Trump's Intentions to Streamline Drug-Approval Process Fueling Biotech Optimism

Tuesday, February 7, 2017 Drug News
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PALM BEACH, Florida, February 7, 2017 /PRNewswire/ --

With Trump sticking to his campaign promises and point of view,

coupled with his latest indications on the direction the industry is heading with concerns about drug prices, FDA approvals and regulations may be infusing somewhat of positive optimism in to the biotech/pharma industry.  Biotechnology and Pharmaceuticals
forging forward with developments of note in the markets include Organovo Holdings, Inc. (NASDAQ: ONVO), Q BioMed, Inc. (OTC: QBIO), Galena Biopharma, Inc. (NASDAQ: GALE), Pulmatrix, Inc. (NASDAQ: PULM) and Esperion Therapeutics, Inc. (NASDAQ: ESPR).

Q BioMed, Inc. (OTCQB: QBIO) has entered into an agreement with the Oklahoma Medical Research Foundation (OMRF) and the Rajiv Gandhi Centre for Biotechnology (RGCB) to develop a chemotherapeutic technology to treat liver cancer. The technology will utilize "uttroside B" and the compound's derivatives as a chemotherapeutic agent against hepatocellular carcinoma. The preclinical efficacy of uttroside B, a potent saponin, against liver cancer was recently demonstrated in a November 3, 2016 study published in Scientific Reports, a Nature journal.   Read this and more news for Vinergy Resources at:

The compound has been isolated and characterized from the leaves of Solanum nigrum Linn, a plant widely used in traditional medicine. In the Scientific Reports study, researchers showed that in animal models, uttroside B was ten times more cytotoxic to the HepG2 liver cancer cell line than the only drug currently approved by the Food and Drug Administration for liver cancer.

Uttroside B drastically shrunk tumors in mice bearing human liver cancer xenografts. In addition, in pre-clinical experiments uttroside B induced cytotoxicity in all liver cancer cell lines, irrespective of their hepatitis B virus status, while being non-toxic to normal immortalized hepatocytes.

Chemotherapeutic options for liver cancer are limited, and the prognosis of patients remains challenging. According to the Centers for Disease Control and Prevention, it is the second most common cause of cancer deaths worldwide, claiming approximately 750,000 lives each year. In the US, the American Cancer Society estimates that 39,000 people will be diagnosed with primary liver cancer in 2017 and that 27,000 will die from the disease this year.

In other industry related market performances and developments: 

Galena Biopharma, Inc. (NASDAQ: GALE), a biopharmaceutical company committed to the development and commercialization of hematology and oncology therapeutics that address unmet medical needs, on Monday announced the results from a meeting of the Data Safety Monitoring Board (DSMB) for the two investigator-sponsored (IST) combination clinical trials with NeuVax™ (nelipepimut-S) plus trastuzumab.  The trials are being run in breast cancer patients to assess the ability of the combination of trastuzumab and the HER2 vaccine nelipepimut-S (administered with the immunoadjuvant granulocyte macrophage-colony stimulating factor) to prevent recurrence in the adjuvant setting.

Organovo Holdings, Inc. (NASDAQ: ONVO) ("Organovo"), a three-dimensional biology company focused on delivering scientific and medical breakthroughs using its 3D bioprinting technology, in Late January announced a collaboration with Professor Melissa Little and the Murdoch Childrens Research Institute, The Royal Children's Hospital, Melbourne, Australia to develop an architecturally correct kidney for potential therapeutic applications.  The collaboration has been made possible by a generous gift from the Methuselah Foundation ("Methuselah") as part of its ongoing University 3D Bioprinter Program.

Pulmatrix, Inc. (NASDAQ: PULM) closed up over 29% at $4.98 on Monday trading over 18.9 Million shares by the market close.   Pulmatrix, Inc., announced last week that it has entered into a definitive agreement with several institutional investors to purchase an aggregate of approximately $3.33 million of shares of common stock in a registered direct offering.

Esperion Therapeutics, Inc. (NASDAQ: ESPR), the lipid management company focused on developing and commercializing convenient, complementary, cost-effective, once-daily, oral therapies for the treatment of patients with elevated low density lipoprotein cholesterol (LDL-C), announced in late January the completion of patient enrollment in the global pivotal Phase 3 long-term safety and tolerability study of bempedoic acid. Enrollment of this study was completed ahead of schedule in approximately 2,000 patients treated with bempedoic acid or placebo at high cardiovascular disease (CVD) risk with hypercholesterolemia whose LDL-C is not adequately controlled with current lipid-modifying therapies. Top-line results from this study are expected by Q2 2018.

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