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TMCNet:  Pluristem Announces Senior Executive Appointments; Merc; Enters Collaborations with Amgen, Incyte and Pfizer to Evaluate MK-3475

[February 05, 2014]

Pluristem Announces Senior Executive Appointments; Merc; Enters Collaborations with Amgen, Incyte and Pfizer to Evaluate MK-3475

(BioMed Reports Via Acquire Media NewsEdge) Below is a look at some of the headlines for companies that made news in the healthcare sector on February 5, 2014.

Pluristem Therapeutics, Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapies, announced the appointments of two of its senior executives. These executive appointments support the Company’s growth and opportunities both on the clinical development front and with its big-pharma corporate partnerships. This comes at a time when Pluristem is advancing its cell therapies for numerous indications through global clinical trials.


Yaky Yanay has been promoted to President and Chief Operating Officer. Mr. Yanay joined Pluristem in 2006, serving as the Company’s Chief Financial Officer in charge of financial strategy. Since March of 2012, Mr. Yanay has also served as the Company’s Executive Vice President. Mr. Yanay is a member of the board of directors of Israel Advanced Technologies Industries, the largest umbrella organization in Israel for companies, organizations, and individuals in the high tech and life science sectors. Mr. Yanay holds a bachelor's degree with honors in business administration and accounting, and he is a Certified Public Accountant in Israel.Boaz Gur-Lavie has been appointed to the position of Chief Financial Officer and Secretary. Mr. Gur-Lavie recently joined Pluristem, serving as the Company’s Vice President of Finance. Prior to joining Pluristem, Mr. Gur-Lavie was CFO of Abbott Informatics Division, responsible for different Abbott informatics brands and STARLIMS, a global software organization which helps laboratories optimize data accessibility, integrity, defensibility and long-term value. Before that, he served as VP Finance of STARLIMS, a software company traded on the NASDAQ and Tel-Aviv stock exchange prior to being acquired by Abbott. Mr. Gur-Lavie previously served as assistant controller at ECI. Prior to which he served as a senior manager on the ERS team of Deloitte Israel. He has also served as a lecturer at Ben Gurion University. Mr. Gur-Lavie holds a master’s degree in finance and a bachelor’s degree in economy and accounting from the University of Ben-Gurion. He is a Certified Public Accountant in Israel.“Both Yaky and Boaz bring tremendous value to the Company and these appointments are very well-deserved. Their proven leadership skills, their strategic choices and their implementation of operational goals will take Pluristem to the next level of achievement," stated Zami Aberman, Chairman and CEO of Pluristem. “Our entire scientific, manufacturing, and operational team has done a phenomenal job of advancing our cell therapies to serve unmet medical needs.”Yaky Yanay, Pluristem’s President and COO commented, “In the last year we were focused on building our manufacturing capabilities and our technology’s competitive advantages. Now, following the strengthening of our executive and management team, our Company is ready and set to meet the significant opportunities ahead for the benefit of our shareholders, business partners and our employees.” =======================Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today it has signed three separate clinical collaboration agreements, through subsidiaries, with Amgen Inc., Incyte Corporation and Pfizer Inc. to evaluate novel combination regimens with MK-3475, Merck’s investigational anti-PD-1 immunotherapy. The financial terms of the agreements were not disclosed.“Merck clinical scientists intend to explore the potential of our PD-1 inhibitor across a wide range of cancers, both as monotherapy and in combination,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “These new collaborations with Amgen, Incyte and Pfizer underscore our shared determination to evaluate treatment regimens with the potential to provide meaningful benefits to patients suffering from cancer.”Planned investigations include: Pfizer and Merck will evaluate in Phase I/II clinical studies the safety and efficacy of MK-3475 in combination with Pfizer’s small molecule kinase inhibitor axitinib (INLYTA®) in patients with renal cell carcinoma, and separately MK-3475 plus PF-05082566 (PF-2566), an investigational immuno-oncology agent that targets the human 4-1BB receptor, in multiple cancer types.Incyte and Merck will collaborate on a randomized, double-blind placebo controlled Phase I/II study to evaluate the safety and efficacy of a regimen combining MK-3475 with Incyte’s investigational immunotherapy agent, INCB24360, an indoleamine 2, 3-dioxygenase (IDO) inhibitor, in patients with previously treated metastatic and recurrent NSCLC, among other advanced or metastatic cancers.Amgen and Merck will evaluate MK-3475 in combination with Amgen’s investigational oncolytic immunotherapy talimogene laherparepvec in a Phase I/II study in patients with previously untreated advanced melanoma.Separately, Merck announced it will start a new Phase I “signal finding” study to evaluate the safety and efficacy of MK-3475 monotherapy in 20 different PD-L1-positive solid tumor types that have not been studied previously (clinical trials identifier: NCT02054806).About MK-3475Many tumors are able to evade the immune system through a mechanism that exploits the PD-1 inhibitory checkpoint protein. MK-3475 is an investigational, highly selective anti-PD-1 immunotherapy designed to restore the natural ability of the immune system to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein. By blocking PD-1, MK-3475 enables activation of the immune system’s T-cells that target cancer, essentially by releasing a brake on the immune system.MK-3475 is being studied in 13 clinical trials estimated to enroll more than 4,000 patients across more than 30 types of cancer including: bladder, colorectal, gastric, head and neck, melanoma, non-small and small cell lung, renal, pancreatic, prostate, triple negative and estrogen-receptor positive HER 2-negative breast, gynecologic, and hematological malignancies, among others. Additional trials, both as monotherapy and in combination with other cancer therapies, are planned. For information on Merck’s clinical trials please visit http://www.merck.com/clinical-trials/.Breakthrough Therapy designation for MK-3475 in advanced melanoma was granted by the U.S. Food and Drug Administration in April 2013. Merck announced in January the initiation of a rolling submission of a Biologics License Application for MK-3475 in advanced melanoma in the U.S. The company expects to complete the submission in the first half of 2014.

