Merrimack to Present New Analyses of Phase 3 NAPOLI-1 Data at the ESMO 18th World Congress on Gastrointestinal Cancer

On June 21, 2016 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) reported that it will present new analyses of the Phase 3 NAPOLI-1 data in an oral presentation and poster discussion session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 18th World Congress on Gastrointestinal Cancer, June 29 – July 2, 2016 in Barcelona, Spain (Press release, Merrimack, JUN 21, 2016, View Source [SID:1234513483]). An oral presentation by Dr. Richard Hubner, Consultant Medical Oncologist, The Christie NHS Foundation Trust and investigator on the NAPOLI-1 trial, will compare the effects of ONIVYDE (also known as "nal-IRI") in combination with fluorouracil and leucovorin on quality of life in patients with metastatic pancreatic adenocarcinoma previously treated with gemcitabine-based therapy versus treatment with fluorouracil and leucovorin alone.

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Merrimack will also present an analysis of the NAPOLI-1 safety data across patient subgroups in a poster discussion session and a trials-in-progress poster on a Phase 2 study evaluating ONIVYDE containing regimens as first-line therapy for patients with metastatic pancreatic cancer.

Oral Presentation:

Effects of nal-IRI (MM-398) ± 5-fluorouracil on quality of life (QoL) in NAPOLI-1: A phase 3 study in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) previously treated with gemcitabine-based therapy (Abstract O-004)
Wednesday, June 29, 2016, 5:53 – 6:03 PM CEST
Session: Pancreatic Cancer
Poster Presentation Time: Thursday, June 30, 2016, 11:00 – 11:30 AM and 5:10 – 5:40 PM CEST
CCIB, Exhibit Hall
Poster Sessions:

Safety across subgroups in NAPOLI-1: A phase 3 study of nal-IRI (MM-398) ± 5-fluorouracil and leucovorin (5-FU/LV) versus 5-FU/LV in metastatic pancreatic cancer (mPAC) previously treated with gemcitabine-based therapy (Abstract PD-023)
Session: Pancreatic Cancer
Poster Discussion Time: Thursday, June 30, 2016, 11:00 – 11:30 AM CEST
Poster Presentation Time: Thursday, June 30, 2016, 11:00 – 11:30 AM and 5:10 – 5:40 PM CEST
CCIB, Exhibit Hall
Nanoliposomal irinotecan (nal-IRI)-containing regimens versus nab-paclitaxel plus gemcitabine as first-line therapy in patients with metastatic pancreatic adenocarcinoma (mPAC): A randomized, open-label phase 2 study (Abstract P-287)
Session: Pancreatic Cancer
Poster Presentation Time: Thursday, June 30, 2016, 11:00 – 11:30 AM and 5:10 – 5:40 PM CEST
CCIB, Exhibit Hall

6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On June 21, 2016 Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based and other molecular diagnostic testing services, reported receipt of conditional approval from the New York State Department of Health (NYSDOH) for the Company’s multiple fluorescence in situ hybridization (FISH) tests for detection of amplifications or rearrangements of DNA in a number of hematologic cancers, such as leukemias, lymphomas and myelomas in order to form a diagnosis and/or to evaluate prognosis or remission of disease (Filing, 6-K, Rosetta Genomics, JUN 21, 2016, View Source [SID:1234513484]). NYSDOH approval was granted under the Company’s Molecular Oncology and Cellular Tumor Marker permit.

The laboratory is CLIA certified and CAP accredited, yet New York requires an additional permit for each test from the NYSDOH for them to be offered to patients in the state. The NYSDOH also requires the Company to provide any additional information requested within 60 business days for final approval. With this conditional approval, these assays are now available in all 50 states.

"We are delighted to be able to service clients across the State of New York with a full FISH menu for liquid tumor analysis, thus allowing them to better determine appropriate treatment options for their patients with hematologic cancers," stated Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics.

"In addition to this expanded geographic access, recent managed care contracting initiatives have resulted in covered lives for these tests exceeding 155 million in the U.S. Our recognized expertise in FISH and our growing menu of tests serving the hematology-oncology and pathology markets will help strengthen our position with leading managed care plans as a provider of choice for high-quality FISH testing and should enhance our goal to sign additional participation agreements during the second half of 2016," added Mr. Berlin.

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8-K – Current report

On June 20, 2016 Mateon Therapeutics, Inc. (Nasdaq:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported that it plans to hold an event for investors on Monday, June 27, 2016 at 12:00 pm at the Lotte New York Palace Hotel with Bradley J. Monk, M.D., a recognized leader in ovarian cancer and Director of the Division of Gynecologic Oncology at St. Joseph’s Hospital and Medical Center (Filing, 8-K, OXiGENE, JUN 20, 2016, View Source [SID:1234513458]). To listen to a live version of the audio webcast, with presentations expected to begin at approximately 12:15 pm, please visit the company’s website, www.mateon.com. Under the "Investors & News" tab, select the link to "Events & Presentations." A replay of the webcast will be available at this same location after the conclusion of the live event.

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New Analyses of Data Received from Study GOG-0186I
At the investor event on June 27, new analyses will be presented from a more recent (November 2015) and more mature dataset from the GOG-0186I Study in patients with recurrent ovarian cancer, including analyses to further define the patient population most likely to benefit from treatment with CA4P. Given the preclinical data and the mechanism of action of CA4P, Mateon believes that CA4P is likely to have the greatest effect in larger tumors, and therefore performed additional analyses on data from patients with "measurable disease" and on those with larger tumor volumes.
Results of these analyses are listed below.

