Paramount Developments Crucial for Advancing Clinical Trials Targeting Cancer Treatments

Palm Beach, FL – (February 5, 2018) – The biotech drug industry, with encouragement from the Food and Drug Administration (FDA), is advancing efforts to modernize clinical trials, streamlining the process of figuring out whether a treatment actually works.  “Clinical trials are getting more complex and increasing amounts of data are being collected,” says Steve Cutler, chief operating officer of clinical research organization ICON. “We need better approaches and we need to apply our current systems and technology better in order to meet the challenges posed by this – such as increasing numbers of patient subgroups, difficulties in finding those patients, and trials in rare diseases and orphan drugs becoming more common.”  Advances in genetic testing now allow physicians and researchers to offer methods of identifying and treating cancer that were not considered, or even understood, not that long ago.  Based on recent advancements and developments, it is an exciting time in the world of cancer treatment and doctors are now discussing new treatment options with patients who had little hope just a few years ago.   Active biotech and pharma companies in the markets this week include Moleculin Biotech, Inc. (NASDAQ:MBRX), MacroGenics, Inc. (NASDAQ: MGNX), Novelion Therapeutics Inc. (NASDAQ: NVLN), Clovis Oncology, Inc. (NASDAQ: CLVS), Pfizer Inc. (NYSE: PFE).


According to a new report recently published, research projects that the Clinical Trials market size will grow from USD $6.43 Billion in 2017 to USD $9.02 Billion by 2023, at an estimated CAGR of 5.8%. The base year considered for the study is 2017, and the market size is projected from 2018 to 2023. Clinical trials market now witnesses a paradigm shift.  The report continues with “developing countries also offer faster means; which is triggering major pharmaceutical companies to direct their investment in these regions. Apart from this, stringent regulations and tight R&D budgets in the pharma-biotech industry are also forcing companies to move to east.”


Moleculin Biotech, Inc. (NASDAQ:MBRX) BREAKING NEWS:  Moleculin Biotech, a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced it has received approval to begin clinical trials in Poland for its STAT3 inhibitor, WP1220, for the topical treatment of Cutaneous T-Cell Lymphoma (“CTCL”).


“This marks an important milestone for Moleculin.  We now have three unique drug candidates in four ongoing clinical trials for the potential treatment of rare and difficult cancers, ” commented Walter Klemp, Moleculin’s Chairman and CEO.  “We are committed to the strategy of what we call ‘multiple shots on goal,’ and this latest approval to begin trials means we now have three distinctly different therapies in clinical trials for the potential treatment of rare and difficult cancers.”


Dr. Don Picker, Moleculin’s Chief Science Officer, added, “CTCL is a potentially deadly form of skin cancer involving skin lesions that often have high levels of activated STAT3 (p-STAT3).  As a potent inhibitor of p-STAT3, we believe WP1220 may be ideally suited to treat these lesions through topical application, which is what this clinical trial is designed to evaluate.”


Dr. Malgorzata Sokolowska-Wojdylo, Dermatology Department Chair at the Medical University of Gdańsk in Poland, and the Principal Investigator running this clinical trial,  concluded, “There is a significant unmet need for improved topical therapies for CTCL, and we are excited to be the first clinic to evaluate this promising new drug in CTCL patients.”     Read this and more news for MBRX at  


Other recent developments in the biotech industry include:


MacroGenics, Inc. (NASDAQ: MGNX) recently announced positive results from SOPHIA, the Company’s Phase 3 clinical study of margetuximab in HER2-positive metastatic breast cancer patients. Margetuximab is an investigational immune-enhancing monoclonal antibody derived from the Company’s proprietary Fc Optimization technology platform. The SOPHIA clinical trial met the primary endpoint of prolongation of progression-free survival (PFS) in patients treated with the combination of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy. Patients in the margetuximab arm experienced a 24% risk reduction in PFS compared to patients in the trastuzumab arm (HR=0.76, p=0.033). Notably, approximately 85% of patients in the study were carriers of the CD16A (FcγRIIIa) 158F allele, which has been previously associated with diminished clinical response to HERCEPTIN and other antibodies. In this pre-specified subpopulation, patients in the margetuximab arm experienced a 32% risk reduction in PFS compared to patients in the trastuzumab arm (HR=0.68, p=0.005). Results of the SOPHIA study are being prepared for submission for publication and presentation later this year at a major scientific conference.


Novelion Therapeutics Inc. (NASDAQ: NVLN) recently announced that its subsidiary, Aegerion Pharmaceuticals, Inc. (“Aegerion”), has entered into an exclusive licensing agreement with Recordati Rare Diseases Inc. (“Recordati”) for the commercialization of JUXTAPID® (lomitapide) in Japan. The agreement includes exclusive rights in Japan for Recordati to commercialize JUXTAPID for the current approved indication, homozygous familial hypercholesterolemia (HoFH), and Aegerion grants Recordati an exclusive right of first negotiation for product commercialization in Japan of any potential new indications that may be developed by Aegerion.  “The licensing agreement for JUXTAPID in Japan is a positive step forward as we work to improve our near-term liquidity, reduce our operating expenses, and focus our efforts and resources with the goal of completing a comprehensive capital restructuring and creating a sustainable, cash-generating business,” said Ben Harshbarger, interim chief executive officer.


Clovis Oncology, Inc. (NASDAQ: CLVS) recently the company announced that the European Commission (EC) has approved the use of Rubraca® (rucaparib) for a second indication, as monotherapy for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. This expands rucaparib’s indication beyond its initial marketing authorization in Europe granted in May 2018 and with this label expansion, rucaparib is now available to patients regardless of their BRCA mutation status. Rucaparib was the first PARP inhibitor licensed for an ovarian cancer treatment indication in the EU and is now the first to be available for both treatment and maintenance treatment among eligible patients.  The EC authorization is based on data from the phase 3 ARIEL3 clinical trial, which found that rucaparib significantly improved progression-free survival in all ovarian cancer patient populations studied.


Pfizer Inc. (NYSE: PFE) this week announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending Vizimpro® (dacomitinib) 45 mg, as monotherapy, be granted marketing authorization in the European Union (EU) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations. The CHMP’s opinion will now be reviewed by the European Commission (EC).  Vizimpro was approved by the U.S. Food and Drug Administration (FDA) in 2018 for the first-line treatment of patients with metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. It was also recently approved in Japan for EGFR gene mutation-positive, inoperable or recurrent NSCLC.


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