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EISAI RECEIVES APPROVAL FOR ANTICANCER AGENT LENVIMA(R) IN SOUTH KOREA

On October 9, 2015 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that it has received marketing approval of its novel in-house developed anticancer agent Lenvima (lenvatinib mesylate) as a treatment for patients with progressive, locally recurrent or metastatic, differentiated thyroid carcinoma (DTC), refractory to radioactive iodine (RAI) from the regulatory authority in South Korea (Ministry of Food and Drug Safety) (Press release, Eisai, OCT 8, 2015, View Source [SID:1234507678]). The marketing authorization application for Lenvima in South Korea was submitted in November 2014, and through the approval of this application, South Korea is the first country in Asia where Lenvima has been approved following Japan, the United States and Europe.

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The decision to approve Lenvima in South Korea was based on the results of a pivotal Phase III study (the SELECT study) on DTC. In the study, Lenvima demonstrated a statistically significant extension in progression-free survival compared to placebo, as well as a high objective response rate.1 The most common Lenvima treatment-related adverse events were hypertension, diarrhea, fatigue or asthenia, decreased appetite, weight loss and nausea.

Discovered at Eisai’s Tsukuba Research Laboratories and developed in-house, Lenvima is an orally administered molecular targeted agent that selectively inhibits the activities of several different molecules including VEGFR, FGFR, RET, KIT and PDGFR. In particular, the agent simultaneously inhibits VEGFR, FGFR and also RET, which are especially involved in tumor angiogenesis and proliferation of thyroid cancer. Furthermore, Lenvima has been confirmed through X-ray co-crystal structural analysis to demonstrate a new binding mode (Type V) to VEGFR2, and exhibits rapid binding to the target molecule and potent inhibition of kinase activity, according to kinetic analysis2.

Lenvima has already been launched in Japan, the United States and Europe, while in Asia, applications seeking marketing approval are undergoing regulatory review in Singapore, Macao, Hong Kong, Taiwan, Malaysia, India and Indonesia. Furthermore, Eisai is conducting a global Phase III study of Lenvima in hepatocellular carcinoma as well as Phase II studies of Lenvima in several other tumor types such as renal cell carcinoma and non-small cell lung cancer.

The number of patients newly diagnosed with thyroid cancer in 2012 in South Korea was estimated to be 33,000, and in Asia was estimated to be 144,000. Although treatment is possible for most types of thyroid cancer, there are few treatment options available once thyroid cancer has progressed, therefore it remains a disease with significant unmet medical needs.

Together with providing Lenvima as a new treatment option for thyroid cancer to patients in South Korea, Eisai is working to obtain marketing approval in each country in Asia. Furthermore, Eisai is committed to exploring the potential clinical benefits of Lenvima in order to further contribute to patients with thyroid cancer, and their families.

Synta Pharmaceuticals Announces Formation of Expert Oncology Panel

On October 8, 2015 Synta Pharmaceuticals Corp. (NASDAQ: SNTA) reported the formation of an Expert Oncology Panel to provide guidance on research and development strategies for the Company’s portfolio of novel oncology therapies (Press release, Synta Pharmaceuticals, OCT 8, 2015, View Source;p=RssLanding&cat=news&id=2095347 [SID:1234507676]).

Inaugural members of Synta’s Expert Oncology Panel include:

David E. Avigan, M.D. – Chief Section of Hematological Malignancies and Bone Marrow Transplantation, Beth Israel Deaconess Medical Center Associate Professor, Medicine, Harvard Medical School
Bruce Allan Chabner, M.D. – Director of Clinical Research, Cancer Center Massachusetts General Hospital Cancer Center
Jeffrey A. Engelman, M.D., Ph.D. – Director, Center for Thoracic Cancers Massachusetts General Hospital Cancer Center, Associate Professor of Medicine Harvard Medical School
F. Stephen Hodi, Jr., M.D. – Director, Melanoma Center Director, Center for Immuno-Oncology, Associate Professor of Medicine Harvard Medical School, Dana Farber Cancer Institute
Martin J. Murphy, D. MedSc, Ph.D., FASCO – Chairman and Chief Executive Officer AlphaMed Consulting, Inc.
Neil Lee Spector, M.D. – Associate Professor of Medicine, Sandra Coates Associate Professor, Associate Professor of Pharmacology & Cancer Biology, Member of the Duke Cancer Institute

"It is our pleasure to welcome a group of world-renowned physicians and scientists to our newly formed Expert Oncology Panel," said Chen Schor, President and Chief Executive Officer of Synta. "We expect that this panel will lend important perspective in translating the breadth of emerging preclinical and clinical data with ganetespib into well designed clinical studies aimed at providing meaningful clinical benefits to cancer patients in selected indications. The advice of the panel will also be important in shaping our HDC program strategy as we move towards the clinic with the first candidate from this program, STA-12-8666, and consider additional payloads for development. This distinguished expert panel, together with our newly appointed Chief Scientific Officer, Dr. Alan Rigby, is taking Synta one step further in our mission to discover, develop and commercialize oncology medicines that change cancer patients lives."

