On June 23, 2016 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported nine presentations of rolapitant data at the 2016 MASCC/ISOO Annual Meeting on Supportive Care in Cancer, June 23 to 25, 2016, in Adelaide, Australia (Press release, TESARO, JUN 23, 2016, View Source [SID:1234513532]).

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"Delayed chemotherapy-induced nausea and vomiting can be a debilitating side effect of chemotherapy. At this year’s MASCC/ISOO Annual Meeting, which is the premier global event for supportive care in cancer, we are pleased that data will be presented that demonstrate the activity of rolapitant in patients at high risk for CINV, including those who are receiving cisplatin- and carboplatin-based chemotherapy for gynecologic and lung cancers," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "With our Marketing Authorisation Application (MAA) for oral rolapitant under review by the European Medicines Agency (EMA) and our New Drug Application (NDA) for intravenous rolapitant under review by the U.S. FDA, we look forward to globalizing our mission of improving the lives of people bravely facing cancer."

Please visit TESARO at Booth #3 for information about VARUBI (rolapitant) and our pipeline.

Presentation Details:

Rolapitant for control of chemotherapy-induced nausea and vomiting (CINV) in patients with gynecologic cancer
Abstract: MASCC-0318, Poster Presentation, Thursday, June 23, 2016

Rolapitant for the prevention of nausea in patients receiving moderately or highly emetogenic chemotherapy
Abstract: MASCC-0322, Poster Presentation, Thursday, June 23, 2016

Rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients aged <65 versus ≥65 years
Abstract: MASCC-0432, Poster Presentation, Thursday, June 23, 2016

Single ascending dose pharmacokinetics of rolapitant administered intravenously at supratherapeutic doses in healthy volunteers
Abstract: MASCC-0489, Poster Presentation, Thursday, June 23, 2016

Effects of rolapitant administered intravenously on the pharmacokinetics of cooperstown cocktail (midazolam [CYP3A4], omeprazole [CYP2C19], warfarin [CYP2C9], caffeine [CYP1A2], and dextromethorphan [CYP2D6]) in healthy volunteers
Abstract: MASCC-0492, Poster Presentation, Thursday, June 23, 2016

Effects of rolapitant administered intravenously on the pharmacokinetics of digoxin (P-gp) and sulfasalazine (BCRP) in healthy volunteers
Abstract: MASCC-0494, Poster Presentation, Thursday, June 23, 2016

A single-dose bioequivalence study of rolapitant following oral and intravenous administration in healthy volunteers
Abstract: MASCC-0485, Oral Poster Presentation, Friday, June 24, 2016 from 2:00 PM to 3:30 PM

Rolapitant for control of chemotherapy-induced nausea and vomiting (CINV) in patients with lung cancer
Abstract: MASCC-0321, Oral Proffered Presentation, Hall M, Saturday, June 25, 2016 from 11:00 AM to 12:30 PM

Rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with breast cancer
Abstract: MASCC-0316, Oral Proffered Presentation, Hall M, Saturday, June 25, 2016 from 11:00 AM to 12:30 PM

About VARUBI (Rolapitant)
VARUBI is a substance P/neurokinin-1 (NK-1) receptor antagonist indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. VARUBI is contraindicated in patients receiving thioridazine, a CYP2D6 substrate. The inhibitory effect of a single dose of VARUBI on CYP2D6 lasts at least seven days and may last longer. Avoid use of pimozide; monitor for adverse events if concomitant use with other CYP2D6 substrates with a narrow therapeutic index cannot be avoided. Please see full the U.S. prescribing information, including additional important safety information, available at www.varubirx.com.

An intravenous formulation of rolapitant is currently under review by the FDA, with a target action date under the Prescription Drug User Fee Act (PDUFA) of January 11, 2017. An MAA for oral rolapitant is currently under review by the EMA. TESARO licensed exclusive rights for the development, manufacture, commercialization, and distribution of VARUBI (rolapitant) from OPKO Health, Inc.

On June 23, 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 the release of 5 video presentations that captured PharmaCyte’s medical and scientific discussion with oncologists interested in participating in PharmaCyte’s Phase 2b clinical trial in advanced, inoperable pancreatic cancer (Press release, PharmaCyte Biotech, JUN 23, 2016, View Source [SID:1234513531]). The discussion session was by invitation only during the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago.

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Portions of the session were videotaped, and the videos can be viewed at: www.PharmaCyte.com/Media

Commenting on the medical and scientific discussion, the company’s Chief Executive Officer, Kenneth L. Waggoner said, "On behalf of PharmaCyte, I would like to express our sincere appreciation to all who participated in this event, particularly those who traveled from Europe and Thailand to make presentations. Special thanks to those oncologists who sacrificed their time at the ASCO (Free ASCO Whitepaper) annual meeting to play such a major role. The discussion period led by Dr. Hidalgo was informative and stimulating. We believe it will prove to be of great value to PharmaCyte as we move forward with our preparations for the Phase 2b trial in patients with locally advanced pancreatic cancer."

In addition to senior management from PharmaCyte, participants in the meeting included Dr. Walter H. Günzburg, PharmaCyte’s Chief Scientific Officer, Dr. Brian Salmons, a member of PharmaCyte’s Medical and Scientific Advisory Board, Dr. Matthias Löhr, from the Karolinska Institute in Stockholm, Sweden and the Chairman of PharmaCyte’s Medical and Scientific Advisory Board, and Dr. Manuel Hidalgo from the Beth Israel Deaconess Medical Center in Boston and a member of PharmaCyte’s Medical and Scientific Advisory Board. Joining PharmaCyte at the discussion were Dr. Stephen Gately and a team from Translational Drug Development (TD2), Dr. Ronald L. Korn from Imaging Endpoints, and, most importantly, a number of leading clinical oncologists from cancer institutions in the United States and Europe.

