On March 10, 2017 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported data from the ongoing Phase Ib/II clinical trial of sulfatinib in patients with advanced neuroendocrine tumors ("NET") at the 14th Annual Conference of the European Neuroendocrine Tumor Society ("ENETS"), held in Barcelona, Spain from March 8 to 10, 2017 (Press release, Hutchison China MediTech, MAR 10, 2017, http://www.chi-med.com/sulfatinib-net-ph2-results-at-enets-2017/ [SID1234518078]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Sulfatinib is an oral, novel angio-immunokinase inhibitor that selectively targets vascular endothelial growth factor receptor ("VEGFR"), fibroblast growth factor receptor ("FGFR") and colony-stimulating factor-1 receptor ("CSF-1R"), three key tyrosine kinase receptors involved in tumor angiogenesis and immune evasion. Five other sulfatinib clinical trials are underway in China and the U.S., including two Phase III studies in NET patients (SANET-p and SANET-ep), one Phase II study in thyroid cancer patients and one Phase II study in biliary tract cancer patients.

The most recent results of the study were presented in detail as follows:

Presentation Type: Oral Presentation, Presidential Abstract – Plenary Meeting Room

Title: An Open-Label Phase Ib/II Study of Sulfatinib in Patients with Advanced Neuroendocrine Tumors (NCT02267967)

Presented by: Dr. JianMing Xu

Session: Session 2B: Medical Therapies and Goals

Date & Time: Thursday, March 9, 2017, 11:10 AM CET



Presentation summary

The current Phase Ib/II trial is an open-label, single-arm Phase II study to assess the efficacy and safety of sulfatinib monotherapy in patients with advanced grade 1 or 2 advanced NET. 81 patients (41 pancreatic NET and 40 extra-pancreatic NET) were enrolled between November 2014 and January 2016, in seven clinical centers across China. The majority of patients had grade 2 disease (79%) and had failed previous systemic treatments (65%). As of January 20, 2017, 13 patients had confirmed partial response ("PR") and 61 patients had stable disease ("SD") corresponding to an overall objective response rate ("ORR") of 16.0% (13/81), with 17.1% (7/41) in pancreatic NET and 15.0% (6/40) in extra-pancreatic NET, and an overall disease control rate ("DCR") of 91.4%. Median overall progression-free survival ("PFS") has not been reached, but is estimated to be 16.6 months (95% CI: 13.4, 19.4) with longer median PFS in pancreatic NET estimated at 19.4 months and shorter median PFS in extra-pancreatic NET estimated at 13.4 months. Importantly, there were 12 patients who had progressed after treatment with targeted therapies (e.g. Sutent and Afinitor) and all benefited from sulfatinib treatment (3 PRs and 9 SDs). Sulfatinib was well tolerated with Grade ≥3 adverse events (AEs), with >5% incidence, regardless of causality of hypertension (31%), proteinuria (14%), hyperuricemia (10%), hypertriglyceridemia (9%), diarrhea (7%) and ALT increase (6%). Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02267967.

Based on the promising Phase I and Phase II efficacy data and tolerability in patients with advanced NETs, two randomized Phase III trials are ongoing.

The presentation is available at www.chi-med.com/news/. Further information about ENETS is available at enetsconference.org.





About NET
NET arises from neuroendocrine cells and develop predominantly in the digestive or respiratory tracts but can also occur in many areas of the body. Diagnosis of NET is difficult due to the small tumor size and diverse origination with patients showing varied or no symptoms. There were approximately 20,000 new cases of NET and a cumulative prevalence of approximately 148,000 cases in the U.S. in 2016[1].

NETs can be classified according to tumor origin, as pancreatic NET representing less than 10% of the total NET patients, and extra-pancreatic NET comprising all other non-pancreatic NETs including lung, lymph and gastrointestinal tract NETs. To date, treatment options for NET patients are limited; sunitinib and everolimus are the only two approved targeted-therapies for NET, sunitinib for pancreatic NET and everolimus for NET of pancreatic, gastrointestinal or lung origin, while there is no such a choice for broad spectrum NET patients.



About Sulfatinib
Sulfatinib is an oral, novel angio-immunokinase inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFR, FGFR and CSF-1R, three key tyrosine kinase receptors involved in tumor angiogenesis and immune evasion. Inhibition of the VEGFR signaling pathway can act to stop angiogenesis, the growth of the vasculature around the tumor, and thereby starve the tumor of the nutrients and oxygen it needs to grow rapidly. Aberrant activation of the FGFR signaling pathway, which can be increased by anti-VEGFR therapy treatment, is shown to be associated with cancer progression by promoting tumor growth, angiogenesis and formation of the myeloid derived suppressor cells. Inhibition of the CSF-1R signaling pathway blocks the activation of tumor-associated macrophages, which are involved in suppressing immune responses against tumors.

