Emerging Data Support Conducting Additional, Later Stage Studies in Multiple Myeloma

Calgary (Press Release) – Oncolytics Biotech® Inc. ("Oncolytics") (TSX:ONC) (OTCQX:ONCYF) (FRA:ONY) today announced that Dr. D.W. Sborov and colleagues made a poster presentation at the 57th American Society of Hematology (ASH) Annual Meeting. The poster presentation, titled "REOLYSIN^® Combined with Carfilzomib for Treatment of Relapsed Multiple Myeloma Patients," discloses updated findings from a pilot study (NCI-9603) in patients with re­lapsed or refractory multiple myeloma treated using the com­bi­na­tion of car­filz­o­mib and REOLYSIN^®. The ASH Annual Meeting runs from December 5th to 8th in Orlando, FL.

Highlights of the data presented in­clude:

• All seven patients treated at the full clinical dose had a clinical response. Patients treated at the full clinical dose (dose level 1) had a deeper and more prolonged response than those treated at dose level minus 1. Of the 12 total patients treated, 11 had a decrease in dominant monoclonal protein during treatment (used to measure clinical response), including all seven patients treated at the full clinical dose;
• The combination of carfilzomib and REOLYSIN^® produced a significant (p=0.005) increase in caspase-3, a marker associated with apoptotic (programmed) cell death, but to a higher degree in those patients treated at dose level 1; and
• The treatment combination was associated with an increased infiltration of CD8+ T-cells and the significant (p=0.005) upregulation of PD-L1, suggesting that the addition of a PD-1 or PD-L1 inhibitor may further optimize the treatment regimen.

"These findings are compelling as we con­tinue to see a strong clin­i­cal benefit rate in this dif­fi­cult to treat cancer, and clear evi­dence of a dose response, with patients at the higher dosing level seeing im­proved out­comes. We plan on testing higher dosage levels to determine the extent of this im­prove­ment," said Dr. Matt Coffey, Chief Operating Officer of Oncolytics. "We recently announced a second study in multiple myeloma examining REOLYSIN^® together with bor­tez­o­mib, with the goal of identifying the best standard of care com­bi­na­tion to ad­vance into later stage clin­i­cal testing."

The investigators noted that this is the first time a REOLYSIN^®-based com­bi­na­tion has been tested in re­lapsed multiple myeloma patients. A pre­vi­ous single-agent study conducted by the col­lab­o­rators in this patient pop­u­la­tion showed that REOLYSIN^® was well tolerated. The col­lab­o­rators and others were noted to have conducted pre­clin­i­cal in­ves­ti­ga­tions that dem­onstrated that the com­bi­na­tion of REOLYSIN^® and car­filz­omib synergistically in­­creased the killing of multiple myeloma cells. This provided the clin­i­cal rationale for this study.

"Based on these evolving data and input received from key opinion leaders, we believe multiple myeloma to be a compelling registration target," said Dr. Brad Thompson, Pres­i­dent and CEO of Oncolytics. "We intend to discuss the design of a poten­tial registration study with regu­la­tory agencies."

NCI-9603 is a U.S. National Cancer Institute sponsored single-arm, open-label study of in­tra­venously admin­is­tered REOLYSIN^® with dexa­meth­a­sone and car­filz­o­mib to patients with re­lapsed or refractory multiple myeloma. Patients receive treat­ment on days 1, 2, 8, 9, 15 and 16 of a 28-day cycle, to be repeated in the absence of disease pro­gres­sion or unacceptable toxicity. Approximately 12 patients will be enrolled in the study. The pri­mary out­come measures in­clude reovirus replication, safety, and tolerability. Secondary out­come measures in­clude examining objective response, duration of response, clin­i­cal benefit, pro­gres­sion-free survival, and time to pro­gres­sion. Other out­come measures will in­clude immunologic correlative markers.

A copy of the poster will be avail­able on the Oncolytics website at: http://www.oncolyticsbiotech.com/for-investors/presentations.

About Multiple Myeloma

Multiple Myeloma is a cancer of the plasma cells and the second most common hema­to­logical malig­nan­cy. The American Cancer Society esti­mates there will be 26,850 new cases diag­nosed in the United States and 11,240 deaths from the disease in 2015.

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 later-stage, ran­dom­ized human trials in various indi­ca­tions 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 pilot single-arm clin­i­cal trial in multiple myeloma, future trials in this indi­ca­tion, 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.