Physicians’ Education Resource® Presents the 23rd Annual International Congress on Hematologic Malignancies®: Focus on Leukemias, Lymphomas, and Myeloma

On January 28, 2019 Physicians’ Education Resource (PER), a leading resource for continuing medical education (CME), reported that it will host its 23rd annual International Congress on Hematologic Malignancies: Focus on Leukemias, Lymphomas, and Myeloma from Thursday, Feb. 28 to Sunday, March 3 at the Eden Roc Miami Beach in Florida (Press release, Physicians’ Education Resource, JAN 28, 2019, View Source [SID1234532924]).

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This dynamic Winter Hematology congress will be co-chaired by Andre Goy, M.D., M.S., the chairman and executive director of the lymphoma division and chief of the John Theurer Cancer Center at Hackensack University Medical Center, chief science officer and director of research and innovation of the Regional Cancer Care Associates; Sagar Lonial M.D., FACP, a professor and executive vice chair in the department of hematology and medical oncology at Emory School of Medicine, and chief medical officer of Winship Cancer Institute of Emory University; and Jorge Eduardo Cortes, M.D., the D.B. Lane Cancer Research Distinguished Professor for Leukemia Research, deputy chair and professor of medicine, and an internist in the department of leukemia, division of cancer medicine at The University of Texas MD Anderson Cancer Center.

"Our winter hematology congress continually offers the latest updates and insights in the evolving field of hematologic oncology," said Phil Talamo, president of PER. "With all the recent advancements this past year, this conference will discuss new data and challenge participants to apply new information they have learned, reflect on new practices they can bring back to their clinics to share with their peers, and ultimately improve patient outcomes."

The 23rd annual congress is a three-and-a-half-day engaging and highly interactive meeting that provides community-based hematologists and medical oncologists interested in the treatment of hematologic malignancies with the opportunity to interact with internationally renowned experts in the management of leukemias, lymphomas, myeloma, myelodysplastic syndromes, myeloproliferative neoplasms, and benign hematologic malignancies. During the congress, faculty experts will review latest information on pressing topics for 2019, including the expanding role of new immunologic approaches, including CAR T cells and checkpoint inhibitors, the emergence of molecular-based therapies and new cytotoxic formulations in patients with acute leukemias, new approaches for treatment and duration of therapy among patients with myeloproliferative neoplasms and more. The meeting will also feature several engaging Medical Crossfire discussion panels interspersed throughout the meeting to allow attendees to explore some of the most challenging clinical situations in the management of hematologic malignancies.

Oragenics, Inc. Receives Further Validation for Lantibiotic Compound OG716

On January 28, 2019 Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis ("OM"), reported the publication of a preclinical study using the lead compound from its lantibiotics program, OG716, in the peer reviewed journal, Antimicrobial Agents and Chemotherapy (Press release, Oragenics, JAN 28, 2019, View Source [SID1234532923]).

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The preclinical study demonstrated that following oral administration of the maximum feasible dose of OG716 in hamster models, there were no observable toxicities nor observable side effects, nor was there any effect on intestinal motility. Treatment of animals infected with C. difficile resulted in a dose-dependant survival, and no recurrence at the upper dose tested. Further, researchers observed that the compound remained constrained only in the gastrointestinal tract. Lantibiotics, including OG716, are a novel class of peptide antibacterial compounds naturally produced by a variety of Gram-positive bacteria. Oragenics’ lantibiotic library offers a large pipeline for the development of novel antibiotics in several indications.

"The publication of this study offers additional validation for the safety and tolerability of our lantibiotic program, while simultaneously confirming the potential for our lead candidate for the treatment of CDAD," stated Alan Joslyn, Ph.D., President and CEO of Oragenics, Inc. "There exists a dire need for new approaches to fighting antibiotic-resistant infections, and we believe the continued development of our lantibiotic program is one of those potential solutions. We look forward to providing continued updates on the development of OG716 as they become available."

