Accelerated Clinical Trials Bridging Gateway to Latest Treatments for Cancer Patients

PALM BEACH, Florida, March 13, 2019 /PRNewswire/ --Cancer research has for years been steadily gaining ground on its way to managing, curing and even preventing the various forms of this insidious disease. Both public and private money continues to flow into the hands of researchers every year. The public has and it seems will continue to open their wallets and pocketbooks and try to do their part in eradicating cancer. In fact so has the government with the passage of the "Cancer Moonshot℠" which was signed into law in December 2016… it authorized $1.8 billion to fund cancer research for a seven-year period. The NIH, the National Cancer Institute says: "The goals of the Cancer Moonshot is ambitious - to accelerate cancer research to achieve a decade's worth of cancer research progress in 5 years."  Now that the money is in place, its time to put it to use and that requires research, which needs clinical trials which needs patients! The American Society of Clinical Oncology is aiding doctors to find and educate patients of the benefits of participating in a clinical trial. They say: "Doctors and scientists are always looking for better ways to care for patients with AML (and other forms of cancer). To make scientific advances, doctors create research studies involving volunteers, called clinical trials. In fact, every drug that is now approved by the U.S. Food and Drug Administration (FDA) was tested in clinical trials… Some clinical trials study new ways to relieve symptoms and side effects during treatment. Others study ways to manage the late effects that may happen a long time after treatment… There are also clinical trials studying ways to prevent cancer." Active biotech and pharma companies in the markets this week include Moleculin Biotech, Inc. (NASDAQ:MBRX), Seelos Therapeutics, Inc. (NASDAQ: SEEL, Elanco Animal Health Incorporated (NYSE: ELAN), Akebia Therapeutics, Inc. (NASDAQ: AKBA), Pfizer Inc. (NYSE: PFE).

The article continues by letting patients know that being in a clinical trial may give them access to promising drugs that are not yet available: "Many clinical trials focus on new treatments. Researchers want to learn if a new treatment is safe, effective, and possibly better than the treatment doctors use now. These types of studies evaluate new drugs, different combinations of existing treatments, new approaches to radiation therapy or surgery, and new methods of treatment. Patients who participate in clinical trials can be some of the first to get a treatment before it is available to the public."

Moleculin Biotech, Inc. (NASDAQ:MBRX) BREAKING NEWS:  Moleculin Biotech, a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced that it has submitted a request for Fast Track Designation with the US Food and Drug Administration (FDA) for its drug, Annamycin, for the treatment of relapsed or refractory acute myeloid leukemia (AML).

"Now that we have some traction in our clinical trials of Annamycin for the treatment of relapsed or refractory AML," commented Walter Klemp, Moleculin's Chairman and CEO, "we believe it is appropriate to request Fast Track designation for Annamycin.  Importantly, this is a valuable first step in ultimately qualifying for Accelerated Approval and Priority Review."

A drug that receives Fast Track designation is eligible for some or all of the following:

- More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval

- More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers

- Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met

- Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.     

Read this and more news for MBRX at:  https://www.financialnewsmedia.com/news-mbrx/   

Other recent developments in the biotech industry include:

Seelos Therapeutics, Inc. (NASDAQ: SEEL) On March 7, the company,  a clinical-stage biopharmaceutical company, 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.

Elanco Animal Health Incorporated (NYSE: ELAN) this week announced that  it is now a fully independent company. The completion of Eli Lilly and Company's exchange offer completes the journey Elanco began in 2017 when its former parent company first announced the exploration of potential strategic alternatives for the 64-year-old animal health company. The exchange offer was 7.6x oversubscribed.

"This is a historic day for everyone at Elanco," said Jeff Simmons, Elanco president and chief executive officer. "It reflects our team's hard work over the past two years, the confidence that we have the right strategy and are successfully progressing the execution against it. With this milestone behind us, we look forward to a singular focus delivering innovative solutions and services for our customers – the farmers, veterinarians and pet owners that are central to our success. We welcome our new Elanco shareholders who join us and offer our appreciation to our customers, and Lilly for the decades of support."

Akebia Therapeutics, Inc. (NASDAQ: AKBA) this week announced positive top-line results from two phase 3 active-controlled pivotal studies evaluating vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), in Japanese subjects with anemia due to chronic kidney disease (CKD). These studies were conducted by Akebia's development and commercialization collaboration partner in Japan, Mitsubishi Tanabe Pharma Corporation (MTPC). Each study, one in non-dialysis dependent subjects and one in hemodialysis-dependent subjects, met its primary endpoint. In addition, results from two phase 3 single-arm studies conducted by MTPC in peritoneal dialysis subjects and hemodialysis subjects further support vadadustat's potential in these indications. MTPC expects to submit a Japanese New Drug Application in 2019.

Pfizer Inc. (NYSE: PFE) this week announced the United States (U.S.) Food and Drug Administration (FDA) has approved TRAZIMERA™ (trastuzumab-qyyp), a biosimilar to Herceptin^®(trastuzumab),for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

"This is an important milestone in the U.S. which both adds to our growing portfolio of oncology treatments and has the potential to improve access to cancer care," said Andy Schmeltz, Global President, Pfizer Oncology. "We are proud to be able to offer treatment options that can help address the diverse needs of patients."

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