CALGARY, AB, --- August 12, 2008 - Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) announced today that the U.S. National Cancer Institute (NCI), part of the National Institutes of Health, has started enrolment in a Phase 2 clinical trial for patients with metastatic melanoma using systemic administration of REOLYSIN®, Oncolytics’ proprietary formulation of the human reovirus. The trial is being carried out by the Mayo Phase 2 Consortium under the NCI’s Clinical Trials Agreement with Oncolytics, while Oncolytics will provide clinical supplies of Reolysin®. The Principal Investigator is Dr. Evanthia Galanis of the Mayo Clinic Cancer Center.
The primary objectives of the study are to assess the antitumour effects of Reolysin® in patients with metastatic malignant melanoma, as well as the safety profile of Reolysin®. Secondary objectives include assessment of progression free survival and overall survival.
Patients will receive systemic administration of REOLYSIN® at a dose of 3x10(10) TCID(50) per day on days 1-5 of each 28 day cycle, and patients may receive up to 12 cycles of treatment. The trial is expected to enroll up to 47 patients with metastatic melanoma.
Approximately 60,000 people are diagnosed with melanoma in the U.S. every year.
Tuesday, August 12, 2008
Wednesday, July 30, 2008
Oncolytics Biotech Inc. Announces 2008 Second Quarter Results
CALGARY, July 29 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) today announced its financial results and highlights for the three and six month periods ended June 30, 2008.
"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®."
"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.
For the entire text, please go here
Thursday, July 17, 2008
Oncolytics Biotech Inc. Treats 200th Cancer Patient in Clinical Studies with Reolysin
Ok, so this is a few days late, but I think most of you should have known about this already.
Monday July 14, 4:22 pm ET
- Company to Host Conference Call to Update Clinical Program -CALGARY, July 14
Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) announced today that it has now enrolled and treated 200 cancer patients in clinical studies with Reolysin®, its proprietary formulation of the human reovirus.
"The clinical program has gained substantial momentum in the past year, culminating in the treatment of our 200th patient this week," said Dr. Brad Thompson, President and CEO of Oncolytics. "Reolysin® has been well tolerated by the patients, and has demonstrated activity in all trials reported on to date. Our current studies will allow us to design our pivotal program based on Phase II data from human clinical studies."
Together with its collaborators, Oncolytics is now recruiting or enrolling patients in ten Phase I/II or Phase II clinical trials with Reolysin® in the U.S. and the U.K., and has permission to begin another Phase II trial in the U.S. These trials include four monotherapy trials using REOLYSIN® alone, and seven trials using Reolysin® in combination with radiation or chemotherapy.
Conference Call Details
Dr. Brad Thompson, President and CEO of Oncolytics, will host a conference call on Wednesday, July 16, 2008 at 11:30 a.m. MST (1:30 p.m. EST) to update investors on the Company's current and future clinical program for Reolysin®.
Tuesday, June 24, 2008
Article: In cancer war, viruses can be good guys
Interesting article worth checking out from McClatchy Newspapers.
Viruses aren't always the bad guys. Sure, they can cause colds, measles, AIDS and other miseries. But with some tinkering, these tiny organisms may become a new and better way to treat cancer.
...researchers are working with a harmless virus that sits in the lungs and intestines of most people. It's called a "reovirus," short for respiratory enteric orphaned virus. A Canadian company, Oncolytics Biotech, fiddles with reovirus genes to produce Reolysin, a virus that attacks a wide variety of cancers.
Read the full article here.
Viruses aren't always the bad guys. Sure, they can cause colds, measles, AIDS and other miseries. But with some tinkering, these tiny organisms may become a new and better way to treat cancer.
...researchers are working with a harmless virus that sits in the lungs and intestines of most people. It's called a "reovirus," short for respiratory enteric orphaned virus. A Canadian company, Oncolytics Biotech, fiddles with reovirus genes to produce Reolysin, a virus that attacks a wide variety of cancers.
Read the full article here.
