"Oncolytics experienced a strong second quarter with the reporting of durable clinical responses to REOLYSIN® combination therapy treatment in refractory head and neck cancer patients," said Dr. Brad Thompson, President and CEO of Oncolytics. "We are enrolling increasing numbers of patients in our clinical program for REOLYSIN®, and the positive results from these trials are helping us to plan the later-stage development program for REOLYSIN®."
Second Quarter Highlights
Significant Clinical Advances
- Presented positive interim U.S. Phase II sarcoma trial results at the
American Society of Clinical Oncology (ASCO) annual meeting, showing 8
of 16 evaluable patients experienced stable disease for periods
ranging from two to more than ten, 28-day cycles.
- Presented positive interim results from a U.K. combination REOLYSIN®
and paclitaxel/carboplatin trial at the British Society of Gene
Therapy (BSGT) conference in Edinburgh. Three head and neck patients
evaluated at that time had excellent clinical and radiological
responses without appreciable toxicity. The dose escalation portion of
this trial was completed in the second quarter.
- Received approval for U.K. and U.S. Phase II clinical trials
investigating REOLYSIN® in combination with paclitaxel and
carboplatin, and started patient enrolment in the U.K. trial.
- The U.S. National Cancer Institute started patient enrolment in a
Phase I/II ovarian, peritoneal and fallopian tube cancer trial using
systemic and intraperitoneal administration of REOLYSIN®.
- Started patient enrolment in a U.K. combination REOLYSIN® and
cyclophosphamide trial.
- Subsequent to the quarter end, announced that the 200th patient had
been treated with REOLYSIN®.
Preclinical Advances
- Two presentations were delivered at the American Society of Gene
Therapy (ASGT) meeting covering work using the reovirus against
mesothelioma, and also to purge lymph nodes of tumor cells.
- Another two presentations were delivered at the American Association
for Cancer Research (AACR) covering work using the reovirus in
combination with radiation for pediatric sarcomas, and reovirus as a
purging agent for autologous stem cell transplants.
- A paper covering preclinical work demonstrating that reovirus can kill
melanoma cell lines and freshly resected tumour was published in Gene
Therapy.
- A paper covering preclinical work demonstrating that reovirus can
activate dendritic cells to promote innate, antitumor immunity was
published in the Journal of Immunology.
Manufacturing
- Successfully transferred cGMP production of REOLYSIN® at the
40-litre batch size to SAFC Pharma(TM), a Division of Sigma-Aldrich
Corporation. Yields at the 40-litre scale should provide sufficient
doses to support future development plans leading to registration and
also early-stage commercial requirements. Development work at the 100-
litre scale is continuing.
Intellectual Property
- One U.S. patent and one Canadian patent were secured in the second
quarter. Oncolytics has secured more than 180 patents worldwide,
including 27 U.S. patents and 9 Canadian patents.
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