Oncolytics Biotech Inc. (ONCY)

[onco_investor]

15th World Conference on Lung Cancer Oct27th

Looks like there will be additional details released at the Annual World Conference on Lung Cancer. It has been noted that most patients in these studies were Stage IV

10/01/2013 13:15:00

Oncolytics Biotech Inc. Collaborators to Present Positive Clinical Trial Data at the 15th Annual World Conference on Lung Cancer

CALGARY, Oct. 1, 2013 /CNW/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC) (NASDAQ:ONCY) today announced that abstracts detailing results from two Phase II studies examining the use of REOLYSIN® in combination with carboplatin and paclitaxel in patients with non-small cell lung cancer (NSCLC) with Kras or EGFR-activated tumors (REO 016) and in patients with squamous cell carcinoma of the lung (REO 021), are now available on the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer website at http://wclc.iaslc.org. The conference is being held from October 27th to 30th, 2013 in Sydney, Australia.

The first abstract, titled "Final Results of a Phase 2 Trial of the Oncolytic Virus REOLYSIN in Metastatic NSCLC Patients with a Ras-activated Pathway," indicated that patients received reovirus (3 x 1010 TCID50) intravenously daily on days one to five, in combination with paclitaxel at initial doses of paclitaxel 175 mg/m2 and carboplatin AUC 5, on day one of each 21-day cycle. Overall, 37 patients received 209 cycles (per patient median four, range one to 18). Grade 3-4 toxicities included febrile neutropenia (two patients), grade 3 diarrhea (two patients), grade 3 anemia (seven patients), fatigue in 6 patients (five grade 3, one grade 4), nausea/vomiting (two patients), electrolyte abnormalities, and single grade 3 episodes of arthralgia and thrombocytopenia. Molecular tumor demographics included: 20 Kras, 3 EGFR and 4 BRAF mutations, and 10 with EGFR amplifications only. Response evaluation for 36 evaluable patients showed 11 partial responses (PR) (30%) (EGFR amplified, five; BRAF two; Kras, three; EGFR mutated, one), 21 stable disease (SD), and four progressive disease (PD). Of the 36 evaluable patients with sufficient follow up to date, progression free survival (PFS) at six months is 36% and one-year survival, 53%.

"The response and clinical benefit rates reported are consistent with the interim data our collaborators reported in late 2012," said Dr. Brad Thompson , President and CEO of Oncolytics. "The six-month progression-free survival and one-year survival data is very encouraging. In the literature, it has been reported that treatment with various chemotherapy combinations alone averaged one-year survival rates of 33% in patients with advanced non-small cell lung cancer1. Stage IV patients similar to the ones we treated in this study see overall one-year survival rates of approximately 16%."

The second abstract, titled "A Phase 2 Study of Intravenous Administration of REOLYSIN (Reovirus Type 3 Dearing) in Combination with Paclitaxel (P) and Carboplatin (C) in Patients with Squamous Cell Carcinoma of the Lung," reflects information submitted to the IASLC conference in June 2013, prior to the Company's subsequent announcement of updated data from the REO 021 study in the press release dated September 9, 2013.

About Lung Cancer
The American Cancer Society estimates that in 2013, approximately 228,190 new cases of lung cancer will be diagnosed. Between 85% and 90% of all lung cancers are classified as non-small cell lung cancer (NSCLC); squamous cell carcinomas account for 25-30% of all lung cancers. Lung cancer is by far the leading cause of cancer death among both men and women. There will be an estimated 159,480 deaths from lung cancer in the United States in 2013, accounting for around 27% of all cancer deaths. Lung cancer is the leading cause of cancer death, with more people dying each year of lung cancer than from colon, breast, and prostate cancers combined. For more information about SCC lung cancer, please go to www.cancer.org.

References
1 As reported in The New England Journal of Medicine (N Engl J Med, Vol. 346, No. 2, January 10, 2002) by Schiller, et al, a total of 1,207 patients with advanced non-small-cell lung cancer were randomly assigned to a reference regimen of cisplatin and paclitaxel or to one of three experimental regimens: cisplatin and gemcitabine, cisplatin and docetaxel, or carboplatin and paclitaxel. The response rate for all 1,155 eligible patients was 19 percent, with a median survival of 7.9 months (95 percent confidence interval, 7.3 to 8.5), a 1-year survival rate of 33 percent (95 percent confidence interval, 30 to 36 percent).

