Oncolytics Biotech Inc. Announces 2008 First Quarter Results

Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) today announced its financial results and highlights for the three month period ended March 31, 2008.

“We are currently enrolling or recruiting patients in a total of nine clinical trials, four exploring the use of REOLYSIN® as a monotherapy, and five exploring the use of REOLYSIN® in combination with a variety of chemotherapies, immune modulation and radiotherapy, ” said Dr. Brad Thompson, President and CEO of Oncolytics. “In 2008, we expect to report interim or final results on a number of our ongoing clinical trials. We are rapidly moving toward the point where we can expect to make pivotal clinical trial decisions about REOLYSIN®. It is an exciting time for Oncolytics and our shareholders.”

First Quarter Highlights

Significant Clinical Advances

• Met the criteria to expand to full enrolment of 52 patients in our U.S. Phase II sarcoma trial after the third patient treated in the trial experienced stable disease by RECIST criteria for more than six months.

• In early April, our collaborators presented positive interim results from our U.K. combination REOLYSIN® and paclitaxel/carboplatin trial at the British Society of Gene Therapy conference in Edinburgh. Three head and neck patients evaluated to date have had excellent clinical and radiological responses without appreciable toxicity.

• The U.S. National Cancer Institute filed a protocol with the U.S. FDA to conduct a Phase I/II ovarian, peritoneal and fallopian tube cancer trial. The trial is currently recruiting patients.

• Research characterizing immune system responses to REOLYSIN® in our U.K. Phase I systemic administration trial was published in the March 6 issue of Gene Therapy.

Preclinical Advances

• Two papers were published in Clinical Cancer Research covering preclinical work with reovirus in combination with radiation, and reovirus administration following cyclophosphamide.
• In April, two presentations were made 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.
• In April, a paper covering preclinical work demonstrating that reovirus can kill melanoma cell lines and freshly resected tumour was published in Gene Therapy.

Intellectual Property

• Two Canadian patents and one U.S. patent were secured in the quarter.

To read the full release click here.

New Article Published in the Journal of Immunology on Reovirus Activation of Dendritic Cells

Oncolytics Biotech announced the publication of the first study that shows that the reovirus directly activates human dendritic cells, and that reovirus-activated dendritic cells stimulate innate killing by natural killer cells and T cells. This suggests a new potential role for T cells in oncolytic virus-induced local tumor cell death.

Read the press release here or below.

Oncolytics Biotech Inc. Announces Journal of Immunology Publication on Reovirus Activation of Dendritic Cells

Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) announced today that Prof. Alan Melcher and his research group at St. James’s University Hospital in Leeds, U.K. published the results of their work with reovirus in the May 1, 2008 online issue of The Journal of Immunology. The paper is entitled “Reovirus Activates Human Dendritic Cells to Promote Innate Antitumor Immunity.”

The researchers studied the ability of reovirus to activate human dendritic cells (DC), key regulators of both innate and adaptive immune responses. The data demonstrated that reovirus directly activates human DC, which in turn stimulate innate killing of cancer cells by natural killer (NK) and T cells, suggesting a novel potential role for T cells in oncolytic virus-induced local tumor cell death. Combined with the virus’s ability to directly kill cancer cells, the researchers concluded that reovirus recognition by DC may enhance the efficacy of reovirus as a therapeutic agent.

“This research provides additional insight into how reovirus interacts with the immune system, and expands our understanding of its multiple roles in the killing of cancer cells,” said Dr. Matt Coffey, Chief Scientific Officer of Oncolytics.

To read the journal abstract click here.

ClinicalTrials.gov Updated: Now Recruiting Viral Therapy in Treating Patients With Metastatic Melanoma

Viral Therapy in Treating Patients With Metastatic Melanoma

RATIONALE: Viral therapy may be able to kill tumor cells without damaging normal cells.
PURPOSE: This phase II trial is studying the side effects and how well viral therapy works in treating patients with metastatic melanoma.

OBJECTIVES:

Primary

• 
  To assess the antitumor effect of wild-type reovirus (Reolysin®), in terms of tumor response rate and clinical benefit rate (i.e., partial response and complete response), in patients with metastatic melanoma.
• 
  To assess the toxicity profile of Reolysin® in these patients.
  

