On February 28, 2018 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported an update on its Phase II clinical trial with drug candidate Namodenoson (CF102) in the treatment of NAFLD/NASH (Press release, Can-Fite BioPharma, FEB 28, 2018, View Source [SID1234524224]).

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The current Phase II study is being conducted in three Israeli sites including Hadassah Medical Center, Jerusalem and the Rabin Medical Center, Petach Tikva. Patients who suffer from NAFLD/NASH with evidence of active inflammation are treated twice daily with 12.5 or 25 mg of oral Namodenoson vs. placebo. The primary end point of the Phase II study is the anti-inflammatory effect of the drug, as determined by ALT blood levels, and the secondary end points include percentage of liver fat, as measured by MRI-PDFF (proton density fat fraction). The company anticipates the completion of patient enrollment toward the end of 2018 and data release in the first half of 2019.

Recent safety data showed that Namodenoson has a favorable profile and lack of hepatotoxicity in patients. Preclinical data demonstrate robust anti-inflammatory, anti-fibrogenic and anti-steatotic effects, supporting its development for the NAFLD/NASH indication.

Can-Fite CEO Dr. Pnina Fishman commented, "We are pleased with the progress so far in our clinical trial with Namodenoson for the treatment of NAFLD/NASH, and we look forward to data release later in H1/2019."

There is currently no U.S. FDA approved drug for the treatment of NASH, which is an addressable pharmaceutical market estimated to reach $35-40 billion by 2025.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On February 28, 2018 Navidea Biopharmaceuticals (NYSE MKT: NAVB) ("Navidea" or "the Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported it will host a conference call on March 8, 2018 at 4:30pm E.T. to discuss its financial results for the fourth quarter and full year 2017, in conjunction with the filing of its annual report on Form 10-K for the fourth quarter and full year results ended December 31, 2017 (Press release, Navidea Biopharmaceuticals, FEB 28, 2018, View Source [SID1234524252]).

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Michael Goldberg, President and Chief Executive Officer, and Jed Latkin, Chief Financial and Operating Officer of Navidea, will host the call and provide an update on recent developments and clinical progress. Management will be answering questions live immediately following the earnings announcement part of the call.

To participate in the call, please dial +1 646-828-8143 (toll-free) in the U.S. and Canada. The conference ID number is 1826783.

Event: FY+ 2017 Earnings and Business Update Conference Call
Date: Thursday, March 8th, 2018
Time: 4:30pm E.T.
U.S. & Canada Dial-in: +1 646-828-8143 (toll free)
Conference ID: 1826783

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

Pacira Pharmaceuticals has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Pacira Pharmaceuticals, 2018, FEB 28, 2018, View Source [SID1234524217]).

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On February 28, 2018 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 a reminder that it will host a conference call this afternoon to discuss the recent discovery of a new molecule for cancer treatment and provide a business update (Press release, Moleculin, FEB 28, 2018, View Source [SID1234524245]). The call will be at 4:30 p.m. ET on Wednesday, February 28, 2018.

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Participants can dial (800) 860-2442 or (412) 858-4600 to access the conference call, or can listen via a live Internet web cast, which is available in the Investor Relations section of the Company’s website at www.moleculin.com. A replay of the call will be available by visiting www.moleculin.com for the 90 days after the call or by calling (877) 344-7529 or (412) 317-0088, confirmation code 10117548, through March 7, 2018.

On February 28, 2018 Actinium Pharmaceuticals, Inc. (NYSE American:ATNM) ("Actinium" or "the Company") reported its progress and activity at the recently concluded BMT Tandem Meetings, the combined annual meetings of the American Society of Blood and Marrow Transplantation (ASBMT) and the Center for International Blood & Marrow Transplant Research (CIBMTR) (Press release, Actinium Pharmaceuticals, FEB 28, 2018, View Source [SID1234524220]). Actinium’s lead product candidate, Iomab-B, is currently being studied in a pivotal Phase 3 trial as a myeloablative conditioning agent prior to a bone marrow transplant. Recently, Actinium announced that it had amended the protocol of its pivotal Phase 3 SIERRA trial to expand the number of salvage chemotherapy agents included in the control arm. The response from clinical trial principal investigators to this change has been positive. In addition, Actinium recently announced that it had activated Stony Brook University as the 16th clinical trial site in the SIERRA trial.

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Dr. Mark Berger, Chief Medical Officer of Actinium said, "As we have made significant progress with the SIERRA trial, we recognized that the regimens in the control arm needed to be expanded, based largely on feedback from our investigators and advisory board. We believe that investigators recognized the imbalance between groups, evidenced by the crossover component of the trial, so we were eager to make these changes, which have been very well received by trial investigator. As a result, we believe physicians have a more receptive view to the control arm that will lead to accelerated rates of enrollment. Once again, the BMT Tandem Meetings have proved to be an invaluable conference for us and we look forward to capitalizing on the positive momentum we generated in our interactions with the transplant community to complete enrollment of the SIERRA trial."

In addition, Dr. Sergio Giralt, Chief, Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center and Dr. Koen van Besien, Director, Stem Cell Transplant Program at Weill Cornell Medical Center highlighted trials from the Company’s CD33 program in the Company’s well attended product theater. Dr. Giralt highlighted the myeloablative potential of Actinium’s CD33 prior to a bone marrow transplant for patients with multiple myeloma that is being studied in the Actimab-M Phase 1 trial. Currently, Actimab-M is the only trial for a CD33 targeting agent and alpha-particle based therapy for multiple myeloma. Dr. van Besien also highlighted the myeloablative potential in patients with high-risk myelodysplastic syndrome (MDS) with a p53 genetic mutation that is expected to be studied in a planned Phase 2 trial for Actimab-MDS. The Actimab-MDS trial will be conducted with the MDS Clinical Research Consortium and this trial will be led by Dr. Gail Roboz, Director of the Leukemia Program and Professor of Medicine at Weill Cornell New-York Presbyterian Hospital and her colleagues at the Cleveland Clinic, Dana-Farber Cancer Institute, Johns Hopkins, MD Andersen Cancer Center, Moffitt Cancer Center and Weill Cornell.

Sandesh Seth, Actinium’s Executive Chairman said, "We were incredibly excited for Tandem this year as we were able to showcase our multi-disease, multi-target pipeline focused on myeloablation for the first time at this conference. There are great advances being made in the field of bone marrow transplant and we are excited to be at the forefront of improved myeloablation, which is a critical aspect of the patient’s journey and where we can make significant impact to patient access and outcomes. We came away from the conference incredibly excited by the opportunities that we see emerging in transplant and cell therapies that our technologies and growing pipeline are ideally suited for and also the opportunity to be the market leader providing superior conditioning in this growing area."

About BMT Tandem Meetings

Annually, the BMT Tandem Meetings are the largest gathering in North America of worldwide experts in blood and marrow transplant patient care, clinical investigation and laboratory research. Over 3,000 transplant physicians in over 500 transplant centers from >50 countries participate in the CIBMTR. The ASBMT has a membership of over 2,300 clinicians and researchers. By combining our meetings, we expect over 3,200 participants at next year’s meetings representing more than 50 countries, with approximately 20% coming from outside the United States.