Also Wednesday: Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today announced that Michael R. Minogue, Chairman, President and Chief Executive Officer will present at the Leerink Global Healthcare Conference 2014, February 12 at 1:00 p.m. EST. Advaxis, Inc. (Nasdaq:ADXS), a biotechnology company developing the next generation of cancer immunotherapies, announced it has expanded its relationship by entering into a master clinical trial agreement with GRU Cancer Center to conduct four Phase 1/2 clinical trials. Aratana Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company focused on the licensing or acquisition, development and commercialization of innovative biopharmaceutical products for cats, dogs and other companion animals,today announced additions to its Board of Directors. Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR)today reported financial results for the three months ended December 31, 2013.Bioanalytical Systems, Inc. (Nasdaq:BASI)will release financial results for the first quarter of fiscal 2014 ended December 31, 2013 at approximately 8:30 a.m. EST on Thursday, February 13, 2014. Biodel Inc. (Nasdaq:BIOD) will issue its first quarter fiscal year 2014 financial results on February 6, 2014. Following the release of the company's financial results, Biodel's senior management will host a conference call to discuss the results and provide an update on the company's progress.BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced that Jean-Jacques Bienaimé, Chief Executive Officer of BioMarin, will host a conference call and webcast on Monday, March 3, at 8:00 a.m. ET to discuss fourth quarter and full year 2013 financial results.Burcon NutraScience Corporation, (TSX:BU) (Nasdaq:BUR) a leader in functional and renewable plant protein ingredients, has received a notice of allowance from the United States Patent and Trademark Office for an important and commercially strategic CLARISOY™ patent application. CannaVest Corp. (OTC:CANV), the world's leading cannabis-based investment company spearheading the development of cannabidiol (CBD)-rich hemp oils and other industry-related products and services, is pleased to announce that its subsidiary, PhytoSPHERE Systems, has increased its industrial hemp oil production over 1500% for the 2014 season. Cara Therapeutics, Inc. (Nasdaq:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain by selectively targeting kappa opioid receptors, today announced the closing of its initial public offering of 5,750,000 shares of common stock at a public offering price of $11.00 per share. Cellular Biomedicine Group Inc. (OTCQB:CBMG), a biomedicine firm engaged in the development of new treatments for degenerative and cancerous diseases, today announced that Dr. Wei (William) Cao, Chief Executive Officer, will be presenting at the 9th annual New York Stem Cell Summit. Celsus Therapeutics Plc (Nasdaq:CLTX), an emerging growth, development-stage biotech company, announced today the closing of its previously announced public offering of 1,533,333 American Depository Shares ("ADSs") on the NASDAQ Capital Market at a price of $6.00 per ADS. SmallCapVoice.com, Inc. announced today that a new audio interview with Fresh Start Private Management, Inc. (OTCQB:CEYY), a leader in alcohol treatment and rehabilitation programs, is now available. Galectin Therapeutics Inc. (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced that the Company will present at the 16th Annual BIO CEO & Investor Conference, to be held February 10-11, 2014, at the Waldorf Astoria Hotel in New York City. Global Links Corp. (OTC:GLCO), the owner of Hemp Life Today, LLC, today announced the launch of an online marketing program to its rapidly growing website, HempLifeToday.com™, called the Marketplace Merchant Program™.Health Insurance Innovations, Inc. (Nasdaq:HIIQ), a leading developer, administrator and private exchange for affordable, cloud-based individual health insurance plans and ancillary products, today announced the launch of its Health Insurance Plan Cost Estimator.Innovus Pharmaceuticals, Inc., (OTCBB:INNV)today announced that Dr. Bassam Damaj, Ph.D., Chief