Oncolytics Biotech Inc. (ONCY)

[onco_investor]

CTRC in SanAntonio Starts Two Phase II Trials

Updated clinicaltrials.gov entry lists two new Phase II clinical trials using Reolysin in combo with chemo.

http://clinicaltrials.gov/ct2/results?term=reovirus

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REO 017 A Study of REOLYSIN® in Combination With Gemcitabine in Patients With Advanced Pancreatic Adenocarcinoma

http://clinicaltrials.gov/ct2/show/NCT00998322?term=reovirus&rank=9

Further study details as provided by Oncolytics Biotech:

Primary Outcome Measures:
Determine the clinical benefit rate (Complete Response (CR) + Partial Response (PR) + Stable Disease (SD))in the study population [ Time Frame: 6-9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
Evaluate the safety and tolerability of the treatment regimen in the study population as measured by adverse events associated with the study treatment, and defined by established criteria. [ Time Frame: Within 30 days of last dose of REOLYSIN ] [ Designated as safety issue: Yes ]

Determine the progression-free survival of this combination in patients with advanced or metastatic pancreatic adenocarcinoma. [ Time Frame: 9-12 months ] [ Designated as safety issue: No ]


Estimated Enrollment: 33
Study Start Date: October 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)

Intervention Details:
Biological: REOLYSIN
1E10 TCID50, 1-hour intravenous infusion on Days 1 and 2 and then Days 8 and 9.
Drug: Gemcitabine
800 mg/m2 60-min infusion on Days 1 and 8.
Detailed Description:
Pancreatic cancer remains one of the most lethal cancers, ranking as the fourth leading cause of cancer death for both men and women. The American Cancer Society estimates that 37,170 men and women (18,830 men and 18,340 women) will be diagnosed with pancreatic cancer and 33,370 men and women will die of pancreatic cancer in 2008.

Activating KRAS mutations are the most frequent genetic abnormalities in pancreatic cancer (occurring in 75% to 95% of patients).

REOLYSIN has been demonstrated to kill a wide variety of cells with mutations along the RAS pathway, including pancreatic cancer cells.

The Phase 2 study is designed to characterize the efficacy and safety of REOLYSIN given intravenously in combination with gemcitabine every 3 weeks in patients with advanced pancreatic cancer.

Response is a primary endpoint of this trial. Tumors will be evaluated by CT scan within 14 days of starting treatment, then at 6 weeks, and then every 6 weeks thereafter.

The safety of the gemcitabine and REOLYSIN combination will be assessed by the evaluation of the type, frequency and severity of adverse events, changes in clinical laboratory tests, immunogenicity and physical examination.

Patients may continue to receive therapy under this protocol, provided he/she has not experienced either progressive disease or unacceptable drug-related toxicity that does not respond to either supportive care or dose reduction.

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REO 021 A Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Squamous Cell Carcinoma of the Lung

http://clinicaltrials.gov/ct2/show/NCT00998192?term=reovirus&rank=6

Further study details as provided by Oncolytics Biotech:


Primary Outcome Measures:
Objective response rate (complete response (CR) + partial response (PR)) of the treatment regimen in the study population [Time Frame: 6 months] [Designated as safety issue: No]

Secondary Outcome Measures:
Evaluate the safety and tolerability of the treatment regimen in the study population as measured by adverse events associated with the study treatment, and defined by established criteria. [ Time Frame: Within 30 days of last dose of REOLYSIN ] [ Designated as safety issue: Yes]

To assess progression-free survival (PFS) for the treatment regimen in the study population. [ Time Frame: 9-12 months ] [ Designated as safety issue: No]

Determine the proportion of patient receiving the treatment who are alive and free of disease progression at 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: No]

To determine overall survival with the treatment regimen in the study population [ Time Frame: 9-12 months ] [ Designated as safety issue: No]


Estimated Enrollment: 55
Study Start Date: October 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)

Intervention Details:
Biological: REOLYSIN
3E10 TCID50 1 hour intravenous infusion, administered on Days 1,2,3,4,and 5 of a 21-day cycle
Drug: Paclitaxel
6 AUC mg/mL min, 30-min intravenous infusion, given on Day 1 of a 21-day cycle
Drug: Carboplatin
200 mg/m2, 3-hour intravenous infusion, given on Day 1 of a 21-day cycle

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Both trials are classified as actively recruiting as of today and both trials are sponsored by the CTRC in SanAntonio with Oncolytics providing the Reolysin.

So now with these 2 new trials we have 9 active Phase II trials:

KRAS+ Screened NSCLC (IV combo) - REO 016 at Ohio State Univ - (Interim data due next month?)
http://clinicaltrials.gov/ct2/show/NCT00861627?term=reovirus&rank=1

Platimun Refractory Ovarian (Monotherapy IV and IP) - NCI Sponsored Trial OSU-07022 at Ohio State Univ
http://clinicaltrials.gov/ct2/show/NCT00602277?term=reovirus&rank=2 and
http://www.cancer.gov/clinicaltrials/OSU-07022

Metastatic Melanoma (Monotherapy- IV) - NCI Sponsored Trial Enrolling at 7 Locations in the Mayo Clinic Cancer Centers trial network
http://clinicaltrials.gov/ct2/show/NCT00651157?term=reovirus&rank=4

Recurrent Malignant Glioma - REO 007 Monotherapy - Target end date moved to March 2010 for this long trial
http://clinicaltrials.gov/ct2/show/NCT00528684?term=reovirus&rank=5

Platinum Refractory Head and Neck Cancer - REO 015 Combo with Carboplatin and Paclitaxel - Waiting for Interim and Final Results (next month?)
http://clinicaltrials.gov/ct2/show/NCT00753038?term=reovirus&rank=7

Metastatic Melanoma - REO 020 Combo with Carboplatin and Paclitaxel - Just started enrolling a few months ago
http://clinicaltrials.gov/ct2/show/NCT00984464?term=reovirus&rank=8
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Bone and Soft Tissue Sarcomas REO 014 (Has completed enrollment now awaiting final results.... Rumored to proceed to Phase II in combination with chemo or maybe an adaptive Phase II/III?
http://clinicaltrials.gov/ct2/show/NCT00503295?term=reovirus&rank=3

IMO lots to look forward to these next few months...

onco_investor