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Cancer Biology Clinical Research Seeking Answers at Cellular Level

PALM BEACH, Florida, March 26, 2019 /CNW/ -- Research for the cure for cancer has become this generation's version of President John F. Kennedy's May 25, 1961 proclamation to "Landing a man on the Moon and returning him safely". Much money and effort has been invested in this struggle, and as a result, there are more and more clinical trials and raw research, on attacking all forms of this disease. There are links on the internet, informing doctors, researchers and patients of ongoing clinical trials for every manifestation. Such sites as The National Cancer Institute at the National Institutes of Health or American Society of Clinical Oncology, which list active clinical trials in Breast Cancer, Childhood Cancers, Colorectal Cancer, Leukemia, Lung Cancer, Lymphoma, Metastatic Cancer, Pancreatic Cancer and Prostate Cancer. The Cancer.gov site also discussed that below each of the above clinical trials, there is a biology that is common to them all. Their article "Why Research on Cancer Biology Is Critical to Progress against the Disease - Research on the biology of cancer starts with the simplest of questions: What is — and isn't — normal? " The article goes on to says that: "To understand how cancer develops and progresses, researchers first need to investigate the biological differences between normal cells and cancer cells. This work focuses on the mechanisms that underlie fundamental processes such as cell growth, the transformation of normal cells to cancer cells, and the spread, or metastasis, of cancer cells.  Active biotech and pharma companies in the markets this week include Moleculin Biotech, Inc. (NASDAQ:MBRX), Seelos Therapeutics, Inc. (NASDAQ: SEEL), Bristol-Myers Squibb Company (NYSE: BMY), Catalyst Pharmaceuticals, Inc. (NASDAQ: CPRX), ChemoCentryx, Inc. (NASDAQ: CCXI).

Knowledge gained from such studies deepens our understanding of cancer and produces insights that could lead to the development of new clinical interventions. For example, studies of cell signaling pathways in normal cells and cancer cells have contributed greatly to our knowledge about the disease, revealing molecular alterations that are shared among different types of cancer and pointing to possible strategies for treatment. The last few decades of basic research in cancer biology have created a broad base of knowledge that has been critical to progress against the disease. In fact, many advances in the prevention, diagnosis, and treatment of cancer would not have occurred without the knowledge that has come from investigating basic questions about the biology of cancer.

Moleculin Biotech, Inc. (NASDAQ:MBRX) BREAKING NEWS:  Moleculin Biotech today announced positive interim safety and efficacy data from two ongoing open label, single arm Phase 1/2 studies of Annamycin.  In the first study, being conducted in the US, four patients have completed treatment at 100 mg/m2 with no significant adverse events related to Annamycin, and the study will now proceed to the next higher dose of 120 mg/m2. The second trial, taking place in Poland, started at a 120 mg/m2 dose of Annamycin and has treated three patients. The first patient treated in that trial received a single course of Annamycin and his bone marrow blasts have reduced from 60% to 11%. Our principal investigator considers this response sufficient for the patient to proceed to consolidation therapy, with the goal of receiving a potentially curative bone marrow transplant. To date in Poland, one patient experienced grade 2 mucositis (which resolved to grade 1 within 2 days) and no other adverse events related to Annamycin have been reported.  Trial results for the other two patients treated in Poland will not be known until the second quarter of this year.

"We are very pleased to have completed the treatment of patients in cohort 1 of the US trial and move to the next higher dose," commented Walter Klemp, Moleculin's Chairman and CEO.  "In Poland, we are pleased to have such a positive response at the starting dose level in this trial. Of course the response of a single patient doesn't necessarily predict the outcome of the trial, but this is a great way to begin and it's consistent with our expectations for Annamycin."

Mr. Klemp continued: "One of the advantages we believe Annamycin will offer is a lack of cardiotoxicity.  We have seen no evidence of cardiotoxicity in any of the patients treated thus far.  We intend to advance the clinical study of Annamycin with the goal of ultimately demonstrating the drug's safety and effectiveness to support regulatory approval in the US and European Union." 