Dr. Avigan is Professor, Department of Medicine, Harvard Medical School, Chief, Hematological Malignancy and Bone Marrow Transplant section at Beth Israel Deaconess Medical Center and a co-Clinical Leader of the Leukemia Program at the Dana Farber Harvard Cancer Center. He leads a translational research program for hematological malignancies with a focus on vaccine therapy, tumor immunology, and stem cell biology with a strong track record for clinical translation of biologic based treatments. Dr. Avigan earned his M.D. from Yale University School of Medicine, completed his residency at Columbia Presbyterian Medical Center in Internal Medicine, and his fellowship at Memorial Sloan-Kettering Cancer Center in Hematology/Oncology.

Dr. Chabner is the Clinical Director, Emeritus, and Paul G. Allen Scholar at the Massachusetts General Hospital Cancer Center. During his career at the National Cancer Institute (NCI), he served as a Senior Investigator in the Laboratory of Chemical Pharmacology, Chief of the Clinical Pharmacology Branch, Director of the Clinical Oncology Program, and Director of the Division of Cancer Treatment. At the NCI, he maintained an active laboratory program in cancer pharmacology, and led the development of Taxol. His research contributed significantly to the development of high dose chemotherapy regimens, and to standard therapies for lymphoma. Dr. Chabner is the Editor in Chief for The Oncologist and serves on the executive advisory boards for some of the industry’s leading innovators in drug development. In 2006, Dr. Chabner received a presidential appointment to the National Cancer Advisory Board at the NCI, which he chaired from 2010 to 2012. Dr. Chabner earned his M.D. at Harvard Medical School, completed his residency at Brigham and Women’s Hospital, and his fellowships at the NCI and Yale-New Haven Hospital.

Dr. Engelman is the Director, Center for Thoracic Cancers at the Massachusetts General Hospital Cancer Center and an Associate Professor of Medicine at the Harvard Medical School. The overarching aim of research in the Engelman laboratory at Mass General is to develop new and more effective therapeutic strategies for the treatment of cancer, with a particular emphasis on lung cancer. Dr. Engelman is board certified in medical oncology and earned his M.D. and Ph.D. from the Albert Einstein College of Medicine. He completed his residency at Brigham and Women’s Hospital and Fellowship at the Dana Farber Cancer Institute and Massachusetts General Hospital combined program.

Dr. Hodi is the Director of the Melanoma Center and the Center for Immuno-Oncology at Dana-Farber/Brigham and Women’s Cancer Center and Assistant Professor of Medicine at Harvard Medical School. He received his M.D. degree from Cornell University Medical College in 1992. Dr. Hodi competed his postdoctoral training in Internal Medicine at the Hospital of the University of Pennsylvania, and Medical Oncology training at Dana-Farber Cancer Institute where he joined the faculty in 1995. His research focuses on gene therapy, the development of immune therapies, and first into human studies for malignant melanoma. Dr. Hodi is a member of the National Comprehensive Cancer Network, the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), the Eastern Cooperative Oncology Group Melanoma Committee, the International Society for the Biological Therapy of Cancer, and a founding member of the Society for Melanoma Research.

Dr. Murphy is the Founding Chairman and Chief Executive Officer of AlphaMed Consulting, Inc., a consultancy that provides strategic support for academic cancer centers and cancer drug development programs of global pharmaceutical and biotechnology companies. He is the founding Executive Editor of three journals: The Oncologist, Stem Cells and of Stem Cells Translational Medicine. Dr. Murphy was founding Chief Executive Officer of Hipple Cancer Research Center and an NIH principal investigator who merited more than $25 million in competitive NIH grants. He is Co-founder of the Society for Translational Oncology, a member of the Scientific Advisory Board of Hatteras Venture Partners, a charter member of the International Advisory Board of Amsterdam’s VU University Medical Imaging Center, a charter member of Queen’s University-Belfast School of Medicine International Review Board, Chairman Emeritus of the Conquer Cancer Foundation of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), convener of ACT-China, and Steering Committee Member and Senior Consultant of the Chinese Society of Clinical Oncology. He is also a member of the National Cancer Policy Forum of the National Academy of Medicine of the United States National Academy of Sciences, a director of the Foundation for the National Institutes of Health, a member of the Board of Visitors of the UNC Lineberger Comprehensive Cancer Center, a member of the Board of Advisors of the H. Lee Moffitt Cancer Center & Research Institute and a charter member and vice chairman of C-Change, founded by former President George H.W. Bush and former First Lady Barbara Bush. Dr. Murphy is a Fellow of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and is Founding Chief Executive Officer of the non-profit CEO Roundtable on Cancer at the request of the Forty-First President George H.W. Bush.

