On September 5, 2018 Athenex, Inc. (NASDAQ:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that the planned second interim analysis of the Oraxol 001 Phase III Clinical Trial in metastatic breast cancer has been conducted and reviewed by an independent Drug Safety Monitoring Board (DSMB) (Press release, Athenex, SEP 5, 2018, View Source;p=RssLanding&cat=news&id=2366074 [SID1234529329]). The DSMB congratulated Athenex on the rapid patient recruitment and the promising results achieved. The DSMB noted that more than 320 patients have already been recruited and recommended that Athenex continue this study and complete the recruitment of patients.

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The Oraxol 001 Phase III Clinical Trial is a randomized controlled clinical trial comparing Oraxol monotherapy against intravenous (IV) paclitaxel monotherapy in patients with metastatic breast cancer. The study is designed to compare the safety and demonstrate the superiority of Oraxol over IV paclitaxel. Clinical activity is based on confirmed response rate as assessed by RECIST Criteria, a generally accepted clinical response criteria for efficacy in tumor reduction. Assessment of tumors scans are made by a blinded independent radiologic imaging analysis center.

Dr. Rudolf Kwan, Athenex’s Chief Medical Officer, commented, "After review of the efficacy and safety data of this Oraxol Phase III clinical trial, the unanimous recommendation by the DSMB to continue this study represents the achievement of another critical milestone for Oraxol. We plan to provide these confidential unblinded data to regulatory authorities soon to discuss the marketing submission pathways. In the mean time, we will continue to rapidly advance this clinical trial."

Dr. Johnson Lau, Athenex’s Chairman of the Board and Chief Executive Officer, stated, "The positive recommendation of the DSMB regarding the Oraxol Phase III study in patients with metastatic breast cancer, in combination with the successful completion of two Phase III clinical studies for KX-01 for Actinic Keratosis ahead of schedule as previously announced on July 26, 2018, together underscore the excellent execution by our clinical research and development team."

On September 5, 2018 Cytokinetics, Inc. (Nasdaq: CYTK) reported that Robert I. Blum, President and Chief Executive Officer, is scheduled to present a corporate update at the 16th Annual Morgan Stanley Global Healthcare Conference on Wednesday, September 12, 2018 at 11:40 AM ET at the Grant Hyatt in New York City (Press release, Cytokinetics, SEPT 5, 2018, View Source [SID1234529290]).

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Interested parties may access the live webcast of this presentation by visiting the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The webcast replay of the presentation will be archived on the Presentations page within the Investors & Media section of Cytokinetics’ website for 90 days following the conclusion of the event.

On September 5, 2018 Exelixis, Inc. (NASDAQ: EXEL) reported that Michael M. Morrissey, Ph.D., the company’s President and Chief Executive Officer, will provide an overview of the company at the Morgan Stanley Global Health Care Conference taking place September 12-14 in New York, NY (Press release, Exelixis, SEPT 5, 2018, View Source;p=irol-newsArticle&ID=2366220 [SID1234529291]). The Exelixis presentation is scheduled for 1:05 PM EDT / 10:05 AM PDT on Wednesday, September 12, 2018.

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcast. A replay will also be available at the same location for 14 days.

On September 5, 2018 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that data from the PD-(L)1 refractory non-small cell lung cancer (NSCLC) cohort of ENCORE 601 will be presented at the upcoming International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer (WCLC) being held September 23-26, 2018 in Toronto, Canada (Press release, Syndax, SEPT 5, 2018, View Source [SID1234529292]). ENCORE 601 is a Phase 1b/2 trial evaluating the efficacy and safety of entinostat, the Company’s class I selective HDAC inhibitor, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, across multiple cohorts of PD-(L)1 treatment-naïve and pre-treated cancers, including NSCLC, melanoma and microsatellite stable colorectal cancer.

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The accepted abstract is available on the World Conference on Lung Cancer website at View Source Updated data will be presented at the conference.

