On December 5, 2017 Medidata (NASDAQ:MDSO), the leading global provider of cloud-based technology and data analytics for clinical research, reported that CytomX Therapeutics, Inc., a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, will expand its partnership to include Medidata Regulated Content Management (RCM) solutions, eTMF Archive and SOP Management (Press release, CytomX Therapeutics, DEC 5, 2017, View Source [SID1234522418]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We’ve created a seamless offering with the Medidata platform that can facilitate everything during clinical research, from data collection and management to compliance"
Tweet this
With the addition of Medidata RCM, CytomX will now manage regulated and nonregulated content in a single, unified platform. Accessible through the Medidata Clinical Cloud, CytomX will integrate standard operating procedure (SOP) management and electronic trial master file (eTMF) archive to manage all content, data and workflows.

CytomX is also currently using Medidata Rave, the world’s leading solution for capturing, managing and reporting patient data and Medidata Balance, randomization and trial supply management (RTSM) application, for its oncology research studies.

"We’ve created a seamless offering with the Medidata platform that can facilitate everything during clinical research, from data collection and management to compliance," said Mike Capone, chief operating officer at Medidata. "Medidata’s industry difference is that we enable our customers to take control of their data, helping them meet regulatory requirements and ensure efficient clinical trials."

On December 5, 2017 Delcath Systems, Inc. (OTCQB:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, announces that results of a multi-center retrospective analysis of Delcath’s PHP Therapy have been accepted for publication in the peer-reviewed Journal of Surgical Oncology (Press release, Delcath Systems, DEC 5, 2017, View Source;p=RssLanding&cat=news&id=2321097 [SID1234522379]). The study, Percutaneous Hepatic Perfusion with Melphalan in Uveal Melanoma: A Safe and Effective Treatment Modality in an Orphan Disease, was conducted by researchers from Moffitt Cancer Center in Tampa, FL and the University Hospital Southampton in the United Kingdom. The publication of the data is expected in an upcoming edition of the Journal. An abstract of this study was presented at the 12th Annual Regional Therapies International Symposium in Snowbird, Utah in February 2017.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Commenting on the announcement, Jennifer K. Simpson, Ph.D., President and CEO of Delcath Systems, said, "this study represents the largest data set outside of a controlled clinical trial on the use of PHP Therapy in the treatment of uveal melanoma metastatic to the liver. Preliminary results of the study presented at the Regional Therapies conference earlier this year showed data indicating tumor response and overall survival benefit with PHP Therapy beyond the 6-8 months seen with other therapies in this patient population. The most common serious side effects following treatment were anemia, thrombocytopenia and neutropenia; these were expected and the majority managed with supportive care. The preliminary data provide confidence that our Phase 3 clinical trial in ocular melanoma liver metastases can provide the evidence necessary to support an application for a labeled indication in this tumor type, and we look forward to the publication of the full study results."

PHP Therapy with Melphalan/HDS was developed by Delcath Systems as a targeted, whole organ therapy for the liver. It is commercially available as a device in Europe, where it is marketed as CHEMOSAT. The system has not been approved by the U.S. Food and Drug Administration, and is undergoing Phase 3 clinical testing in the U.S. as an investigational product.

On December 5, 2017 Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to improve the survival and quality of life of cancer patients, will present clinical data from the Phase 3 DUO study evaluating the efficacy and safety of duvelisib in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) at a Research and Development reception at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2017 Annual Meeting (Press release, Verastem, DEC 5, 2017, View Source;p=RssLanding&cat=news&id=2321050 [SID1234522395]). The event will take place on Sunday, December 10, 2017 in Atlanta.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The event, which follows the oral presentation of the DUO data results at ASH (Free ASH Whitepaper), will feature a slide presentation and moderated panel discussion with recognized experts in the treatment of hematologic malignancies, including CLL/SLL, and a live Q&A session. Speakers will include Ian Flinn, MD, PhD, Sarah Cannon Research Institute, who will present results from the Phase 3 DUO study, and Steven Horwitz, MD, Memorial Sloan Kettering Cancer Center, who will provide an update on duvelisib for the treatment of Peripheral T-Cell Lymphoma (PTCL). In addition, Lori Kunkel, MD, Verastem Clinical and Scientific Advisory Board, and Steven Bloom, Verastem Chief Strategy Officer, will participate in the discussion panel and Q&A session, which will be moderated by Robert Forrester, Verastem President and Chief Executive Officer.

The event will take place during the ASH (Free ASH Whitepaper) 2017 Annual Meeting and is open to analysts and institutional investors. Interested parties can access a live webcast of the event beginning Sunday, December 10, 2017 at 8:15 p.m. ET on the "Presentations" page of the company’s website View Source;p=irol-calendar. A replay of the webcast will be archived on the company’s website for 90 days following the event. For more information or to RSVP, please contact Maeve Conneighton at [email protected].
Duvelisib is Verastem’s first in class oral dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma which is currently being developed for the treatment of CLL/SLL, peripheral T cell lymphoma (PTCL), and other hematologic malignancies.

On December 5, 2017 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the MD Anderson Cancer Center ("MD Anderson"), reported the physician-sponsored Investigational New Drug ("IND") application for a Phase I trial of Moleculin’s drug WP1066 in patients with recurrent malignant glioma and brain metastasis from melanoma has been allowed by the US Food and Drug Administration ("FDA") (Press release, Moleculin, DEC 5, 2017, View Source [SID1234522382]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are so pleased to now have a second drug enter the clinical stage," commented Walter Klemp, Chairman and CEO of Moleculin. "We believe WP1066 represents a new class of anticancer drugs able to fight tumors on two fronts by directly inhibiting cell signaling supporting tumor activity, and independently stimulating a natural immune response. This constitutes a new approach to treating brain tumors and tumor metastasis to the brain.

Mr. Klemp concluded, "Since the discovery of WP1066 at MD Anderson by Prof. Waldemar Priebe, it has now been studied by many independent groups and is widely recognized as a potent inhibitor of the activated form of a protein called STAT3, which has been implicated in many difficult to treat tumors, including brain tumors. Animal studies have shown that inhibition of STAT3 directly blocks tumor proliferation and its survival, while most importantly boosting the immune system’s ability to fight cancer. We finally have our first opportunity for a clinical proof of concept and confirmation of promising preclinical activity."
This IND was sponsored by Dr. Amy Heimberger, who will serve as the principal investigator for the Phase I trial at MD Anderson Cancer Center to evaluate safety and efficacy. Details about the trial can be viewed on www.clinicaltrials.gov.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!