ASCO poster presentation Unveils Preliminary results of Phase I Clinical Trial involving Intravenous Administration of GL-ONC1 to Patients with Advanced Solid Tumor Cancers

    Preliminary results of the Phase 1 study being conducted at Royal Marsden Hospital (Surrey, UK) involving intravenous administration of GL-ONC1 in patients with advanced solid tumor cancers were presented during poster sessions by the study’s principal investigators* at three international meetings in late 2010 and at the American Society of Clinical Oncology (ASCO) meeting in Chicago in June 2011. While the clinical trial is ongoing and in its final stages, the following summary of preliminary results [http://genelux.com/files/ASCO-poster-Final.jpg] was presented at ASCO.

  • GL-ONC1 is well-tolerated with minimal toxicity
  • One dose limiting toxicity has been observed in 24 pts. This pt received treatment at the 1×109 pfu dose level and developed a short-lived grade 3 rise in aspartate transaminase that required no treatment after a single infusion.
  • There was an increase in Nab in all except one patient. VPA of blood, urine, stool and sputum were negative for viral shedding in all except one patient.
  • GFP expression was observed in man
  • A rash comprising of vaccinia pustules appeared in two pts during cycle 1 and resolved without treatment at the end of cycle 1. It was positive for GL-ONC1 viral plaque assay (VPA) and GFP imaging expression. This is the first study to demonstrate GFP expression in man.
  • Systemically-administered GL-ONC1 survived the body’s innate immune response and arrived at the tumor
  • In one patient with Squamous Cell Carcinoma of the base of tongue (1×107pfu) a submental biopsy showed positive Immunohistochemistry (IHC) staining after four cycles of treatment which was described as a “very focal moderate true positivity mainly around the tumour islands and occasionally within the tumour islands.”
  • Early signs of anti tumor activity in a variety of tumor types
    1. Best response was stable disease at 34 weeks for one pt, 24 weeks in two pts and 8-12 weeks observed in six pts. The stable disease was seen in colorectal rectal cancer (n=2), head & neck (n=2), chondrosarcoma (n=1), parotid (n=1), thyroid (n=1), esophageal (n=1) and renal cell carcinoma (n=1).
    2. Conclusion: Systemically-administered GL-ONC1 is well tolerated with minimal toxicity and preliminary evidence of anti-tumour activity.

      Poster entitiled: A Phase I clinical trial of a genetically modified and imageable oncolytic vaccinia virus GL-ONC1 with clinical green fluorescent protein (GFP) imaging; Presented by: Joanna Vitfell-Pedersen, Elena Karapanagiotou, Andrea Biondo, Martina Puglisi, Katie Denholm, Nina Tunarin, Salem Sassi, Johann De-Bono and Kevin Harrington (Royal Marsden Hospital NHS Foundation Trust/Institute of Cancer Research, Sutton, Surrey, United Kingdom)