Secondary

• 
  To assess the progression-free survival and overall survival of these patients.
• 
  To assess viral replication in metastatic melanoma deposits after intravenous administration of Reolysin®.
• 
  To assess the impact of pre-existing anti-reoviral immunity (as represented by p38 expression in pretreatment tumor specimens) on the efficacy and toxicity of Reolysin®.
• 
  To measure the effect of Reolysin® on the immune system, in terms of dendritic cell activation, T-cell activation, presence of Treg cells in tumor specimens, and the frequency of T cells, B cells, NK cells, and peptide specific cytotoxic T lymphocytes reactive against melanoma differentiation antigen peptides (gp100, MART-1, and tyrosinase).
• 
  To assess the induction of melanoma specific immune response, in terms of the presence of melanoma differentiation antigens (gp100, MART-1, and tyrosinase) in tumor specimens.

OUTLINE:

This is a multicenter study.
Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Tumor tissue samples are collected at baseline and at 1 week after initiation of treatment for correlative laboratory studies. Tissue samples are analyzed for p38/MAPK activation status by IHC; reoviral replication in metastatic deposits by electron microscopy; and immunologic parameters by IHC. Blood samples are collected at baseline, at 4 weeks after initiation of treatment, and then every 2 months thereafter. Blood samples are analyzed for immunologic parameters by tetramer and ELISPOT technology and for neutralizing antibodies against reovirus.

After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 5 years

Article: Cedars-Sinai Medical Center opens patient trial of virus that attacks brain cancer cells

LOS ANGELES (April 15, 2008) – A common, naturally occurring virus that attacks cancer cells but appears to be harmless to normal cells is being studied as a possible treatment for malignant, highly aggressive and deadly brain tumors called gliomas. Researchers at Cedars-Sinai Medical Center are among a few in the United States evaluating this experimental therapy.

Read more here.

For more information on the glioma study, which is offered through the Johnnie L. Cochran, Jr. Brain Tumor Center, patients may contact Cedars-Sinai Medical Center at 1-800-CEDARS-1 or at www.csmc.edu under “Clinical Trials.”

Oncolytics Biotech Inc. Announces Gene Therapy Publication on Reovirus Treatment for Melanoma

Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) announced today that Prof. Alan Melcher and his research group at St. James's University Hospital in Leeds, U.K. published the results of their work in the April 10 online issue of Gene Therapy. The paper is entitled "Inflammatory Tumour Cell Killing by Oncolytic Reovirus for the Treatment of Melanoma."

The investigators showed that reovirus effectively kills and replicates in both human melanoma cell lines and freshly resected tumour. They demonstrated that reovirus melanoma killing is more potent than, and distinct from, chemotherapy or radiotherapy-induced cell death. They concluded that reovirus is suitable for clinical testing in melanoma.

"Our ongoing preclinical work indicates that reovirus has a number of mechanisms by which it kills melanoma cell lines and tumours," said Dr. Brad Thompson, President and CEO of Oncolytics. "This most recent work provides additional support to our upcoming Phase II melanoma clinical trial with the U.S. National Cancer Institute."

Oncolytics Biotech Inc. Collaborators Present Reovirus Research for Multiple Myeloma at AACR Annual Meeting

Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) announced that an oral presentation by Dr. Chandini Thirukkumaran of the Tom Baker Cancer Centre, Calgary, entitled "Targeting Multiple Myeloma with Oncolytic Viral Therapy" was presented today at the American Association for Cancer Research (AACR) Annual Meeting. The meeting is being held in San Diego, California from April 12-16, 2008.

The presentation covered preclinical work using reovirus as a purging agent during autologous (harvested from the patient themselves) hematopoietic stem cell transplants for multiple myeloma. The results demonstrated that up to 70% of multiple myeloma cell lines tested showed reovirus sensitivity and reovirus induced cell death mediated through apoptosis.

The investigators concluded that this preclinical data supports initiating a Phase I purging trial using reovirus against multiple myeloma.