2 As reported in Clinical Epidemiology (2011:3 139-148), Cetin, et al, using data from the Surveillance, Epidemiology and End Results (SEER) Program, stratified 51,749 incident stage IV NSCLC patients (1988-2003 with follow-up through 2006) by major histologic subtype. Overall one-year survival (95% confidence interval) in stage IV non-small cell lung cancer patients who survived at least 31 days (n=44,172) was 15.9%.

About Oncolytics Biotech Inc.
Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. Oncolytics' clinical program includes a variety of human trials including a Phase III trial in head and neck cancers using REOLYSIN®, its proprietary formulation of the human reovirus. For further information about Oncolytics, please visit: www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the Company's expectations related to the U.S. Phase II non-small cell lung cancer trial, the U.S. Phase II squamous cell carcinoma lung cancer trial, future trials in these indications, and the Company's belief as to the potential of REOLYSIN as a cancer therapeutic, involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN as a cancer treatment, the tolerability of REOLYSIN outside a controlled test, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize REOLYSIN, uncertainties related to the research, development and manufacturing of pharmaceuticals, changes in technology, general changes to the economic environment and uncertainties related to the regulatory process. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors should consider statements that include the words "believes", "expects", "anticipates", "intends", "estimates", "plans", "projects", "should", or other expressions that are predictions of or indicate future events or trends, to be uncertain and forward-looking. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

SOURCE Oncolytics Biotech Inc.

Abstracts from the Conference Website

P1.11-026 | Final Results of a Phase 2 Trial of the Oncolytic Virus Reovirus Serotype 3-Dearing Strain (REOLYSIN®) in Metastatic NSCLC Patients with a Ras-activated Pathway.

Authors: Miguel Villalona-Calero1, Elaine Lam1, Weiqiang Zhao1, Gregory Otterson1, Deepa Subramaniam2, Bo Chao1, Matthew Timmons1, Larry Schaaf1, George M Gill3, Matt Coffey3
1The Ohio State University, Columbus, OH/UNITED STATES OF AMERICA, 2Georgetown University, Washington/UNITED STATES OF AMERICA, 3Oncolytics Biotech INC, Alberta/CANADA

Background:
Reovirus is a naturally occurring virus which preferentially infects and causes oncolysis in tumor cells with a Ras-activated pathway. In preclinical studies, reovirus induces cell cycle arrest, acting synergistically with standard cytotoxic agents. We have hypothesized that patients with EGFR-mutated, EGFR-amplified, BRAF or Kras-mutated NSCLC should all have a common downstream activated Ras pathway and should be susceptible to treatment with reovirus.

Methods:
We conducted a Fleming, single-arm, phase II study to evaluate safety and the objective response rate (primary end-points), as well as 6-month progression-free and 1 year survival (secondary end-points) of metastatic NSCLC patients treated with reovirus in combination with paclitaxel/carboplatin (P/C). Eligible patients had ECOG PS 0-2, adequate organ function, no prior chemotherapy for metastatic disease, and tumors with the specified above genotype, as per CLIA certified laboratory testing. Prior adjuvant chemotherapy, or erlotinib/gefitinib for pts with EGFR-mutant tumors was permitted.

Patients received Reovirus (3 x 1010 TCID50) intravenously daily on days 1-5, in combination with P/C at initial doses of P 200 mg/m2 and C AUC 6, on day 1 of each 21-day cycle. Due to exacerbation of prior colitis and febrile neutropenia (1 each) in the first two pts, doses were subsequently reduced to P 175 mg/m m2 and C AUC 5.

Results:
Overall, 37 patients received 209 cycles (per pt median 4, range 1 to 18). Grade 3-4 toxicity included febrile neutropenia (3 pts), G3 diarrhea (2 pts), G3 anemia (8 pts), fatigue in 6 pts (5 G3, 1 G4), nausea/vomiting and thrombocytopenia (2 pts each), electrolyte abnormalities, and single G3 episodes of arthralgia and transaminitis.

Molecular tumor demographics included: 20 Kras (2 G12A, 9 G12C, 1 G12D, 1 G12R, 1 G12S, 3 G12V, 1 G13C, 1 G13R, 1 G12C/V double mutant), 3 EGFR exon 19, 4 BRAF V600E mutations, and 10 EGFR amplified only.