Intent-to-Treat Population
The GOG-0186I Study compared the combination of CA4P and bevacizumab (CA4P-treated) to bevacizumab alone (control) in women with recurrent ovarian cancer, enrolling a total of 107 patients. The median overall survival (OS) in the intent-to-treat (ITT) group was 3.2 months longer for the CA4P-treated patients compared to the control patients (25.2 vs. 22.0 months, respectively; HR=0.83, not statistically significant). Data published in the Journal of Clinical Oncology (dataset as of April 2015) showed an improvement in median OS of 2.6 months for CA4P-treated patients.

Patients with Measurable Disease
The GOG-0186I Study included 81 patients (75.7% of study patients) with recurrent ovarian cancer that was deemed "measurable", a pre-specified covariate defined by RECIST criteria, and 26 patients (24.3%) deemed "non-measurable." Measurable disease is generally defined as primary tumor sizes greater than 1 cm in diameter, while non-measurable tumors are generally identified and monitored by increased serum CA-125 antigen levels, ascites, or other clinical signs of disease.

Patients with measurable disease treated with CA4P had a 5.6 month improvement in median OS (26.8 vs. 21.2 months; 22% reduction in the risk of death; HR=0.78, not statistically significant), and a 3.7 month improvement in progression free survival (PFS) (9.8 vs. 6.1 months; HR=0.60, p=0.027) compared to control patients with measurable disease.

Additional analyses were conducted on patients with measurable disease whose tumors were larger than the median baseline tumor size (tumor size ³5.7 cm; n=41). CA4P-treated patients with these tumor sizes experienced a 48% reduction in the risk of death (HR=0.52; p=0.095) and a 6.2 month improvement in median PFS (10.5 vs. 4.3 months; HR=0.55, p=0.071) compared to control patients.

"Overall survival is the gold standard for determining clinical benefit in oncology indications. The most recent analyses from this more mature dataset show an improvement in overall survival for all patients treated with CA4P, greater overall survival for patients whose tumors can be measured, and initial evidence of an even greater survival for patients with tumors which are large and the most difficult to treat," said William D. Schwieterman, M.D., President and Chief Executive Officer of Mateon. "These remarkable outcomes align entirely with our preclinical data and the mechanism-of-action of CA4P, provide us with a deep understanding of where and how best to use CA4P as we move forward, and strongly support the efficacy of combination vascular targeted therapy for the treatment of ovarian and other cancers."

Mateon is planning to study CA4P for the treatment of patients with platinum-resistant ovarian cancer in a double-blind randomized placebo controlled study of CA4P in combination with bevacizumab and physician’s choice chemotherapy (PCC) compared to bevacizumab and PCC (the "FOCUS" study). FOCUS will only enroll patients with measurable disease, and includes pre-specified analyses in its first phase that are designed to confirm the outcomes reported today. If these are confirmed, Mateon will consider expansion of its development program for CA4P from platinum-resistant ovarian cancer to the much larger group of patients with recurrent ovarian cancer.

Varian Medical Systems Launches Proton Therapy Blog

On June 20, 2016 Varian Medical Systems (NYSE: VAR), reported the launch of Spot ON, a company blog about proton therapy for the treatment of cancer (Press release, Varian Medical Systems, JUN 20, 2016, View Source [SID:1234513459]). Targeted at clinicians, physicists and administrators of radiotherapy centers around the world, Spot ON will deliver information about new technology developments, system deployments, research and insights from clinicians.

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The first Spot ON blog entry is from Dr. Carl Rossi, medical director of the Scripps Proton Therapy Center in San Diego, California. Dr. Rossi’s blog is an introduction to adaptive radiotherapy using intensity-modulated proton therapy.

Read the first blog entry here: www.varian.com/proton-therapy/spot-news/introduction-adaptive-radiotherapy-using-impt

"Varian is creating the Spot ON blog to increase the awareness and understanding of proton therapy and the important role it plays in cancer treatment," said Bill Hansen, director of marketing, Particle Therapy Division at Varian.

PharmaCyte Biotech CEO Interviewed Live During Marcum MicroCap Conference

On June 20, 2016 PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that Kenneth L. Waggoner, the Chief Executive Officer of PharmaCyte, was interviewed by Stock News Now (SNN) at the 5th Annual Marcum MicroCap Conference in New York City (Press release, PharmaCyte Biotech, JUN 20, 2016, View Source [SID:1234513462]). The SNNLive video interview can be viewed by clicking on the following link: www.PharmaCyte.com/Media.

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During his interview, Mr. Waggoner describes how PharmaCyte plans to use its live cell encapsulation technology, known as Cell-in-a-Box, for the development of treatments for locally advanced, inoperable pancreatic cancer and for Type 1 and insulin-dependent Type 2 diabetes. Mr. Waggoner also discusses the mechanism of action PharmaCyte uses to treat cancerous tumors and talks about PharmaCyte’s plans to begin a Phase 2b clinical trial in patients with locally advanced, inoperable pancreatic cancer. That trial is planned to start in Q4 2016.

In discussing PharmaCyte’s efforts to develop a treatment for diabetes, Mr. Waggoner talks about the preclinical studies that are being conducted concurrently by several renowned experts in the field of diabetes in various countries around the globe. All of these experts are members of PharmaCyte’s International Diabetes Consortium. Mr. Waggoner also explains that by conducting their studies as part of a consortium, rather than sequentially, the overall treatment development timeline has been shortened considerably. This will allow PharmaCyte to potentially begin a clinical trial in diabetes as early as late 2017.