Executive Officer and President, will present at the 16th Annual BIO CEO & Investor Conference, to be held at the Waldorf-Astoria Hotel in New York February 10-11, 2014. Insulet Corporation (NASDAQ: PODD), the leader in tubeless insulin pump technology with its OmniPod® Insulin Management System, and Cassidy Turley, a leading commercial real estate services provider, today announced the relocation of its corporate headquarters from Bedford, MA to a 90,000 square-foot facility at 600 Technology Park Drive in Billerica, MA. LDR Holding Corporation (Nasdaq:LDRH), a global medical device company focused on designing and commercializing novel and proprietary surgical technologies for the treatment of patients suffering from spine disorders, announced today that it will report financial results for the fourth quarter ended December 31, 2013 after the market close on Thursday, February 27, 2014. MacroGenics, Inc. (Nasdaq:MGNX), a clinical-stage biopharmaceutical company focused on discovering and identifying innovative monoclonal antibody-based therapeutics for the treatment of cancer and autoimmune diseases, today announced that Servier, France's largest privately-held pharmaceutical company, has exercised its exclusive option to develop and commercialize MGD006, a DART-based product candidate developed by MacroGenics. Medical Action Industries Inc. (Nasdaq:MDCI), a leading supplier of medical and surgical disposable products, today reported financial results for the third quarter ended December 31, 2013, including net sales of $110.0 million and gross profit of $20.2 million or 18.4% of net sales. Medical Marijuana Inc. (OTC Pink:MJNA) would like to inform shareholders and the general public that HempMedsPX™ – a corporate portfolio company of Medical Marijuana Inc. and the exclusive master distributor and contracted marketing company for CannaVest Corp. and Medical Marijuana Inc. – is actively expanding global sales based on CannaVest Corp. (OTC:CANV)'s subsidiary, PhytoSPHERE Systems' 1,500% increase in production capability for industrial hemp-based cannabidiol (CBD) oil.NanoString Technologies, Inc. (Nasdaq:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced that the company will release 2013 fourth quarter financial results after the close of trading on Wednesday, February 26, 2014. NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, is pleased to announce executive leadership changes that will foster the Company's continued evolution into an increasingly profitable, $1 Billion Start-up™.Nymox Pharmaceutical Corporation (Nasdaq:NYMX) is pleased to announce the appointment of Andre Monette as Chief Financial Officer of the Company. OraSure Technologies, Inc. (Nasdaq:OSUR), a market leader in oral fluid diagnostics, today announced its consolidated financial results for the full-year and fourth quarter of 2013.PDL BioPharma, Inc. (NASDAQ: PDLI) announced today that it intends to offer, subject to market and other conditions, $250 million aggregate principal amount of new convertible senior notes due February 1, 2018 (notes) under the Company's shelf registration statement filed with the U.S. Securities and Exchange Commission (SEC) on June 21, 2013. Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of RNA interference (RNAi) therapeutics, today announced that Dr. Mark Murray, President and CEO of Tekmira, will provide a corporate overview on Tuesday, February 11, 2014 at 8:30 am ET at the 16 Annual BIO CEO & Investor Conference at the Waldorf Astoria Hotel in New York City.TESARO, Inc. (Nasdaq:TSRO)announced today that Lonnie Moulder, CEO of TESARO, and Mary Lynne Hedley, Ph.D., President of TESARO, will participate in two investment conferences in FebruaryVical Incorporated (Nasdaq:VICL)today announced that the company will report financial results for the three months and twelve months ended December 31, 2013, before the opening of trading on Wednesday, February 12, and conduct a conference call and webcast to discuss the financial results and provide a company update at noon Eastern Time on Wednesday, February 12.

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