Oncolytics Biotech Inc. Collaborators Present Reovirus Research for Pediatric Sarcomas at AACR Annual Meeting

Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) announced that a poster presentation by Dr. Anders Kolb of the Nemours Center for Childhood Cancer Research entitled “Radiation in Combination with Reolysin for Pediatric Sarcomas” was presented today at the American Association for Cancer Research (AACR) Annual Meeting. The meeting is being held in San Diego, California from April 12-16, 2008.

“The combination of REOLYSIN® with radiation is certainly favourable,” said Dr. Kolb. “Statistically significant improvements in event-free survival are seen in mice treated with the combination when compared to either therapy alone.”

The poster covers preclinical work using reovirus in combination with radiation in mice implanted with pediatric rhabdomyosarcoma and Ewing’s sarcoma tumours. The results demonstrated that the combination of reovirus and radiation significantly enhanced efficacy compared to either treatment alone in terms of tumour regression and event-free survival.

“We are very pleased to be working with investigators such as Dr. Kolb,” said Dr. Matt Coffey, Chief Scientific Officer of Oncolytics. “The work completed by Dr. Kolb and his team supports our ongoing efforts in our human trials with REOLYSIN®.”

The poster will be available on the Oncolytics website today at www.oncolyticsbiotech.com

Click here to go to the poster.

Oncolytics Biotech Inc. Completes Dose Escalation in Combination Reolysin/Paclitaxel and Carboplatin Trial

Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) has completed patient enrolment in the dose escalation portion of its U.K. clinical trial to evaluate the anti-tumour effects of systemic administration of REOLYSIN® in combination with paclitaxel and carboplatin in patients with advanced cancers including head and neck, melanoma, lung and ovarian.

"The preliminary results from this combination trial are very encouraging," said Dr. Brad Thompson, President and CEO of Oncolytics. "This study was the first to begin examining the use of REOLYSIN® with drug combinations that are used in first or second line therapy.

The principal investigators are Dr. Kevin Harrington of The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, and Dr. Geoff Hall of St. James's Hospital in Leeds, U.K.

The trial (REO 011) has two components. The first is an open-label, dose-escalating, non-randomized study of REOLYSIN® given intravenously with paclitaxel and carboplatin every three weeks. Standard dosages of paclitaxel and carboplatin were delivered to patients with escalating dosages of REOLYSIN® intravenously. The second component of the trial includes the enrolment of a further 12 patients at the maximum dosage of REOLYSIN® in combination with a standard dosage of paclitaxel and carboplatin.

Eligible patients include those who have been diagnosed with advanced or metastatic solid tumours such as head and neck, melanoma, lung and ovarian cancers that are refractory (have not responded) to standard therapy or for which no curative standard therapy exists. The primary objective of the trial is to determine the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicity (DLT), recommended dose and dosing schedule and safety profile of REOLYSIN® when administered in combination with paclitaxel and carboplatin. Secondary objectives include the evaluation of immune response to the drug combination, the body's response to the drug combination compared to chemotherapy alone and any evidence of anti-tumour activity.

In the U.K. and the U.S., approximately 350,000 people are diagnosed annually with head & neck, melanoma, lung and ovarian cancers.

Viral Therapy in Treating Patients With Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer That Did Not Respond

This study is currently recruiting participants.

RATIONALE: Viral therapy may be able to kill tumor cells without damaging normal cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of viral therapy in treating patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer that did not respond to platinum chemotherapy.

OBJECTIVES:

Primary

• To determine the safety and tolerability of intravenous (IV) and intraperitoneal (IP) administration of wild-type reovirus (REOLYSIN®). (Phase I)
• To determine the maximum tolerated dose of IP REOLYSIN® when used with a fixed dose of IV REOLYSIN®. (Phase I)
• To determine the objective response rate (complete response and partial response per RECIST criteria) of treatment with IV and IP REOLYSIN® in patients with recurrent, platinum-refractory ovarian epithelial, peritoneal, or fallopian tube carcinoma. (Phase II)
  

Secondary

• To identify viral replication in tumor following IV reovirus.
• To identify anti-reovirus antibodies in patients being treated with IV and IP REOLYSIN® therapy.
• To identify viral replication in the abdominal washings of patients undergoing IV and IP REOLYSIN® therapy.
• To correlate response to therapy with Ras oncogene status.
• To evaluate double-stranded RNA-activated protein kinase activity in tumors.
• To correlate molecular predictors of response to REOLYSIN® therapy.
  