The manuscript is available on-line at View Source

About Lantibiotics and OG716

OG716 is a molecule derived from Oragenics’ lantibiotic discovery and characterization platform that has shown positive results in nonclinical testing including efficacy in an animal model for Clostridium difficile infection in enteritis. Lantibiotics are a class of antibiotic compounds with novel mechanism of action, prized for their ability to overcome antibiotic-resistant infections. With resistant strains on the rise, particularly healthcare-acquired infections (HAI), the need for these potent lantibiotic agents is critical. Oragenics is pursuing the commercial-scale production of a lantibiotic for use as an antimicrobial.

Advaxis To Present An Overview Of Its Lm Platform And New Information On Its Neoantigen-Directed Therapy Programs At The Immuno-Oncology 360° Conference

On January 28, 2019 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that an overview of the Company’s proprietary Lm platform and new information regarding the Company’s neoantigen-directed therapy programs, ADXS-NEO (customized, personalized neoantigens) and ADXS-HOT (off-the-shelf, hotspot or shared neoantigens and other antigens), will be presented during a plenary session at the Immuno-Oncology 360° conference on February 6, 2019 (Press release, Advaxis, JAN 28, 2019, View Source [SID1234532920]). The conference is being held at the Crowne Plaza Times Square in New York City; the plenary session begins at 4:00 p.m. ET and the Advaxis presentation is scheduled to begin at 4:40 p.m. ET.

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The presentation will be made by Andres A. Gutierrez, M.D., Ph.D., Chief Medical Officer and Executive Vice President of Advaxis, and Robert G. Petit, Ph.D., Chief Scientific Officer and Executive Vice President of Advaxis. Advaxis intends to issue a news release on February 6, 2019, that summarizes the presentation by Drs. Gutierrez and Petit.

ADXS-NEO, the Company’s personalized neoantigen program, is in an ongoing Phase 1 dose-escalation study to treat a variety of cancers. ADXS-HOT is the Company’s off-the-shelf program and consists of several different drug constructs which target hotspot or shared neoantigens, and other antigens. The first drug construct from this program is ADXS-503, or HOT-Lung, for the treatment of non-small cell lung cancer. ADXS-503 is expected to enter the clinic this quarter.

Diplomat to Release 2018 Financial Results, 2019 Guidance Feb. 25

On January 28, 2019 Diplomat Pharmacy, Inc. (NYSE: DPLO), reported that it will report its fourth-quarter and year-end 2018 financial results — and provide 2019 guidance — after market close Monday, Feb. 25 (Press release, Diplomat Speciality Pharmacy, JAN 28, 2019, View Source [SID1234532919]). A conference call and live webcast will follow at 5 p.m. ET.

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Shareholders and other interested parties can listen to the conference call live by dialing 833.286.5805 (647.689.4450 for international callers). Participation code 2672528 will start working about 15 minutes before the call. A live webcast will be available on the investor relations section of Diplomat’s website at ir.diplomat.is. An audio recording and related materials will be available online for approximately 90 days.

4SC’s pivotal RESMAIN study of resminostat in CTCL receives second positive safety review

On January 28, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported that the Data Safety Monitoring Board (DSMB), an independent committee of clinical and drug safety experts, again recommends continuation of the ongoing pivotal RESMAIN study without modification of the study protocol (Press release, 4SC, JAN 28, 2019, View Source [SID1234532918]). Per the protocol’s pre-specified DSMB charter, the second DSMB meeting was scheduled recently to review cumulative safety data after 100 patients have been enrolled and completed at least one treatment cycle.

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RESMAIN is conducted as a multi-center, double blind, randomized, placebo-controlled study. It evaluates resminostat for maintenance treatment of patients with advanced-stage cutaneous T-cell lymphoma (CTCL) who have achieved disease control with prior systemic therapy, at more than 50 clinical centers in 11 European countries and Japan. The study is progressing on track, recruitment is expected to complete in 2019 and top-line results are expected in the first half of 2020.

Susanne Danhauser-Riedl, M.D., Chief Medical Officer of 4SC, commented: "We are encouraged by the positive outcome of the second independent DSMB safety review and aim to bring resminostat to patients as quickly as possible to achieve an improvement in their quality of life.

Advanced-stage CTCL patients usually respond to available treatment options but the duration of response is often short-lived and declines as the severity of the disease increases. The aim of a maintenance therapy and thus of our RESMAIN study is to make such remissions more durable, halting disease progression."