Thursday, June 19, 2008
Oncolytics Biotech Inc. Announces U.S. Phase 2 Clinical Trial Investigating Reolysin in Combination with Paclitaxel and Carboplatin
CALGARY, June 20 - Oncolytics Biotech Inc. ("Oncolytics") announced today that following U.S. Food and Drug Administration (FDA) review, the Company is initiating a U.S. Phase 2 clinical trial using intravenous administration of REOLYSIN® in combination with paclitaxel and carboplatin in patients with advanced head and neck cancers. The Principal Investigator is Dr. Monica Mita of the Cancer Therapy and Research Center, University of Texas Health Science Center in San Antonio, Texas (CTRC at UTHSCSA).
"REOLYSIN® is one of the more exciting targeted agents under development in oncology," said Dr. Frank Giles, Director of the Institute for Drug Development. "Our investigators within the CTRC at UTHSCSA are very excited to begin studying potential synergy with standard cytotoxic agents and are eager to expand our studies into other tumor types and utilizing other chemotherapy partner regimens."
This trial is a 14-patient, single arm, open-label, dose-targeted, non-randomized trial of REOLYSIN® given intravenously in combination with a standard dosage of paclitaxel and carboplatin.
Eligible patients include those with advanced or metastatic head and neck cancers that are refractory to standard therapy or for which no curative standard therapy exists. The primary objective of the Phase 2 trial is to measure tumour responses and duration of response, and to describe any evidence of antitumour activity. The secondary objective is to determine the safety and tolerability of REOLYSIN® when administered in combination with paclitaxel and carboplatin to patients with advanced or metastatic head and neck cancers.
"REOLYSIN® is one of the more exciting targeted agents under development in oncology," said Dr. Frank Giles, Director of the Institute for Drug Development. "Our investigators within the CTRC at UTHSCSA are very excited to begin studying potential synergy with standard cytotoxic agents and are eager to expand our studies into other tumor types and utilizing other chemotherapy partner regimens."
This trial is a 14-patient, single arm, open-label, dose-targeted, non-randomized trial of REOLYSIN® given intravenously in combination with a standard dosage of paclitaxel and carboplatin.
Eligible patients include those with advanced or metastatic head and neck cancers that are refractory to standard therapy or for which no curative standard therapy exists. The primary objective of the Phase 2 trial is to measure tumour responses and duration of response, and to describe any evidence of antitumour activity. The secondary objective is to determine the safety and tolerability of REOLYSIN® when administered in combination with paclitaxel and carboplatin to patients with advanced or metastatic head and neck cancers.
Thursday, June 12, 2008
Oncolytics Biotech Inc. to Present at BIO 2008 International Convention
CALGARY, June 12 - Oncolytics Biotech Inc., announced today that Dr. Brad Thompson, President and CEO of Oncolytics, will participate in two separate presentations at the BIO 2008 International Convention.
Dr. Thompson is scheduled to provide a corporate overview of the Company on Tuesday, June 17th at 3:30 p.m. PT at the BIO Business Forum.
On Wednesday, June 18th at 4:00 p.m. PT, Dr. Thompson is also scheduled to participate as an invited speaker as part of a panel discussion entitled "Canada: Your Global Partner for Cancer Research Innovation."
The Conference, which is expected to draw approximately 20,000 attendees, will be held at the San Diego Convention Center June 17th to June 20th, 2008.
Dr. Thompson is scheduled to provide a corporate overview of the Company on Tuesday, June 17th at 3:30 p.m. PT at the BIO Business Forum.
On Wednesday, June 18th at 4:00 p.m. PT, Dr. Thompson is also scheduled to participate as an invited speaker as part of a panel discussion entitled "Canada: Your Global Partner for Cancer Research Innovation."
The Conference, which is expected to draw approximately 20,000 attendees, will be held at the San Diego Convention Center June 17th to June 20th, 2008.