Dr. Spector is the Sandra Coates Chair Breast Cancer Research at the Duke University Medical Center, Leader of the Developmental Therapeutics Program, Duke Cancer Institute, and currently serves as Scientific Advisor to Synta. Prior to joining Duke, Dr. Spector served as Director of GlaxoSmithKline’s Exploratory Medical Sciences in Oncology, where he successfully guided the development of Tykerb (lapatinib) and Arranon (nelarabine) from initial preclinical studies through clinical development and eventual FDA approval. Dr. Spector is board-certified in Hematology, Medical Oncology and Internal Medicine and earned his M.D. at the University of Medicine and Dentistry of New Jersey. He completed his residency in Internal Medicine at Parkland Memorial Hospital, University of Texas, Southwestern Medical Center and in Medical Oncology/Hematology at the Dana Farber Cancer Institute and Massachusetts General Hospital combined program.

Nymox Announces Prostate Cancer Clinical Trial Will Complete Prospective 18 Month Post-Treatment Assessments

On October 08, 2015 Nymox Pharmaceutical Corporation (NASDAQ:NYMX) reported that that participants in prostate cancer clinical trial NX03-0040 had neared completion of the study’s 18 month post-treatment assessments (Press release, Nymox, OCT 8, 2015, View Source;fvtc=4&fvtv=6907 [SID:1234507673]). The results from this 18 month study are expected to be reported this quarter, after the 18 month data has been analyzed. Patients in the prostate cancer study have been followed for up to 39 months after treatment.

Study NX03-0040 is a Phase 2 study of NX-1207 for low grade localized prostate cancer. The study was initiated in 2012. 146 men were randomized to a single injection of NX-1207 at two dosage levels (2.5 mg or 15 mg) or standard of care.

Prostate cancer is the most commonly diagnosed cancer in men, other than skin cancer, and is the second leading cause of cancer death for men. Approximately 50% of prostate cancers are initially considered low risk.

To date, NX-1207 has had an excellent safety profile. NX-1207 has shown safety in 9 clinical trials (BPH and prostate cancer) including repeat injection studies. The drug does not lead to immune responses such as antibody formation which can cause significant drug toxicity and/or limit usage to single treatments due to drug neutralizing effects.

One of the major problems with current prostate treatments for localized prostate cancer (radical prostatectomy, external beam radiation, or brachytherapy) is the relatively high incidence of reported sexual dysfunction post-treatment. In 9 studies, NX-1207 treatment has been shown to have no significant adverse effect post-treatment on sexual function or testosterone levels.

– See more at: View Source;fvtc=4&fvtv=6907#sthash.pN0IAlVD.dpuf

Myriad Genetics to Highlight New Clinical Outcomes Data on myPath(R) Melanoma at the American Society of Dermatopathology Annual Meeting

On October 8, 2015 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that new clinical outcomes and clinical utility data for myPath Melanoma will be featured at the American Society of Dermatopathology (ASDP) 52nd meeting being held Oct. 8 to 11, 2015 in San Francisco, Calif (Press release, Myriad Genetics, OCT 8, 2015, View Source [SID:1234507671]). The findings add to the growing body of knowledge for myPath Melanoma and will support the Company’s clinical reimbursement dossier for the product.

"The accurate diagnosis of melanoma can be challenging based on histologic findings alone and there are potentially severe consequences of a misdiagnosis, including the under-treatment or overtreatment of patients," said Loren Clarke, M.D., vice president, Medical Affairs for Dermatology, Myriad Genetic Laboratories. "Our studies show that myPath Melanoma accurately differentiates malignant melanoma from benign skin lesions and helps physicians deliver a more objective and confident diagnosis for their patients."

A list of the myPath Melanoma presentations at ASDP (#ASDP2015) follows.

Podium Presentation

Title: Correlation of myPath Melanoma gene expression score with clinical outcome on a series of melanocytic lesions.

Date: Saturday, Oct. 10, 2015: 3:00 p.m. PT.

Location: Hilton Union Square, Continental 4-6.