The meeting began with an introductory slide presentation by Mr. Waggoner. This was followed by presentations from Dr. Günzburg and Dr. Salmons that covered the development of the Cell-in-a-Box technology and the properties of the capsules produced using PharmaCyte’s platform technology. Dr. Löhr, who served as the Principal Investigator for the previous 2 clinical trials using PharmaCyte’s pancreatic cancer therapy, presented the results of the previous Phase 1/2 and Phase 2 clinical trials. Dr. Hidalgo then covered the elements of the design of PharmaCyte’s upcoming Phase 2b clinical trial. Following these formal presentations, Dr. Hidalgo facilitated an hour-long discussion in which the invited oncologists discussed the proposed Phase 2b trial and ways to improve its design.

On June 23, 2016 Mylan N.V. (NASDAQ, TASE: MYL), one of the world’s leading pharmaceutical companies, reported a €1 million donation to the Princess Máxima Center for Pediatric Oncology, a new national cancer center currently being built in Utrecht, the Netherlands (Press release, Mylan, JUN 23, 2016, View Source [SID:1234513522]).

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The donation from Mylan will support the Princess Máxima Center in its mission of treating and curing children with cancer by enhancing research efforts and supporting patients and their families while at the center for treatment.

Mylan Executive Chairman Robert J. Coury commented, "Mylan’s mission is to set new standards in healthcare and provide access to high quality medicine to patients around the world; however, our mission starts with the communities in which we operate, and we have had the privilege to serve customers and patients in the Netherlands for more than 17 years. The mission of the Princess Máxima Center is closely aligned with Mylan’s and I would like to commend Prof. Pieters for his vision and leadership in raising the standard of care for cancer in the Netherlands and ensuring children with cancer have equal access to the best care available."

Mylan CEO Heather Bresch added, "Every two days a child dies from cancer in the Netherlands and one in four children does not survive their fight with this disease. Through our commitment to providing access to oncology medications to patients around the world, we strive to do our part to help treat and cure cancer, and we believe our partnership with The Princess Máxima Center is just one of the ways we can go beyond medicine to deliver better health for a better world."

Professor Pieters, member of the board of the Princess Máxima Center commented, "We are grateful to Mylan for their generous support of the Princess Máxima Center, which is focused on treating children with cancer using the best possible methods, while also preventing the development of negative side effects in young patients, both now and over the long term. By bringing together expertise in care and research in the Princess Máxima Center, the Netherlands will become a leader in the field of pediatric oncology both in Europe and globally. It is a position that will help us fulfill our ambition: to cure every child with cancer. I am delighted that our collaboration with Mylan will further support the care we provide and our continued research."

Matean Niël, Mylan country manager in the Netherlands added: "I am thrilled to see Mylan supporting a cause in the Netherlands that puts people and patients first. Mylan’s support of the Princess Máxima Center creates a lot of pride among our hundreds of employees based in Bunschoten, Weesp and Zwolle. This initiative reflects our local commitment to institutional care in the Netherlands."

On June 23, 2016 ArQule, Inc. (Nasdaq:ARQL) reported that preliminary data from the ongoing phase 2 portion of a phase 1/2 trial in intrahepatic cholangiocarcinoma (iCCA) with our proprietary fibroblast growth factor receptor (FGFR) inhibitor, ARQ 087, will be presented on June 30, 2016 at the ESMO (Free ESMO Whitepaper) 18th World Congress on Gastrointestinal Cancer in Barcelona, Spain (Press release, ArQule, JUN 23, 2016, View Source [SID:1234513506]). This is a biomarker driven trial designed to enroll at least 20 patients in iCCA with FGFR2 genetic alterations. The company has been granted orphan drug designation by the U.S. Food and Drug Administration and European Medicine’s Agency for ARQ 087 in this indication.

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Presentation Details
Abstract Number: 340 (PD #19)
Poster Title: ARQ 087, an Oral Pan-Fibroblast Growth Factor Receptor (FGFR) Inhibitor, in Patients with Advanced and/or Metastatic Intrahepatic Cholangiocarcinoma (iCCA)
Poster Discussion Time: June 30, 2016 from 11:00 a.m. to 11:30 a.m. CEST
Poster Presentation Time: June 30, 2016 from 5:10 p.m. to 5:40 p.m. CEST
Location: Exhibit Hall

About Intrahepatic Cholangiocarcinoma

Cholangiocarcinoma (CCA) is the most common biliary malignancy and the second most common hepatic malignancy after hepatocellular carcinoma (HCC)1. Depending on the anatomic location, CCA is classified as intrahepatic (iCCA), perihilar (pCCA), and extrahepatic (eCCA). iCCA originates from the intrahepatic biliary ductal system and forms an intrahepatic mass. The average age adjusted incidence rate for iCCA is approximately one in 100,000 per year in the United States and Europe2,3.

About FGFR and ARQ 087

ARQ 087 is a multi-kinase inhibitor designed to preferentially inhibit the fibroblast growth factor receptor ("FGFR") family with demonstrated efficacy in FGFR2 genetic alterations. The FGFR pathway is disrupted in several ways in human cancer, thus providing numerous therapeutic targets for an inhibitor of this pathway. ARQ 087 has demonstrated in vivo inhibition of tumor growth and downstream signaling in tumors whose growth is driven by FGFR targets.

Signals of single agent activity with this drug were observed in phase 1a testing. Phase 1b expansion cohorts with ARQ 087 include patients with cholangiocarcinoma and adrenocortical tumors, as well as those with FGFR translocations, amplifications and mutations. Clinical development of ARQ 087 has advanced into phase 2 for intrahepatic cholangiocarcinoma (iCCA) following the observation of two confirmed responses in this patient population in the phase 1 portion of the program.