Tuesday, June 10, 2008
Oncolytics Biotech Inc. Announces Start of Enrolment in Phase 1/2 Ovarian Cancer Clinical Trial with Reolysin
CALGARY, June 10 - Oncolytics Biotech Inc. ("Oncolytics") announced today that patient enrolment has started in a Phase 1/2 clinical trial for patients with metastatic ovarian, peritoneal and fallopian tube cancers using concurrent intravenous (IV) and intraperitoneal (IP) administration of REOLYSIN®, Oncolytics' proprietary formulation of the human reovirus. The National Cancer Institute (NCI), part of the National Institutes of Health, is sponsoring the trial under its Clinical Trials Agreement with Oncolytics, while Oncolytics will provide clinical supplies of REOLYSIN®. The Principal Investigator is Dr. David E. Cohn, Associate Professor, Division of Gynecologic Oncology at The Ohio State University College of Medicine in Columbus, Ohio.
"REOLYSIN® is an exciting agent to investigate in patients with ovarian cancer," said Dr. Cohn. "Targeting a specific alteration commonly present in these tumors will hopefully lead to efficacy with minimal toxicity."
"We are looking forward to working closely with the NCI to examine the effects of using REOLYSIN® with two concurrent methods of administration," said Dr. Brad Thompson, President and CEO of Oncolytics. "Our REOLYSIN® clinical program has now expanded to include ten Phase 1/2 or Phase 2 trials in the U.S. and the U.K. using REOLYSIN® as a monotherapy or in combination with radiation or chemotherapy."
In the Phase 1 portion of the trial, patients will receive a constant dose of IV REOLYSIN® on days 1-5 every 28 days, as well as an escalating dose of IP REOLYSIN® on days 1-2 every 28 days. In the Phase 2 portion of the study, patients will receive a constant dose of IV REOLYSIN® on days 1-5 every 28 days as well as the Maximum Tolerated Dose (MTD) of IP REOLYSIN® from the Phase 1 portion.
The primary objectives of the Phase 1 trial are to determine the safety and tolerability of intravenous and intraperitoneal administration of REOLYSIN®, and the MTD of IP REOLYSIN® when used with a fixed dose of IV REOLYSIN®. The primary objective of the Phase 2 trial is to determine the objective response rate of treatment with IV and IP REOLYSIN® in patients with recurrent, platinum-refractory ovarian, peritoneal and tubal carcinomas. The Phase 1/2 trial is expected to enroll up to 70 patients.
The American Cancer Society estimates that more than 22,000 women will be diagnosed with ovarian cancer in the U.S. in 2008, and more than 15,000 will die from it.
"REOLYSIN® is an exciting agent to investigate in patients with ovarian cancer," said Dr. Cohn. "Targeting a specific alteration commonly present in these tumors will hopefully lead to efficacy with minimal toxicity."
"We are looking forward to working closely with the NCI to examine the effects of using REOLYSIN® with two concurrent methods of administration," said Dr. Brad Thompson, President and CEO of Oncolytics. "Our REOLYSIN® clinical program has now expanded to include ten Phase 1/2 or Phase 2 trials in the U.S. and the U.K. using REOLYSIN® as a monotherapy or in combination with radiation or chemotherapy."
In the Phase 1 portion of the trial, patients will receive a constant dose of IV REOLYSIN® on days 1-5 every 28 days, as well as an escalating dose of IP REOLYSIN® on days 1-2 every 28 days. In the Phase 2 portion of the study, patients will receive a constant dose of IV REOLYSIN® on days 1-5 every 28 days as well as the Maximum Tolerated Dose (MTD) of IP REOLYSIN® from the Phase 1 portion.
The primary objectives of the Phase 1 trial are to determine the safety and tolerability of intravenous and intraperitoneal administration of REOLYSIN®, and the MTD of IP REOLYSIN® when used with a fixed dose of IV REOLYSIN®. The primary objective of the Phase 2 trial is to determine the objective response rate of treatment with IV and IP REOLYSIN® in patients with recurrent, platinum-refractory ovarian, peritoneal and tubal carcinomas. The Phase 1/2 trial is expected to enroll up to 70 patients.
The American Cancer Society estimates that more than 22,000 women will be diagnosed with ovarian cancer in the U.S. in 2008, and more than 15,000 will die from it.
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