Eugen Minca, M.D., department of Pathology, Cleveland Clinic, will present a study that correlates myPath Melanoma test results with clinical outcomes data (e.g., recurrence, sentinel lymph node metastases and distant metastases) from 127 patients with melanocytic lesions. Of these cases, 65 lesions were melanomas and 62 were benign lesions, according to the pathology diagnosis. The myPath Melanoma test scores were reviewed in conjunction with the diagnosis and clinical outcome. Of the 65 melanomas, 14 developed metastases and 51 had no adverse events after 47 months of follow up and myPath Melanoma diagnosed malignancy in all 14 cases with adverse outcomes, which represents a 100 percent sensitivity rate in these metastatic cases. There were no adverse events associated with the 62 benign lesions after an average follow up of 30 months. Of these, the myPath Melanoma test produced a benign score in 48 cases, an indeterminate score in seven cases and a malignant score in seven cases. Importantly, after myPath testing and upon expert histologic review, three of the seven cases with a malignant score were reclassified as melanomas. This is the first study with clinical outcome data and supports previous validation studies demonstrating that the myPath Melanoma test provides additional insight into difficult-to-diagnose lesions, supporting its use as an ancillary diagnostic test.

Poster Presentation

Title: A retrospective study of the influence of a gene expression signature on the treatment of melanocytic tumors.

Date: Thursday, Oct. 8 from 1:00 p.m. PT to Oct. 11 at 11:00 a.m. PT.

Location: Golden Gate, Ballroom.

In this study, 632 difficult-to-diagnose melanocytic lesions were analyzed using the myPath Melanoma diagnostic test. Retrospective chart reviews were conducted for 315 of the cases to document the actual treatment carried out for each patient. Of these, 214 patients received a benign myPath Melanoma test result, 92 received a malignant result and nine received an indeterminate result. The percentage change was measured from the treatment recommendations of the expert dermatopathologists to the actual treatment provided by dermatologists. The results show that excisions were reduced by 33.1 percent in patients who received a benign myPath Melanoma test result. Conversely, the use of additional treatment, such as surgery, increased by 36.2 percent in patients who received a malignant myPath Melanoma test result. These data support the integration of the myPath Melanoma test into medical practice to improve patient care by allowing more definitive diagnoses by dermatopathologists and optimized treatment decisions by dermatologists.

About myPath Melanoma

myPath Melanoma is a clinically validated gene expression test designed to differentiate malignant melanoma from benign nevi across all major melanoma subtypes. Myriad myPath Melanoma is a unique test of 23 genes that provides valuable, additive diagnostic information unavailable from any other method – information that can help physicians deliver a more confident diagnosis.

Melanoma is the most serious type of skin cancer. According to the American Cancer Society, about 76,000 new melanomas are diagnosed each year and more than 9,000 people die from the disease annually. Each year in the United States, there are approximately 1.5 million skin biopsies performed specifically for the diagnosis of melanoma, and approximately 14 percent or 210,000 biopsies are classified as indeterminate, meaning that the dermatopathologist cannot confidently determine whether the cells are benign or malignant. For more information visit: www.mypath.myriad.com and www.mypathmelanoma.com.

Delcath Announces National Reimbursement Coverage For CHEMOSAT Procedures In Germany

On October 8, 2015 Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, reported the establishment of a national reimbursement code for procedures performed with the Delcath Hepatic CHEMOSAT Delivery System (CHEMOSAT) in Germany (Press release, Delcath Systems, OCT 8, 2015, View Source;p=RssLanding&cat=news&id=2095411 [SID:1234507669]). The German Institute for the Hospital Remuneration System (InEK) issued a ZE diagnostic-related group (DRG) code, which permits hospitals in Germany to obtain reimbursement for CHEMOSAT procedures beginning in 2016. This new nationwide code replaces the previous Neue Untersuchungs und Behandlungsmethoden (NUB) procedure that required patients in Germany to apply individually for reimbursement of their CHEMOSAT treatment. The decision represents the first national reimbursement mechanism for CHEMOSAT procedures in Europe.

"The receipt of ZE reimbursement represents an important step towards increased commercialization of CHEMOSAT and highlights the role our therapy has been playing in Germany for the treatment of patients with cancers in the liver," said Jennifer K. Simpson, Ph.D., MSN, CRNP, CEO & President of Delcath Systems, Inc. "The application for coverage under the ZE scheme was made by the German Radiology Society and has been widely supported by major German cancer hospitals, which also speaks to the confidence the German clinical community has in the therapy. With a ZE DRG code established, an application under the annual NUB process is no longer required. We look forward to supporting participating hospitals in their negotiations with insurers in the coming year and are pleased that this new reimbursement will make CHEMOSAT treatment more easily accessible to patients in Germany suffering with cancers in the liver."

ZE is a national reimbursement code that augments existing DRG codes until a specific new DRG code can be created. With the establishment of a ZE code for CHEMOSAT, the procedure is now permanently represented in the DRG catalog in Germany. The establishment of ZE coverage by InEK was made in response to an application made by the German Radiology Society for CHEMOSAT in March 2015.