OUTLINE: This is a phase I, dose-escalation study of intraperitoneal (IP) wild-type reovirus when administered with fixed dose IV wild-type reovirus followed by a phase II study.

Phase I: Patients receive wild-type reovirus IV over 60 minutes on days 1-5 in course 1, followed by insertion of an IP access port. Beginning in course 2, patients receive wild-type reovirus IV over 60 minutes on days 1-5 and wild-type reovirus IP over 10 minutes on days 1 and 2*. Treatment with IV and IP wild-type reovirus repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Phase II: Patients undergo IP access port insertion before beginning treatment. Patients receive wild-type reovirus IV over 60 minutes on days 1-5 and IP (at the maximum tolerated dose determined in phase I) over 10 minutes on days 1 and 2*. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients receive IP wild-type reovirus on days 2 and 3 in course 3.

Prior to each IP wild-type reovirus administration, normal saline is administered through the IP catheter and withdrawn for correlative studies in courses 2 and 3 (phase I) or courses 1 and 2 (phase II). Patients also undergo a CT-guided percutaneous tumor biopsy on day 2 of course 3 (phase I or II). Samples are analyzed by immunohistochemistry, RT-PCR, and electron microscopy for the relevant molecular effects of wild-type reovirus on tumor and normal tissue.

After completion of study treatment, patients are followed for up to 12 weeks.

PROJECTED ACCRUAL: A total of 70 patients (up to 30 for phase I and 40 for phase II) will be accrued for this study.

For more information go here.

Oncolytics Biotech Inc. Reports Positive Interim Results of U.K. Combination REOLYSIN® and Carboplatin/Paclitaxel Trial

CALGARY, AB, --- April 9, 2008 - Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC, NASDAQ:ONCY) today announced positive interim results from its U.K. combination REOLYSIN® and carboplatin/paclitaxel trial. Dr. Kevin Harrington of The Institute of Cancer Research, London, and the principal investigator for the trial, presented the results today at The 5th Annual Conference of the British Society for Gene Therapy (BSGT) in Edinburgh, Scotland.

Four of the first eight patients treated in the study to date have a diagnosis of carcinoma of the head and neck. All three head and neck patients evaluated to date have had excellent clinical and radiological responses without appreciable toxicity. Preliminary assessment after recruitment of the first two cohorts has suggested that patients with head and neck carcinomas may represent a group of patients in whom the combination of carboplatin/paclitaxel and REOLYSIN® is active.

“These early results in head and neck patients are remarkable, considering the prognosis for refractory patients is generally poor,” said Dr. Karl Mettinger, Chief Medical Officer for Oncolytics.

In the first cohort, the patient with head and neck cancer received 8 cycles of treatment (the maximum allowed) and achieved a clinical complete response. In the second cohort, the two patients with head and neck cancers with widespread disseminated disease have each received six cycles of treatment to date and both have achieved significant partial responses. Two of the three patients, including the patient with the clinical complete response, had previously received cisplatin/5-FU treatment and all three had previously received radiotherapy.

More information about this clinical trial, including CT scans from selected patients enrolled on the trial, can be found on the Oncolytics website at www.oncolyticsbiotech.com.

The primary objective of the trial is to determine the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicity (DLT), recommended dose and dosing schedule and safety profile of REOLYSIN® when administered in combination with paclitaxel and carboplatin. Secondary objectives include the evaluation of immune response to the drug combination, the body’s response to the drug combination compared to chemotherapy alone and any evidence of anti-tumour activity.

The principal investigators are Dr. Kevin Harrington of The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, and Dr. Geoff Hall of St. James’s Hospital in Leeds, U.K.

Oncolytics Form 6-K Annual Report Published

Click here to see the entire report.