Dr. Robert Shepard, Moleculin's Chief Medical Officer for Annamycin added: "A prior clinical trial for Annamycin in acute leukemia demonstrated activity at its Maximum Tolerable Dose of 150 mg/m2, so we are pleased for the US trial to move to the next higher dose in cohort 2  of 120 mg/m2. In Poland, we consider reducing bone marrow blasts for Patient 1 down to 11% with a single course of Annamycin to be very encouraging. Of course, significant additional study is necessary to definitively demonstrate causality."

"We have begun a second course of Annamycin as a consolidation phase for Patient 1," commented Dr. Lidia Gil, Principal Investigator in the Polish Annamycin clinical trial.  "Considering that this patient was refractory to standard of care induction therapy, I am very pleased to see that Annamycin appears to be showing activity.  While this is considered a 'Partial Response', I believe it's enough of a reduction to serve as a 'bridge to transplant' for this patient.  Importantly, with the first course of Annamycin, no toxicities have been observed that would limit continued dosing with Annamycin." Read this and more news for MBRX athttps://www.financialnewsmedia.com/news-mbrx/   

Other recent developments in the biotech industry include:

Seelos Therapeutics, Inc. (NASDAQ: SEEL) a clinical-stage biopharmaceutical company, recently announced that it has acquired an exclusive license to intellectual property owned by The Regents of the University of California (The UC Regents) pertaining to a technology that was created by researchers at the University of California, Los Angeles (UCLA). Such technology relates to a family of rationally-designed peptide inhibitors that target the aggregation of alpha-synuclein (α-synuclein). Seelos plans to study this initial approach in Parkinson's disease (PD) and will further evaluate the potential clinical approach in other disorders affecting the central nervous system (CNS). This new program will be known as SLS-007. Pre-clinical data provide supportive evidence to slow progression – an early sign of disease-modifying potential in PD.

Bristol-Myers Squibb Company (NYSE: BMY) On March 25, 2019, the Board of Directors sent an open letter to the Company's shareholders regarding the previously announced definitive merger agreement with Celgene Corporation (CELG). In addition to its March 19 investor presentation, the Company today also made available on Bristol-Myers Squibb's website at www.bestofbiopharma.com and later today will file with the Securities and Exchange Commission (SEC) an investor presentation providing an overview of Bristol-Myers Squibb's ability to derive value from Celgene's pipeline and a Fact Sheet providing additional detail on key benefits of the transaction.

Catalyst Pharmaceuticals, Inc. (NASDAQ: CPRX) a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, recently  reported financial results for the fourth quarter and year-ended December 31, 2018 and provided a corporate update. "2018 was a transformational year for Catalyst with the approval of Firdapse® (amifampridine phosphate) tablets, the first and only evidence-based, FDA approved treatment for patients with Lambert-Eaton myasthenic syndrome or LEMS. With this approval, all adult LEMS patients will now have affordable access to Firdapse," said Patrick J. McEnany, Chairman and Chief Executive Officer of Catalyst Pharmaceuticals.

ChemoCentryx, Inc. (NASDAQ: CCXI) and Vifor Fresenius Medical Care Renal Pharma Ltd., a company of Vifor Pharma Group, recently announced that in light of the upcoming availability of data from the pivotal Phase III ADVOCATE trial – the largest controlled trial in active anti-neutrophil cytoplasmic antibody associated vasculitis (ANCA-associated vasculitis) – they have decided to withdraw the application for Conditional Marketing Authorization (CMA) of avacopan for the treatment of ANCA-associated vasculitis based on Phase II data. Efforts will now be exclusively directed to file integrated regulatory submissions in 2020 with the European Medicines Agency (EMA) and United States Food and Drug Administration (FDA) for full (unconditional) marketing approval, after the planned release of topline data from the Phase III ADVOCATE clinical trial anticipated already in the fourth quarter of 2019.

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