Response evaluation showed 11 RECIST partial responses (30%) (EGFR amp 5, BRAF 2, Kras 3, EGFR mut 1), 21 SD, and 4 PD. PFS (by CT and PET) at 6 months for 36 patients with enough follow up to date is 36%, with PET results influencing switching to second line therapy in several patients with SD by CT. Sixteen patients received 6 or more cycles. One year survival was 53%.

Conclusion:
Reovirus can be administered safely in combination with P/C and patient selection by Ras-activated pathway is feasible in the clinical setting. Overall clinical efficacy is encouraging.

Randomized evaluation is planned.




P1.11-048 | A Phase 2 Study of Intravenous Administration of REOLYSIN® (Reovirus Type 3 Dearing) in Combination with Paclitaxel (P) and Carboplatin (C) in Patients with Squamous Cell Carcinoma of the Lung

Authors: Alain C. Mita1, Athanassios Argiris2, Matt Coffey3, George M. Gill3, Monica Mita1
1Cedars-Sinai Medical Center, Los Angeles, CA/UNITED STATES OF AMERICA, 2University of Texas Health Science Center at San Antonio, San Antonio, TX/UNITED STATES OF AMERICA, 3Oncolytics Biotech Inc., Calgary/CANADA

Background:
Squamous Cell Carcinoma of the lung (SCCLung) has long been recognized as very difficult to treat, with few agents showing effectiveness. Because the combination of P/C and REOLYSIN was shown to be active in 2 trials in SCC of the head and neck, we elected to test this regimen in this Phase 2 trial in SCCLung.

Methods:
We conducted a single-arm, open-label phase II study to determine (primary) the Objective Response Rate (ORR) and(secondary) the 6-month Progression-free Survival (PFS) and the Overall Survival (OS) of patients with metastatic or recurrent squamous cell carcinoma of the lung, treated with REOLYSIN in combination with P/C.

The study had a two-stage design, with 19 patients in the first stage. The trial would be terminated if 3/19 or fewer patients obtained an objective response. If the trial continued to the second stage, a total of up to 36 patients would be studied. The primary endpoint would be met if patients in both stages had an ORR of at least 35%.

Eligible patients had ECOG PS 0–2, adequate organ function, and no prior systemic chemotherapy for their metastatic or recurrent disease. Prior adjuvant chemotherapy or chemo-XRT for treatment of primary disease was allowed, provided it had been = 6 months since the last chemotherapy. Treatment dosages were: paclitaxel 200 mg/m2 IV over 3 hours; carboplatin at a dose of AUC 6 mg/mL minute calculated using standard formula(s)and REOLYSIN 3x1010 TCID50IV over 1 hour daily for 5 days.

Results:
32 patients entered the study and received at least one dose of study drug. The patient population included 20 males and 12 females, median age was 62 years (range: 37 to 80 years) and all were Caucasian including one Hispanic patient.

Of the 32 entered, 25 patients received more than one Cycle of therapy and a total of 125 cycles were administered in that group (per patient mean=5, median=6, range 2-12). The 7 non-evaluable patients received 1 cycle or less.

Of the 25 evaluable patients who received more than one cycle, 12 (48%) had a PR, 10(40%) had stable disease (SD), and 3 (12%) had progressive disease (PD) for overall disease control (CR + PR + SD) in 22/25 (88%). Of 21 patients with >6 months follow-up, 7 (33.3%) have PFS of at least 6 months.

The most common adverse events (AEs) seen were those expected with P/C---neutropenia 17 (9=Gr 3-4) and thrombocytopenia 15 (5=Gr 3-4) and those expected with REOLYSIN---fever 6 (1=Gr 3) and fatigue 11 (4=Gr 3). The AE profile of P/C therapy did not appear to be significantly altered by the addition of REOLYSIN.

The only serious adverse event reported as unexpected and related to study therapy was reversible Gr 2 elevation of creatinine (and increased BUN) which occurred 3 weeks after Cycle 8 in a 65-year-old woman.

Conclusion:
Combination therapy with paclitaxel/carboplatin/REOLYSIN was well-tolerated in patients with recurrent/metastatic SCClung and the response results justify further studies.