Positive Clinical Trial and R&D Developments Creating Big Opportunities and Big Returns for Biotech Industry

Palm Beach, FL – (September 13, 2018) – Biotech and Big Pharma stocks have been performing very well of lat as the SPDR S&P Pharmaceuticals ETF has risen just about 15% since the beginning of 2018, compared with 8.5% gains for the S&P 500, and up 28% since its low in early May.  Small biotech stocks have earned a great deal of attention lately which is well deserved considering the Nasdaq Biotechnology Index has soared around 13.3% higher this year so far.  Increased investment in research and development is fueling advancements for some biotech companies such as solutions for neurodegenerative disease treatments and anticancer therapies. On pace to surpass $700 billion in revenue by 2025 according to Grand View Research, the biotech sector has become one of the most influential and lucrative forces in the medical market. FDA approvals are also pushing growth in this space as leaders aim to release innovative and unique therapies to battle the various types of diseases and conditions..  Active companies in the markets today include:  Moleculin Biotech, Inc. (NASDAQ:MBRX), Nemaura Medical Inc. (NASDAQ:NMRD), ChromaDex Corporation (NASDAQ:CDXC), Bausch Health Companies Inc. (NYSE:BHC) (TSX:BHC.TO), Geron Corporation (NASDAQ:GERN).


Moleculin Biotech, Inc. (NASDAQ:MBRX) BREAKING NEWS:  In the ongoing challenge to combat the almost always deadly brain cancers, namely Glioblastoma and melanoma metastasized to the brain, the pharmaceutical company Moleculin Biotechhas initiated a Phase 1 clinical trial of a new first-in-class cancer drug candidate, a small molecule compound discovered by Prof. Waldemar Priebe at  The University of Texas MD Anderson Cancer Center and known as WP1066. The compound has been shown in animal models to both inhibit an important cell signaling protein STAT3 that is involved in cell growth and proliferation and considered critical to tumor development, while also stimulating an immune response.  The first glioblastoma patient has received the initial doses of WP1066, which were apparently well tolerated, in the physician-sponsored IND (investigational new drug) study at MD Anderson Cancer Center.


Built from the chemical backbone of the active ingredient in propolis, a natural product of honey bees, WP1066 is the first anticancer agent with drug-like properties that consistently inhibits the activated form of STAT3 within cancer cells, a target that has been long-sought because of its broad range of tumor promoting effects.   Importantly, activated STAT3 supports the survival and proliferation of tumor cells, evasion of the immune response and metastasis to distant organs, as well as angiogenesis (growth of blood vessels) essential for tumor growth.  Activated STAT3 is not only connected with directly supporting tumor activity, but also suppressing the immune system, making this target even more important to cancer therapy.


With the support of extensive preclinical studies demonstrating high antitumor activity  and the critically important ability to cross the blood-brain barrier, WP1066 in this Phase 1 clinical trial will focus on treating aggressive brain tumors which all share a grim prognosis. The intent is to eventually treat up to 15 relapsed brain cancer patients over the next six to eight months. Phase 1 clinical trials typically focus on exploring safe and well tolerated doses, as well as evaluating initial signals of effectiveness. Each treatment is completed over three weeks.


“Treating the first brain tumor patient with WP1066 is the start of a very exciting and encouraging program for doctors treating the worst types of brain cancers. There has been very little progress in recent years toward improved therapies for glioblastoma and other aggressive primary or metastatic brain tumors.  WP1066 has shown extremely promising results based on animal studies where we have seen inhibition of tumor growth and improvements in survival,” said Dr. Sandra Silberman, a world-renowned oncologist and Moleculin’s Chief Medical Officer. “This is based on the fact that although STAT3 has long been identified as an important target for treating tumors, for years most efforts have focused on attempts to indirectly inhibit STAT3 from upstream signaling, not from within the cancer cell itself.  WP1066 appears to be unique in its ability in vitro and in animal models to consistently and directly inhibit the activated form of STAT3 and produce significant anticancer effects, including tumor growth inhibition and increased life span of treated animals.”