In addition to the current Phase Ib/II NET trial, five sulfatinib clinical trials are underway in China and the U.S., including two Phase III studies in NET patients (SANET-p and SANET-ep), one Phase II study in thyroid cancer patients and one Phase II study in biliary tract cancer patients.

The SANET-p trial is a randomized, double-blind, placebo-controlled, multi-center, Phase III pivotal registration trial to treat about 190 pathologically low or intermediate grade pancreatic NET patients in China whose disease has progressed, locally advanced or distant metastasized and for whom there is no effective therapy. The primary endpoint is PFS, with secondary endpoints including ORR, DCR, duration of response ("DoR"), time to response and overall survival ("OS"). Additional details of the SANET-p study may be found at clinicaltrials.gov, using identifier NCT02589821. The SANET-ep trial is similar to the SANET-p trial and is targeted at treating about 270 non-pancreatic NET patients in China. Additional details of the SANET-ep study may be found at clinicaltrials.gov, using identifier NCT02588170.

Chi-Med is conducting an open-label Phase II clinical trial to evaluate the efficacy and safety of sulfatinib in about 50 patients with locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer or medullary thyroid cancer in China. The primary endpoint is ORR, with secondary endpoints including safety and tolerability, DCR, time to response and PFS. Additional details of this study may be found at clinicaltrials.gov, using identifier NCT02614495.

Chi-Med is also conducting an open-label Phase II clinical trial to evaluate the efficacy and safety of sulfatinib in about 32 patients with advanced or metastatic biliary tract cancer who failed one prior systemic therapy in China. The primary endpoint is PFS at 16 weeks, with secondary endpoints including the ORR, DCR, DoR, PFS, OS and safety. Additional details of this study may be found at clinicaltrials.gov, using identifier NCT02966821.

On March 10, 2017 Spotlight Innovation Inc. (OTCQB: STLT) reported that its subsidiary Celtic Biotech has begun Part 2 of its Phase I dose escalation safety study, Crotoxin in Patients with Advanced Cancer using an Intravenous Route of Administration (Press release, Spotlight Innovation, MAR 10, 2017, View Source [SID1234518077]). ImmunoClin Ltd., a company specializing in clinical development, is the contract research organization (CRO) overseeing the study conduct.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Part 2 of the Phase I study uses a revised protocol designed to determine whether faster dose escalation can be attained in a shortened time frame without increased risk to patients. The trial is being conducted at the Department of Medical Oncology at Pitié-Salpêtrière Hospital in Paris under the direction of Principal Investigator Maria A. Gil-Delgado, MD, PhD. Dr. Gil-Delgado is a member of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). Noted French oncologist David Khayat, MD, PhD, FASCO, a Board Member of ASCO (Free ASCO Whitepaper), is serving as Principal Scientific Advisor.

John Krohn, Spotlight Innovation’s President and Chief Operating Officer, said, "Commencement of Part 2 of this study is a significant step in our cancer drug development program. Crotoxin is an important new potential treatment option for patients with advanced solid tumors, and we are pleased with our progress in the clinical trial process."

Oncology is one of four focus areas within Spotlight Innovation’s research and development pipeline; the others are chronic pain, Zika virus infection and spinal muscular atrophy (SMA).

On March 10, 2017 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company) reported its financial results and operational highlights for the year ended December 31, 2016 (Filing, Q4/Annual, Oncolytics Biotech, 2016, MAR 10, 2017, View Source [SID1234518074]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"It was a year of change for Oncolytics, highlighted by additional clinical data that saw our understanding of REOLYSIN’s mechanism of action evolve and grow," said Dr. Matt Coffey, President and CEO of Oncolytics. "Through this process, and with the help of our expanding senior team, we thoughtfully and deliberately put in place a plan that initially contemplates combinations with chemotherapy for late-stage clinical development, but will expand to include targeted immunotherapies over the longer term as we look to leverage the role of the immune system in patient treatment. In the coming months we will specifically define our first registration pathway. In the year ahead we expect data readouts from as many as five sponsored, randomized Phase 2 studies, including one in advanced or metastatic breast cancer."

