Moleculin Expands Leukemia Development Portfolio with Immuno-Stimulating STAT3 Inhibitor

On January 10, 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 it has expanded the Company’s development pipeline for the treatment of acute myeloid leukemia ("AML") with an immuno-stimulating STAT3 inhibitor (Press release, Moleculin, JAN 10, 2018, View Source [SID1234523052]).

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"Leading experts in the treatment of AML, Dr. Jorge Cortes and Dr. Sanjay Awasthi have now asked us to expand our clinical research to include WP1066, our immuno-stimulating agent and STAT3 inhibitor, to increase therapeutic options for AML patients," commented Walter Klemp, Chairman and CEO of Moleculin. "This would potentially be complementary and synergistic with Annamycin and existing first line treatments and could position us as a leader in the advancement of leukemia treatments."

Dr. Sanjay Awasthi, Professor of the Department of Internal Medicine, Division of Hematology & Oncology, Texas Tech University Health Sciences Center and Medical Director, Southwest Cancer Center Lubbock, Texas, added, "The apparent ability in pre-clinical trials of WP1066 to stimulate the patient’s natural immune response and simultaneously inducing tumor cell death by inhibiting the activated form of STAT3 is highly promising and unique. Importantly, based on current scientific findings, such properties should be extremely valuable in developing improved treatments for AML patients and expanding their therapeutic options.

"We are clearly excited to see what Moleculin’s Annamycin can do for relapsed or refractory AML patients in the Company’s recently launched clinical trial," continued Dr. Awasthi, "thus given the potential for an even broader arsenal of AML drugs, we are encouraging Moleculin to expand their AML clinical research to include this novel immuno-stimulating STAT3 inhibitor drug candidate."

Another noted AML expert, Dr. Jorge Cortes, is also encouraging Moleculin’s clinical expansion, commenting: "AML appears to be associated with a significant increase in the activation of STAT3 and many of us in the AML clinical community have been eager to test the ability of a STAT3 inhibitor to treat AML patients. Part of the difficulty in pursuing this path has been finding a safe and effective STAT3 inhibitor and, if successful, WP1066 may have finally opened this pathway."

Mr. Klemp concluded: "Of course, our first priority will be to demonstrate single agent activity in both Annamycin and WP1066, but we see exploring the potential for synergistic effect as a longer-term opportunity as well."

Ritanserin is a novel DGKalpha inhibitor with unique selectivity and combinatorial effects against glioblastoma

Researchers have shown that ritanserin is a novel DGK-alpha inhibitor, with activity against glioblastoma (GBM) in vitro and in vivo. They have shown that it is synergistic with temozolomide chemotherapy and radiation against GBM cells. Furthermore, ritanserin has preferential cytotoxicity against mesenchymal GBM cells, a particularly treatment-resistant subset lacking any selective and effective therapies at this time.

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NanOlogy General Presentation (Jan 2018)

On January 9, 2018 NanOlogy presented General Presentation (Jan 2018) (Presentation, NanOlogy, JAN 9, 2018, View Source [SID1234523046])

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11 upcoming conferences and investor events

On January 9, 2018 4SC AG (4SC, FSE Prime Standard: VSC) reported its participation at upcoming conferences and investor events. 4SC’s management will be available for one-on-one meetings at these events (Press release, 4SC, JAN 9, 2018, View Source [SID1234523022]).

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4th annual Biotech and Money / Medtech and Money World Congress
5 February 2018
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BioCapital Europe 2018
6 February 2018
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7 February 2018
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2018 BIO CEO & Investor Conference
12 – 13 February 2018
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14 February 2018
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19 – 20 February 2018
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12th ODDO BHF German Conference (micro, small & mid cap)
21 – 22 February 2018
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28 February 2018
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1 March 2018
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Non Deal Roadshow: Luxembourg / Belgium
16 March 2018
Luxembourg / Belgium

Munich Stock Exchange Day 2018
17 March 2018
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Munich, Germany

Positive Results From a Multi-Center Analysis of Delcath PHP Therapy Published in Journal of Surgical Oncology

On January 9, 2018 Delcath Systems, Inc. (OTCQB:DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported that results of a multi-center retrospective analysis of Delcath’s PHP Therapy have been published in the peer-reviewed Journal of Surgical Oncology (Press release, Delcath Systems, JAN 9, 2018, View Source;p=RssLanding&cat=news&id=2325720 [SID1234523035]). 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 (Moffitt) in Tampa, FL and the University Hospital Southampton (UHS) in the United Kingdom. The retrospective analysis of outcomes in 51 patients with liver metastases from ocular melanoma represents the largest data set compilation on the use of PHP Therapy in this tumor type outside of a clinical trial setting.

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Patients in the study were treated at the two centers between December 2008 and October 2016. Patients received up to four PHP treatments at UHS and up to six PHP treatments at Moffitt. All patients received at least one PHP treatment, the median number of treatments per patient was two, and a total of 134 PHP treatments had been administered.

Results showed that of the 51 treated patients, 22 (43.1%) showed a partial response, 3 (5.9%) showed a complete response, and 17 (33.3%) had stable disease. The six-month overall and hepatic disease control rates were 64.7% and 70.6% respectively. Survival analysis showed median overall survival of 15.3 months at the time of data cut off. One year overall survival was 64.6%.

Safety analysis showed that 19 patients (37.5%) had Grade 3 or 4 non-hematologic toxicity. Cardiovascular toxicity was seen in 17.6% of patients, a rate comparable to the company’s prior Phase 3 study. Further to implementation of the Gen 2 filter along with prophylactic use of growth factors, severe neutropenia was seen in 16 (31.3%) patients as opposed to 60 (85.7%) patients in the prior Phase 3 trial. Most significantly, as compared to the prior Phase 3, there were no treatment related deaths. Researchers stated that PHP Therapy "can be safely employed in appropriately selected ocular melanoma patients in institutions with appropriate expertise."

The study authors further concluded that "results clearly demonstrate that PHP Therapy appears to be an effective means of obtaining rapid intrahepatic disease control, and is a sensible option in patients with predominant liver disease." Researchers said their results support the use of PHP Therapy in an integrated approach to the management of metastatic ocular melanoma, and looked to the company’s Phase 3 FOCUS Trial to further quantify the benefit and optimize treatment strategies for these patients.

Commenting on the announcement, Jennifer K. Simpson, Ph.D., President and CEO of Delcath Systems, said, "gathered over a period of 8 years, this retrospective two-center study represents the most robust data demonstrating a durable response, manageable side effects and a trend toward prolonged survival in this patient population since our prior Phase 3 trial. These data provide confidence that our Phase 3 FOCUS Trial can confirm these findings and produce the evidence necessary to support an application for a labeled indication in this tumor type."

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.