“This represents a major milestone for Moleculin,” commented Walter Klemp, Chairman and CEO.  “There has been tremendous enthusiasm within the oncology community for targeting STAT3, a key molecular hub of multiple pathways promoting tumor growth. Although the industry has been struggling to find a way to target STAT3, we at Moleculin believe that most of these efforts have been mechanistically misguided and ended in failure because their approach would ultimately be ineffective at adequately blocking the activation of STAT3 and lack the necessary drug-like properties to succeed.  The opportunity to test a unique STAT3 therapy in these patients is significant in supporting Moleculin’s mission to provide benefit for those who need new and better treatments.”  Read this and more news for Moleculin Biotech at:  http://www.marketnewsupdates.com/news/mbrx.html 

In other pharma and biotech developments and major influences in the markets of note this week: 


Nemaura Medical Inc. (NASDAQ:NMRD) closed up 30% on Wednesday at $2.86 with over 4.3 million shares traded by the market close. The company also announced reported data from an interim analysis of the first of a number of planned studies in support of a submission to the U.S Food & Drug Administration (“FDA”) for approval of its sugarBEAT® product. The interim results consisted of 25 patients, split approximately equally between Type I and Type II diabetics1. The study was conducted in a clinic setting, and blood samples were taken via a catheter every 15 minutes over a 12 hour period for 3 non-consecutive days, for a total of 75 patient days. Blood samples were measured using an Architect c8000 Laboratory Instrument. 9,371 data points were analysed in total, consisting of 4,630 and 4,741 paired data points analysed using 1-point and 2-point calibration respectively. The MARD (Mean Absolute Relative Deviation, @ 30%/30mg/dL) for the 1-point calibration was 12.19% (80% of all data), and for the 2-point calibration the MARD was 10.65% (88% of all data)). The results are in line with the company’s expectations, and compare favorably with competitor products.


ChromaDex Corporation (NASDAQ: CDXC) closed Wednesday up 15.43% at $4.04 per share. The company, an integrated, science-based, nutraceutical company devoted to improving the way people age with its flagship ingredient NIAGEN® and consumer product TRU NIAGEN®, today announced it will exhibit at Vitafoods Asia 2018. The sole active ingredient in TRU NIAGEN is nicotinamide riboside, a unique form of vitamin B3 clinically proven to safely increase one’s levels of NAD (nicotinamide adenine dinucleotide). Decreased NAD levels have been associated with many age-related changes in overall health. Vitafoods Asia will take place in Singapore from September 11-12—ChromaDex will exhibit at booth #M25 in the U.S.A. Pavilion. Attendance of Vitafoods is comprised of over 5000 manufacturers, distributors, and buyers from over 60 countries.


Bausch Health Companies Inc. (NYSE: BHC) (TSX:BHC) along with its wholly owned subsidiary, Salix Pharmaceuticals (“Salix”), which is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases, together with Salix’s licensors Cedars-Sinai Medical Center and Alfasigma SpA (collectively the “Salix Parties”), have agreed to resolve the outstanding intellectual property litigation with Actavis Laboratories FL, Inc. (“Actavis”), regarding XIFAXAN® (rifaximin) 550 mg tablets. Under the terms of the agreement, the Salix Parties will grant Actavis a non-exclusive license effective Jan. 1, 20281 to the Salix Parties’ intellectual property relating to XIFAXAN 550 mg tablets in the United States.


Geron Corporation (NASDAQ: GERN) came to a close at $5.97 up 3.47% with more than 6.8 million shares traded on the day. Geron Corporation operates as a biopharmaceutical company. The company supports the clinical stage development of imetelstat, a telomerase inhibitor for the treatment of hematologic myeloid malignancies. It has collaboration and license agreement with Janssen Biotech, Inc. to develop and commercialize imetelstat worldwide for indications in oncology, including hematologic myeloid malignancies and other human therapeutic uses.


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