Selected Highlights

Since January 1, 2016, selected highlights announced by the Company include:

Clinical Results

· An abstract submitted to the American Association of Cancer Research Annual Meeting by Canadian Cancer Trials Group ("CCTG") at Queen’s University in Kingston, Ontario covering results from IND 213, an open-label, randomized, non-blinded Phase 2 study to assess the therapeutic combination of intravenously-administered REOLYSIN given in combination with paclitaxel versus paclitaxel alone in patients with advanced or metastatic breast cancer;
· A poster presentation by Dr. Kevin Kelly at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on the Phase 1b Study of REOLYSIN with Bortezomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma, with preliminary data suggesting evidence of activity and that the treatment combination was well tolerated;
· Additional data from a randomized, CCTG-sponsored Phase 2 clinical study of REOLYSIN in non-small cell lung cancer (IND 211), which showed: a statistically significant improvement (p=0.0201) in progression free survival (PFS) for female patients with adenocarcinoma in the test arm versus the control arm, a strong trend to improved overall survival (OS) for female patients with adenocarcinoma in the test arm versus the control arm;
· Preliminary data from a randomized, CCTG-sponsored Phase 2 clinical study of REOLYSIN in advanced or metastatic colorectal cancer (IND 210), following an abstract for the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, which showed a statistically significant improvement in objective response rates in female patients (female patients in the test arm had an overall response rate (ORR) of 63.2% (n=19) versus 23.8% (n=21) in the control arm (p=0.0054)), and a trend to improvement in median OS in female patients (female patients in the test arm had median OS of 19.3 months (n=19) versus 14.5 months (n=21) in the control arm);
· Updated results from a randomized Phase 2 clinical trial of its lead product, REOLYSIN, in combination with carboplatin and paclitaxel in patients with pancreatic cancer (NCI-8601), where an intent-to-treat analysis of overall survival on patients with confirmed treatment regimes, as assessed by the percentage of patients surviving for two years, showed a doubling of patients surviving two years; 20% on the test arm versus 9% on the control arm;
· Treatment of the first patients in a Phase 1b study of pembrolizumab (KEYTRUDA) in combination with REOLYSIN and chemotherapy in patients with advanced pancreatic adenocarcinoma, the Company’s first trial examining REOLYSIN in combination with a checkpoint inhibitor;


Corporate

· The appointment of Oncolytics co-founder and long-serving senior executive Matt Coffey PhD, MBA, as President and CEO;
· The appointment of Andres Gutierrez, MD, PhD, with more than 25 years of senior clinical development expertise designing and implementing both early- and late-stage oncology clinical studies, to the role of Chief Medical Officer;
· Formation of a Science and Technology Committee charged with supporting REOLYSIN’s further development in the context of the broader oncology space with an ultimate focus on reaching a commercial endpoint; and


Financial

· At December 31, 2016, the Company reported $14.1 million in cash, cash equivalents and short-term investments. At March 9, 2017, the Company had approximately $11.3 million in cash, cash equivalents and short-term investments.



ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

2016 2015
As at December 31, $ $
Assets
Current assets
Cash and cash equivalents 12,034,282 24,016,275
Short-term investments 2,088,800 2,060,977
Accounts receivable 54,406 340,059
Prepaid expenses 260,841 506,669
Total current assets 14,438,329 26,923,980

Non-current assets
Property and equipment 319,955 459,818
Total non-current assets 319,955 459,818

Total assets 14,758,284 27,383,798

Liabilities And Shareholders’ Equity
Current Liabilities
Accounts payable and accrued liabilities 4,068,664 2,709,492
Total current liabilities 4,068,664 2,709,492

Shareholders’ equity
Share capital
Authorized: unlimited
Issued:
December 31, 2016 – 121,258,222
December 31, 2015 – 118,151,622 262,321,825 261,324,692
Contributed surplus 26,643,044 26,277,966
Accumulated other comprehensive income 554,060 760,978
Accumulated deficit (278,829,309) (263,689,330)
Total shareholders’ equity 10,689,620 24,674,306
Total liabilities and equity 14,758,284 27,383,798






ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS

2016 2015 2014
For the years ending December 31, $ $ $

Expenses
Research and development 9,770,007 8,601,864 13,824,252
Operating 5,524,500 5,315,837 4,998,694
Loss before the following (15,294,507) (13,917,701) (18,822,946)
Interest 163,902 197,859 210,390
Loss before income taxes (15,130,605) (13,719,842) (18,612,556)
Income tax recovery (expense) (9,374) (3,153) (6,779)
Net loss (15,139,979) (13,722,995) (18,619,335)
Other comprehensive income items that may be reclassified to net loss
Translation adjustment (206,918) 480,935 200,345

