Positive Clinical Trial Developments Advance Forward for Biotech Sector Heading Into the New Year

Tuesday, December 5, 2017 Clinical Trials News
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PALM BEACH, Florida, December 5, 2017 /PRNewswire/ --

A string

of late-stage drug clinical trials are showing more than positive promise for a completely new generation of prevention drugs, anti-cancer drug candidates, new drug therapies and so much more which could hit the market as early as next year. It's an
emerging new world for pharmaceutical and biotechnology companies and it's a realm where science is trying to develop landmark medicines that cure cancer, hepatitis and other life-threatening illnesses. Over the past few years, biotech stocks have trounced the performance of the S&P 500 as the number of new drugs launched by biotech companies and more diseases than ever before can now be treated. As Republicans move closer to passing the Senate's tax bill, investors in biotech will remain focused on the possibility of a lower tax rate for repatriation of funds. The prospect of large and small biotech companies bringing cash back to the U.S. may spur some highly anticipated deals in a space that has been tracking this year to the lowest volume of transactions since 2013, according to data compiled by Bloomberg. Active in market today includes: Moleculin Biotech, Inc. (NASDAQ: MBRX), Cyclacel Pharmaceuticals Inc. (NASDAQ: CYCC), BeiGene Ltd. (NASDAQ: BGNE), Ohr Pharmaceutical Inc. (NASDAQ: OHRP), Eli Lily and Company (NYSE: LLY).

Moleculin Biotech, Inc. (NASDAQ: MBRX), 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"), announced the physician-sponsored Investigational New Drug ("IND") application for a Phase I trial of Moleculin's drug WP1066 in patients with recurrent malignant glioma and brain metastasis from melanoma has been allowed by the US Food and Drug Administration ("FDA"). "We are so pleased to now have a second drug enter the clinical stage," commented Walter Klemp, Chairman and CEO of Moleculin. "We believe WP1066 represents a new class of anticancer drugs able to fight tumors on two fronts by directly inhibiting cell signaling supporting tumor activity, and independently stimulating a natural immune response. This constitutes a new approach to treating brain tumors and tumor metastasis to the brain. Read this and more news for Moleculin Biotech at:http://www.marketnewsupdates.com/news/mbrx.html   Mr. Klemp concluded, "Since the discovery of WP1066 at MD Anderson by Prof. Waldemar Priebe, it has now been studied by many independent groups and is widely recognized as a potent inhibitor of the activated form of a protein called STAT3, which has been implicated in many difficult to treat tumors, including brain tumors. Animal studies have shown that inhibition of STAT3 directly blocks tumor proliferation and its survival, while most importantly boosting the immune system's ability to fight cancer. We finally have our first opportunity for a clinical proof of concept and confirmation of promising preclinical activity." This IND was sponsored by Dr. Amy Heimberger, who will serve as the principal investigator for the Phase I trial at MD Anderson Cancer Center to evaluate safety and efficacy. Details about the trial can be viewed on http://www.clinicaltrials.gov.    In other biotech developments stock performance of note in the markets: 

Cyclacel Pharmaceuticals Inc. (NASDAQ: CYCC) closed up over 9% on Monday at $2.15 on over 4.8 million shares traded by the market close and was also up in afterhours trading. Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical company using cell cycle, transcriptional regulation and DNA damage response biology to develop innovative, targeted medicines for cancer and other proliferative diseases. Cyclacel's transcriptional regulation program is evaluating CYC065, a CDK inhibitor, in patients with advanced cancers. The DNA damage response program is evaluating a sequential regimen of sapacitabine and seliciclib, a CDK inhibitor, in patients with BRCA positive, advanced solid cancers. Cyclacel's strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a pipeline of novel drug candidates.

BeiGene Ltd. (NASDAQ: BGNE) closed Monday up over 16% with over 1.3 million shares traded by the market close. BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. The company also announced it will webcast an analyst and investor event being held at the 59th American Society of Hematology (ASH) Annual Meeting to discuss updated data and the development program for its BTK inhibitor zanubrutinib (BGB-3111). ASH will take place December 9-12, 2017 in Atlanta, GA. Dial-In Numbers: 1-844-461-9930 or 1-478-219-0535 (US), 400-682-8609 or 800-870-0169 (China), 852-30114522 (Hong Kong), 65-66221010, 61-282239773, or 1-478-219-0535 (International) - Conference ID Number: 9086588

Ohr Pharmaceutical Inc. (NASDAQ: OHRP) closed up over 10% on Monday at $1.41 with more than 12 million shares traded by the market close and was up over 2% in afterhours trading. Ohr Pharmaceutical is a clinical-stage pharmaceutical company developing novel therapies for ophthalmic diseases. The company's lead drug candidate, Squalamine lactate ophthalmic solution, 0.2% (also known as OHR-102), is currently being studied using an eye drop formulation in an ongoing clinical trial for the treatment of the wet form of age-related macular degeneration. In addition, Ohr has a sustained-release micro fabricated micro-particle ocular drug delivery platform technology.

Eli Lily and Company (NYSE: LLY) closed up slightly on Monday with over 4.2 million shares traded by the market close. Last week, the company announced that the U.S. Food and Drug Administration (FDA) has approved TaltzŪ (ixekizumab) injection 80 mg/mL for the treatment of adults with active psoriatic arthritis (PsA).1 Taltz was first approved by the FDA in March 2016 for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.1 "PsA is a chronic, progressive and painful form of inflammatory arthritis that impacts approximately 1.6 million Americans living with the disease," said Christi Shaw, President, Lilly Bio-Medicines. "We are proud to offer a new treatment option that can provide improvements in joint symptoms for these patients, further demonstrating Lilly's overall commitment to immunology."

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