Presentation Details

Title: Efficacy/Safety of Entinostat (ENT) and Pembrolizumab (PEMBRO) in NSCLC Patients Previously Treated with Anti-PD-(L)1 Therapy
Presenter: Matthew D. Hellmann, M.D., Memorial Sloan Kettering Cancer Center
Track: Advanced NSCLC
Session: OA05 – Clinical Trials in IO
Presentation Number: OA05.01
Date and Time: September 24, 2018 1:30 – 1:40 PM ET

On September 5, 2018 DiaMedica Therapeutics Inc. (the "Company" and "DiaMedica") (TSX-V:DMA) (OTCQB:DMCAF) reported the recent appointment of Harry Alcorn Jr. Pharm.D. as Chief Medical Officer where he will oversee global clinical development and regulatory initiatives for DiaMedica (Press release, DiaMedica, SEP 5, 2018, View Source [SID1234529333]). Dr Alcorn has over 30 years of clinical research experience working with public and private biotech and pharmaceutical companies in studies of kidney diseases and diabetic, hepatic and cardiovascular patients. He has designed, authored and been a consultant to a multitude of companies in the industry on protocol development, clinical execution and regulatory guidance. He has served as Principal Investigator or Sub Investigator in over 450 clinical studies and has assisted many biotech and pharmaceutical companies in negotiating protocols and presenting results to the FDA. Dr. Alcorn has presented at numerous international meetings and industry seminars discussing the critical challenges in conducting patient studies.

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Prior to joining DiaMedica, Dr. Alcorn served as Chief Scientific Officer at DaVita Clinical Research (DaVita), a company that provides clinical research services for pharmaceutical and biotech companies. During this time, he also served on the Board of Directors for The Association of Clinical Pharmacology Units and on the Board of Directors of MedTox Laboratories. In 2000 Dr. Alcorn started the US Renal Network, the first organization to coordinate clinical trial sites for the conduct of kidney studies. Prior to DaVita he held the position of Executive Director and led the clinical trials at GalaGen Inc, a biopharmaceutical company developing therapeutics to target life-threatening and emerging pathogens.

Dr. Alcorn obtained his Bachelor of Pharmacy from Creighton University and his Doctor of Pharmacy from University of Nebraska Medical Center. He currently holds clinical faculty appointments with the University of Minnesota, Creighton University, University of Nebraska Medical Center, Virginia Commonwealth and the University of Colorado, Denver.

"We are thrilled that Harry is bringing to DiaMedica his strong industry and operational leadership at a time when we are preparing to initiate clinical research in patients with Chronic Kidney disease" commented Rick Pauls, President and CEO of DiaMedica. "His knowledge, experience in patient trials, along with his work as a subject matter expert for both industry and the FDA, complements our team."
I am very excited to join DiaMedica at this stage of its development," said Dr. Alcorn. "DiaMedica is leading the investigation of the KLK1 protein and has the opportunity to significantly improve the lives of patients suffering from chronic kidney disease and neurological disorders. I look forward to helping the company accelerate the development of DM199 for these patients."

About DM199

DM199 is a recombinant (synthetic) form of the human protein known as "KLK1". The KLK1 protein plays an important role in the regulation of diverse physiological processes including blood flow, inflammation, fibrosis, oxidative stress and neurogenesis via a molecular mechanism that increases production of nitric oxide and prostacyclin. KLK1 deficiency may play a role in multiple vascular and fibrotic diseases such as chronic kidney disease, retinopathy, stroke, vascular dementia and treatment resistant hypertension where current treatment options are limited or ineffective. DiaMedica is the first company to have developed a recombinant form of the KLK1 protein. The KLK1 protein, produced from porcine pancreas and human urine, has been used to treat patients in Japan, China and Korea for decades. DM199 is currently being studied in patients with acute ischemic stroke and DiaMedica is preparing to initiate a clinical study in patients with chronic kidney disease.