Net comprehensive loss (15,346,897) (13,242,060) (18,418,990)
Basic and diluted loss per common share (0.13) (0.12) (0.21)

Weighted average number of shares (basic and diluted) 119,880,200 112,613,845 87,869,149






ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY


Share Capital
$
Warrants
$
Contributed
Surplus
$
Accumulated
Other
Comprehensive
Income
$
Accumulated
Deficit
$
Total
$
As at December 31, 2013 228,612,564 376,892 24,491,212 79,698 (231,347,000) 22,213,366

Net loss and other comprehensive income — — — 200,345 (18,619,335) (18,418,990)
Issued, pursuant to Share Purchase Agreement 8,861,652 — — — — 8,861,652
Issued, pursuant to "At the Market" Agreement 1,468,668 — — — — 1,468,668
Expired warrants — (376,892) 376,892 — — —
Share based compensation — — 980,325 — — 980,325
Share issue costs (1,285,828) — — — — (1,285,828)
As at December 31, 2014 237,657,056 — 25,848,429 280,043 (249,966,335) 13,819,193

Net loss and other comprehensive income — — — 480,935 (13,722,995) (13,242,060)
Issued, pursuant to Share Purchase Agreement 4,371,687 — — — — 4,371,687
Issued, pursuant to "At the Market" Agreement 20,049,693 — — — — 20,049,693
Share based compensation — — 429,537 — — 429,537
Share issue costs (753,744) — — — — (753,744)
As at December 31, 2015 261,324,692 — 26,277,966 760,978 (263,689,330) 24,674,306

Net loss and other comprehensive income — — — (206,918) (15,139,979) (15,346,897)
Issued, pursuant to incentive share award plan 41,000 — (41,000) — — —
Issued, pursuant to "At the Market" Agreement 1,456,296 — — — — 1,456,296
Share based compensation — — 406,078 — — 406,078
Share issue costs (500,163) — — — — (500,163)
As at December 31, 2016 262,321,825 — 26,643,044 554,060 (278,829,309) 10,689,620





ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS

2016 2015 2014
For the years ending December 31, $ $ $

Operating Activities
Net loss for the year (15,139,979) (13,722,995) (18,619,335)
Amortization – property and equipment 162,233 180,411 163,501
Share based compensation 406,078 429,537 980,325
Unrealized foreign exchange (gain) loss (139,810) (816,319) 242,542
Net change in non-cash working capital 2,233,865 (1,105,464) (2,443,988)
Cash used in operating activities (12,477,613) (15,034,830) (19,676,955)

Investing Activities
Acquisition of property and equipment (23,527) (108,268) (152,750)
Redemption (purchase) of short-term investments (27,823) (29,292) (30,041)
Cash used in investing activities (51,350) (137,560) (182,791)

Financing Activities
Proceeds from Share Purchase Agreement — 4,305,396 7,830,409
Proceeds from "At the Market" equity distribution agreement 956,133 19,362,240 1,214,083
Cash provided by financing activities 956,133 23,667,636 9,044,492
(Decrease) increase in cash (11,572,830) 8,495,246 (10,815,254)
Cash and cash equivalents, beginning of year 24,016,275 14,152,825 25,220,328
Impact of foreign exchange on cash and cash equivalents (409,163) 1,368,204 (252,249)
Cash and cash equivalents, end of year 12,034,282 24,016,275 14,152,825



To view the Company’s Fiscal 2016 Consolidated Financial Statements, related Notes to the Consolidated Financial Statements, and Management’s Discussion and Analysis, please see the Company’s annual filings, which will be available under the Company’s profile at www.sedar.com and on Oncolytics’ website at View Source

On March 10, 2017 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported an upcoming poster presentation at the 2017 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place from April 1-5, 2017 in Washington D.C. Dr. Ana Tari Ashizawa, Director of Research at Bio-Path, will present preclinical data of BP1002 (Liposomal Bcl2 antisense), the Company’s second drug candidate, for the treatment of aggressive non-Hodgkin’s lymphoma (Filing, 8-K, Bio-Path Holdings, MAR 10, 2017, View Source [SID1234518073]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Details for the poster presentation are as follows:

Date: Wednesday, April 5, 2017
Presentation Time: 8:00 am – 12:00 pm Eastern Time
Location: Walter E. Washington Convention Center
Session: Gene and Vector Based Therapy, Section 3
Abstract: 5091
Title: "Activity of Bcl-2 antisense therapeutic in aggressive non-Hodgkin’s lymphoma" (Link to abstract)