On February 12, 2018 Lipocine reported to have presented its Corporate presentation (Press release, Lipocine, DEC 12, 2018, View Source [SID1234523947]).

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On February 12, 2018 MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage biotechnology company focused on the development of antibody-based products to address unmet medical needs in the treatment of cancer, reported positive interim results from the Company’s ongoing Phase 1 trial evaluating MVT-5873 in combination with standard of care chemotherapy in patients newly diagnosed with pancreatic and other CA19-9 positive malignancies (Press release, MabVax, FEB 12, 2018, View Source [SID1234523919]). At the dose tested, all six patients in the cohort had meaningful reductions in tumor volume by RECIST.

In the Phase 1 study, MabVax’s MVT-5873, a fully human antibody, was given in combination with nab-paclitaxel and gemcitabine to patients newly diagnosed with CA19-9 positive pancreatic cancer. MVT-5873 at a dose of 0.125 mg/kg when added to first-line chemotherapy was generally well tolerated by all subjects. The Company reported that all six patients had measurable tumor reductions, with four patients meeting the criteria for partial response (PR) and two patients meeting the criteria for stable disease (SD). These results help confirm results reported from a group of patients treated earlier. Patient CA19-9 levels, which are a prognostic indicator of the disease state, were markedly reduced in all subjects with this combination therapy. The Company plans to enroll additional patients at this dose to further explore safety and potential response.

"We are highly encouraged by the continued positive response across all of the initial patients at this dose of MVT-5873. We are enrolling additional patients at this dose level to confirm our early clinical results with a goal to determine if these clinically meaningful initial results can continue to be replicated in a larger patient population. With additional confirmatory data, we could establish the potential of combining MVT-5873 with first line therapy in very difficult to treat cancer patients," commented David Hansen, MabVax’s President and Chief Executive Officer.

This Phase 1 clinical trial is an open-label, multi-center nonrandomized study evaluating the safety and recommended Phase 2 dose of MVT-5873 in combination with a standard of care chemotherapy in subjects with pancreatic and other CA19-9 positive malignancies. Secondary objectives include evaluating tumor response rate by RECIST 1.1, duration of response, and to determine pharmacokinetics. This study utilizes a conventional 3+3 design to identify the recommended Phase 2 dose. Dr. Eileen O’Reilly, Associate Director of the David M. Rubenstein Center for Pancreatic Cancer Research, attending physician, member at Memorial Sloan Kettering Cancer Center and Professor of Medicine at Weill Cornell Medical College is the lead investigator in the MVT-5873 Phase 1 clinical trial.

For additional information about the Phase 1 MVT-5873 clinical trial, please visit clinicaltrials.gov, and reference Identifier NCT 02672917.

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On February 12, 2018 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address liver and inflammatory diseases, reported that pre-clinical studies show Namodenoson’s novel mechanism of action which entails de-regulation of 3 key signaling pathways which mediate the etiology and pathology of NAFLD/NASH and are responsible for the anti-inflammatory and anti-fibrogenic effect in the liver (Press release, Can-Fite BioPharma, FEB 12, 2018, View Source [SID1234524644]).

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Pre-clinical studies were conducted in hepato-stellate cells in vitro and in an experimental NASH CCL4 model, showing that in both systems, the molecular mechanism of action of Namodenoson was conferred by decreased expression levels of the signaling protein phosphoinositol-3-phosphate (PI3K) which controls 3 downstream signal transduction pathways, the Wnt, NF-kB and α-SMA, which control liver inflammation and liver fibrosis. The detailed data is scheduled to be presented at the 2018 International Liver Congress (ILC), which is the annual meeting of the European Association for the Study of the Liver (EASL) (View Source).

The Company is currently conducting a Phase II trial with its drug candidate Namodenoson for the treatment of 60 patients with non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). 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. Can-Fite’s 12-week study has been designed by leading Key Opinion Leaders in the area of NASH and liver diseases in the US including the company CAB members, Dr. Scott Friedman, Chief of the Division of Liver Diseases at the Icahn School of Medicine at Mount Sinai in New York; Dr. Arun Sanayal, Professor of Medicine, Physiology and Molecular Pathology at Virginia Commonwealth University School of Medicine; Dr. Rifaat Safadi, Head of the Liver Unit, Gastroenterology and Liver Diseases, Division of Medicine at Hadassah Medical Center and Dr. Stephen A. Harrison, the Medical Director of Pinnacle Clinical Research.

Namodenoson has been tested in over 100 subjects with other liver diseases, with clinical data suggesting a very favorable safety profile.

"We believe that the anti-inflammatory and anti-fibrogenic effects of Namodenoson, together with the favorable safety profile to date make it a promising drug candidate for the treatment of NAFLD/NASH," stated Prof. Rifaat Safadi.

About NAFLD/NASH

NAFLD is characterized by excess fat accumulation in the form of triglycerides (steatosis) in the liver. According to a study published in Hepatology, an estimated 17%-33% of the population in the U.S. has NAFLD, with a higher prevalence in people with type II diabetes. Incidence is increasing based on rising obesity rates. NAFLD includes a range of liver diseases, with NASH being the more advanced form, manifesting as hepatic injury and inflammation. According to the NIH, the incidence of NASH in the U.S. is believed to affect 2-5% of the population. The spectrum of NAFLDs resembles alcoholic liver disease; however, they occur in people who drink little or no alcohol. If untreated, NASH can lead to cirrhosis and liver cancer. By 2025, the addressable pharmaceutical market for NASH is estimated to reach $35-40 billion.

