months ago, I wrote in Seeking Alpha (Pivotal Cancer Treatment: Enclitics Likely to Succeed), that Oncolytics Biotech. Inc. (ONCY), has been advancing it’s  reovirus, REOLYSIN(NYSE:R), as a treatment therapy for all cancers expressing an activated RAS pathway.  At that time it was $1.32/share.  This past Friday, 9/18/09, it closed at  $3.17/share and gained $0.69 or 27.82% for the day.  Oncolytics Biotech issued a statement advising that they had not released any undisclosed information that may be contributing to the recent increase in market price and level of trading activity of its shares.  

    In the March 23, 2009 article, I briefly summarized some results of clinical trials which demonstrate that this ubiquitous double-stranded RNA (dsRNA)  oncolytic virus in combination with chemotherapy, (or with radiation, or as a mono therapy) selectively kills cancer cells while sparing normal cells.  This reovirus (for respiratory enteric orphan virus), which is not known to cause any disease in humans, although a majority of tested population have antibodies to it, replicates selectively in cells containing an activated RAS pathway .  

    Approximately two thirds of human cancers contain an activated RAS pathway, including most metastatic disease, and thus are potential targets for infection and oncolytic destruction by REOLYSIN.  Frequently in metastatic cancers, the secondary tumors result in death.  In addition to the direct lytic action as a result of progeny virus bursting the cell membrane of cancer cells, evidence has emerged that indicates that cytolytic action by the immune system towards tumors likely assists the favorable results that have emerged during clinical trials observed in various human tumors.  Nine clinical Phase II trials are were being carried out when the previous article was written and Oncolytics Biotech have stated that a pivotal Phase II/III randomized clinical trial with paclitaxel and carboplatin was to be initiated on patients with head and neck cancers. 

         In the last six months Oncolytics Biotech has reported in a 15 patient trial of intravenous administration of REOLYSIN in combination of gemcitabine a disease control rate (Complete response [CR]  +  Partial Response [PR] + Stable Disease [SD]) of 70%.  As a result of that treatment combination in late-stage cancer patients, an additional trial is planned for patients with advanced or metastatic pancreatic cancer.  A U.S. Phase 2 Combination REOLYSIN and paclitaxel/carboplatin clinical trial for patients with non-small cell lung cancer with KRAS or EGFR-activated tumors has been opened for  enrollment.  A U.K. translational clinical trial investigating REOLYSIN in patients with metastatic colorectal cancer has also been initiated.  A clinical benefit response rate of 93% was obtained in treated lesions of a U.K. Phase II combination radiation and REOLYSIN trial. 

    In all the clinical trials to date involving over 200 patients, they have not reached a maximum tolerated dose (NYSE:MTD) and some patients have had more than a dozen treatment cycles. Toxicity's related to REOLYSIN treatment have been generally mild (grade 1 or 2)  with transient grade 3 or 4 toxicity's lasting less than 6 hours, more flu-like symptoms than debilitating symptoms normally associated with cancer treatments.  

    Oncolytics announced that it has successfully completed an initial 100-liter production run of REOLYSIN under cGMP conditions and completed the lyophilization (freeze-drying) formulation development program a stable form for pharmaceutical distribution should their product be approved by the FDA.  Oncolytics has more than 200 patents issued worldwide which cover mainly reovirus and other oncolytic viruses (adenovirus, herpes simplex virus).  

    The FDA has revised labeling of the epidermal growth factor receptor (EGFR) class of antibodies indicating that colorectal patients who have a KRAS mutation in their tumors do not respond to EGFR-inhibiting antibodies and this class is thus not recommended for these patients.  As Oncolytics Biotech have stated, a significant clinical opportunity for REOLYISN is in the treatment of patients with metastatic cancers including colorectal and non-small cell lung cancer who have a mutated KRAS gene.  In addition to a mutated KRAS gene, there are a large number of mutations including EGFR, Her2 along the RAS pathway which lead to RAS pathway activation.  Destroying metastatic cells and tumors in patients, especially through synergistic combinations of  chemotherapeutic drugs or radiation treatment, offers the potential for patients to reduce their cancer cell burden and time for their immune systems to “reawaken” their cellular immune system to assist in destruction of malignant cells. 

    Even after the recent gain in price, I  believe Oncolytics Biotech is still a huge bargain when one considers its broad selectivity in killing cancer cells without replicating in or harming normal cells, its relatively benign side flue-like effects, and clinically proven arrest of certain metastatic cancers.  All clinical trials to date have clearly demonstrated a significant improvement of seriously ill cancer patients. I have no idea or feeling for ONCY as a short term trade, and am only regarding ONCY as a LONG term position.

    I have no association at all with Oncolytics Biotech but have owned the stock since 2002 based on the science of reovirus lytic destruction of RAS activated malignant cells.

    Stocks: F
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