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Drug Developers Expecting Significant Clinical and Economic Benefits by Targeting Newest Drug Therapies

PALM BEACH, Florida, July 11, 2018 /PRNewswire/ -- News Commentary 

Clinical trial development is advancing ways to support sponsors and partnerships as biotech and pharmaceutical companies race to find, develop and deliver immuno-oncology (IO) therapies to the growing number of patients who await them. The biotech and big pharma industries are paying attention to the fact that over 3.65 million people every year are reaching retirement age in the U.S. not expecting to slow down until at least 2029. As American "baby boomers" reach the golden retirement age, the impact of the aging population is expected to drive national healthcare expenditures as well as company revenues much higher. According to the Centers for Medicare and Medicaid Services, in 2016, U.S. healthcare expenditures topped $3.4 trillion; this is $10,348 per person, and the figure is expected to grow 5.5% annually through 2026. The White House has promised reforms in the health care sector, such as changing the bidding process for drugs and shortening the FDA approval process causing an uptick in clinical trial activities and advanced drug therapy developments. Active companies in the markets today include: Moleculin Biotech, Inc. (NASDAQ: MBRX), Celgene Corporation (NASDAQ: CELG), Acceleron Pharma Inc. (NASDAQ: XLRN), BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX), MediciNova, Inc. (NASDAQ: MNOV).

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 formed Moleculin Australia Pty. Ltd., a wholly-owned subsidiary to oversee preclinical development in Australia.

"The Australian government provides a very aggressive incentive for research and development carried out in their country," commented Walter Klemp, Chairman and CEO of Moleculin. "For companies like Moleculin with less than $20,000,000 AUD group turnover, it can amount to a rebate of up to 43.5% of qualified R&D expenditures. Having an Australian subsidiary provides a great opportunity to speed up preclinical development and reduce the overall cost of our continued drug development efforts." Read this and more news for Moleculin Biotech at:

In other pharma and biotech developments in the markets: 

Celgene Corporation (NASDAQ: CELG) and Acceleron Pharma Inc. (NASDAQ: XLRN) this week announced results from a phase III, randomized, double-blind, multi-center clinical study (BELIEVE). Luspatercept achieved a highly statistically significant improvement in the primary endpoint of erythroid response, which was defined as at least a 33 percent reduction from baseline in red blood cell (RBC) transfusion burden with a reduction of at least 2 units during the protocol-defined period of 12 consecutive weeks, from week 13 to week 24, compared to placebo. BELIEVE evaluated the efficacy and safety of luspatercept plus best supportive care versus placebo plus best supportive care in adults with transfusion-dependent beta-thalassemia.

Celgene Corporation (NASDAQ: CELG) also announced this week that the Phase III IMpassion130 study, which was sponsored by Roche, met its co-primary endpoint of progression-free survival (PFS). This is the first phase III study to demonstrate a statistically significant PFS improvement in first-line metastatic or unresectable locally advanced triple negative breast cancer (TNBC), a type of breast cancer with high unmet need. Results demonstrated that the investigational combination of TECENTRIQ® (atezolizumab) plus ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) compared to ABRAXANE® monotherapy, as an initial (first-line) treatment, significantly reduced the risk of disease worsening or death (PFS) in patients with metastatic or unresectable locally advanced TNBC in the intention-to-treat (ITT) and PD-L1 positive populations.

BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX), a pharmaceutical company focused on the development and commercialization of treatments for rare diseases, recently announced that the Company has reached agreement on the design of a Phase 3 trial and regulatory requirements for marketing authorization of BCX7353 for Hereditary Angioedema ("HAE") with the Pharmaceuticals and Medical Devices Agency ("PMDA") in Japan. The Phase 3 trial design agreed upon for Japan, APeX-J, is a randomized, placebo-controlled double-blind trial of 24 weeks duration with a 28-week safety extension. Approximately 24 Japanese subjects with HAE will be enrolled. The APeX-J trial design closely follows the design of APeX-2, a Phase 3 clinical trial being conducted in the U.S., Canada and European countries. APeX-J tests the same dose levels of BCX7353 as in APeX-2, 110 mg daily and 150 mg daily, and the endpoints are identical to those in APeX-2. Data from the APeX-J and APeX-2 trials will be combined for regulatory submission in Japan.

MediciNova, Inc. (NASDAQ: MNOV), a biopharmaceutical company this week announced clinical data from ad-hoc subgroup analyses of MediciNova's completed clinical trial of MN-166 (ibudilast) in ALS (amyotrophic lateral sclerosis), which was conducted at Carolinas HealthCare System's Neuromuscular/ALS-MDA Center at Carolinas HealthCare System Neurosciences Institute. The ad-hoc subgroup analyses include data from (1) the "Early ALS subgroup" which is 31 subjects who had either bulbar onset or upper limb onset out of a total of 49 subjects without non-invasive ventilation in the full analysis set and (2) the "Early ALS + NIV subgroup" which is 39 subjects who had either bulbar onset or upper limb onset out of a total of 67 subjects with and without non-invasive ventilation in the full analysis set.

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