About Namodenoson (CF102)

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 is believed to account for the excellent safety profile of the drug. Can-Fite has received Orphan Drug Designation for Namodenoson in Europe and the U.S., as well as Fast Track Status in the U.S. as a second line treatment for hepatocellular carcinoma

On February 12, 2018 Athersys, Inc. (Nasdaq:ATHX) reported that it will release its year-end 2017 financial results at approximately 4:00 PM Eastern Time on Tuesday, March 13, 2018, and will host a conference call shortly thereafter at 4:30 PM Eastern Time to review the results (Press release, Athersys, FEB 12, 2018, View Source [SID1234523906]). Gil Van Bokkelen, Chairman and Chief Executive Officer, and William (B.J.) Lehmann, President and Chief Operating Officer, will host the call as follows:

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Date March 13, 2018
Time 4:30 p.m. (Eastern Time)
Telephone access: US and Canada (800) 273-1254
Telephone access: International (973) 638-3440
Access code 8898346
Live webcast www.athersys.com under Investors section
A replay will be available for on-demand listening shortly after the completion of the call until 11:59 PM Eastern Time on March 27, 2018 at the aforementioned URL, or by dialing (800) 585-8367 or (855) 859-2056 in the U.S. and Canada, or from abroad (404) 537-3406, and entering access code 8898346.

On February 12, 2018 Actinium Pharmaceuticals, Inc. (NYSE American:ATNM) ("Actinium" or "the Company") reported that an Investigational New Drug (IND) application has been submitted with the U.S. Food and Drug Administration (FDA) for Actimab-A in combination with CLAG-M for relapsed or refractory Acute Myeloid Leukemia (AML) patients (Press release, Actinium Pharmaceuticals, FEB 12, 2018, View Source [SID1234523904]). The planned Phase 1 trial studying Actimab-A in combination with CLAG-M will be an investigator initiated trial conducted at the Medical College of Wisconsin in a Phase 1, dose escalation study led by principal investigator Dr. Ehab Atallah in collaboration with Dr. Sameem Abedin. CLAG-M, a salvage chemotherapy regimen consisting of cladribine, cytarabine, and filgrastim, with mitoxantrone, is designed to induce remission in AML patients who are refractory to or have relapsed after standard induction therapy.

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Dr. Mark Berger, Actinium’s Chief Medical Officer said, "CLAG-M has become a widely used regimen for patients that is the standard of care at many institutions across the U.S. based on its ability to produce remissions in patients in relapse. By utilizing Actimab-A with CLAG-M, we expect to leverage Actimab-A’s potency and minimal extramedullary toxicities to derive synergies when used in combination with other active AML drugs. This important Phase 1 study will assess safety of the combination and determine an appropriate dose level for future studies. In future studies, we believe that this exciting combination could increase remission rates in relapsed patients. We also expect to use the Actimab-A CLAG-M combination regimen to increase the rate of successful stem cell transplant in relapsed patients, via improved myeloablation with the combination regimen. We look forward to work with Dr. Atallah and his colleagues at the Medical College of Wisconsin."

Actinium will host a conference call on Tuesday, February 13, 2018 at 4:30 PM ET that will be led by Dr. Mark Berger, Actinium’s Chief Medical Officer, and Dr. Atallah.

Webcast Registration:
View Source
U.S. Participant Dial-in: (646) 402-9440
U.S./Canada Toll Free Dial-in: (855) 698-6739
Conference ID: 2540

Sandesh Seth, Actinium’s Chairman and CEO said, "The advantageous properties of our CD33 targeting ARC or Antibody Radio-Conjugate have enabled us to expand our CD33 Program from a single indication to the only multi-disease program in the industry. In addition to the Actimab-A trial in newly diagnosed older AML, we have the only CD33 targeting agent in multiple myeloma via the Actimab-M trial. We are also exploring its use in targeted myeloablation in high-risk MDS with Dr. Roboz and the MDS Clinical Research Consortium via the planned Actimab-MDS trial. We are excited to now be studying the combination with CLAG-M for a large relapsed, refractory AML patient population with high unmet needs. Our intent is to further improve our positioning as the best in class CD33 program with applications as a therapeutic, myeloablative agent, and also the synergistic value of adding internalized radiation as a therapeutic modality to chemotherapy and other treatment approaches. In doing so, we intend to maximize the value of the program to a great number of potential partners and collaborators."

About Actimab-A

Actimab-A is Actinium’s lead drug candidate from its CD33 program and is an Antibody Radio-Conjugate (ARC) that is comprised of the CD33 targeting antibody lintuzumab and actinium-225, an alpha-emitting radioisotope. Actimab-A is currently being studied in Phase 2 clinical trial in patients that are newly diagnosed with AML who are over the age of 60 that are ineligible for intense chemotherapy, also known as unfit patients. Actimab-A has been granted Orphan Drug Designation for newly diagnosed AML in patients 60 and above by the U.S. Food and Drug Administration and the European Medicines Agency. The Company expects to complete patient enrollment of the Phase 2 trial in the first half of 2018 and report top line data results in the second half of 2018. The Company is also developing Actimab-M and Actimab-MDS, which are also CD33 actinium-225 ARCs. Actimab-M is being studied in a Phase 1 investigator-initiated trial for patients with refractory multiple myeloma. The Phase 1 Actimab-M trial is expected to complete enrollment and report top line data in the second half of 2018. Actimab-MDS is expected to begin a Phase 2 clinical trial in the second half of 2018 following a pre-IND meeting with the FDA in the first half of 2018. Actimab-MDS is intended to bridge patients with high-risk myelodysplastic syndrome (MDS) that have a p53 genetic mutation to a bone marrow transplant via targeted myeloablation. Actimab-A is a second-generation therapy from the Company’s CD33 Program, which was developed at Memorial Sloan Kettering Cancer Center and has now been studied in over 100 patients in four clinical trials.