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Expansion of Global Clinical Trials for Treating an Array of Rare Diseases Boosting Market Growth

 [PRESSWIRE] PALM BEACH, Florida, June 15, 2017 --Clinical Trials for orphan drugs have shown tremendous potential in diagnosis and treatment of cancer with an increase in indications to treat an array of different diseases such as lymphoma, leukemia, myeloma, and others to boost the market growth potential for biotechs and pharmaceutical companies alike.

Orphan Drugs Market report, published by Allied Market Research, forecasts that the global market was valued at $106 billion in 2015 and is expected to garner $169 billion by 2022, registering a CAGR of 6.8% during the forecast period 2016 - 2022. Biotechnology and pharmaceutical companies with developments of note in the market today include: Moleculin Biotech, Inc., (NASDAQ: MBRX), Epizyme, Inc. (NASDAQ: EPZM), NeuroDerm Ltd. (NASDAQ: NDRM), Valeant Pharmaceuticals International, Inc. (NYSE: VRX), Omeros Corporation (NASDAQ: OMER).

Moleculin Biotech, Inc., (NASDAQ: MBRX), a preclinical 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 M.D. Anderson Cancer Center, today announced it has asked its contract research organization (CRO), Theradex Systems, Inc., to expand its engagement to include clinical sites in Poland for Moleculin's planned Phase I/II clinical trial of Annamycin for the treatment of relapsed or refractory acute myeloid leukemia (AML). Read this and more news for MBRX at http://www.marketnewsupdates.com/news/mbrx.html

"We have been working on ways to increase our rate of patient accrual once we start our planned clinical trial for Annamycin," commented Walter Klemp, Chairman and CEO of Moleculin, "And we have identified several promising sites in Poland. By expanding our engagement with Theradex, we help ensure tight coordination of clinical activity between the US and Poland."

Mr. Klemp continued: "If our IND is permitted, which must happen for clinical trials to begin, we intend to hit the ground running, and we believe Poland improves that capability. AML patients in Poland have less access to clinical trials than those in the US, which should make it easier for us to recruit relapsed or refractory AML patients who have received a fewer number of prior failed treatments and, as a result, may be less resistant to future treatments, and/or whose general health is less severely compromised. Work is already under way to identify a lead European Principal Investigator and to recruit the most appropriate clinical sites for the expansion."

In other biotech and pharmaceutical related developments and market activity this week: 

Epizyme, Inc. (NASDAQ: EPZM) closed up over 10% on Wednesday at $12.35 trading over 6.3 Million shares by the market close. Epizyme this week announced positive interim efficacy data from the company's ongoing Phase 2 clinical trial of tazemetostat, a first-in-class, oral EZH2 inhibitor, as a single-agent treatment for relapsed or refractory patients with follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL) grouped by EZH2 mutational status. The data were presented today during a plenary session at the International Conference on Malignant Lymphoma (ICML), which is being held June 14-17, 2017 in Lugano, Switzerland.

NeuroDerm Ltd. (NASDAQ: NDRM) closed up over 15% on Wednesday at $28.75 trading over 900,000 shares by the market close. NDRM was also up slightly in after hours market trading as well. The Company recently reported final data from trial 006. Trial 006 was an international open label, blinded rater, phase II study of ND0612H, NeuroDerm's high dose continuous, subcutaneously delivered levodopa/carbidopa (LD/CD) liquid formulation, in patients with advanced Parkinson's disease. In March 2017, NeuroDerm announced that a preliminary analysis of trial 006 demonstrated that the trial successfully met its primary, key secondary and additional secondary endpoints, with many patients experiencing a complete reduction of OFF-time to zero.

Valeant Pharmaceuticals International, Inc. (NYSE: VRX) closed even on the day on Wednesday at $12.46 trading over 8.3 Million shares by the market close. Valeant Pharmaceuticals recently announced it has entered into an agreement to sell its iNova Pharmaceuticals ("iNova") business to a company jointly owned by funds advised and managed by Pacific Equity Partners and The Carlyle Group for $930 million in cash. "The sale of iNova is part of the company's ongoing efforts to both simplify our operating model and strengthen our balance sheet," said Joseph C. Papa, Chairman and Chief Executive Officer, Valeant. "We will continue to evaluate opportunities that will enable us to deliver on our commitments and unlock value for shareholders."

Omeros Corporation (NASDAQ: OMER) closed up over 12% on Wednesday at $21.97 trading over 3.3 Million shares by the market close and was up slightly in after hours trading as well. Omeros Corporation announced this week that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to OMS721 for the treatment of Immunoglobulin A (IgA) nephropathy. OMS721 is Omeros' lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system. Breakthrough therapy designation was granted based on data from Omeros' Phase 2 clinical trial evaluating OMS721 in patients with IgA nephropathy and other kidney diseases.

DISCLAIMER:  MarketNewsUpdates.com (MNU) is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. MNU is NOT affiliated in any manner with any company mentioned herein. MNU and its affiliated companies are a news dissemination solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. MNU's market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. All material included herein is republished content and details which were previously disseminated by the companies mentioned in this release. MNU is not liable for any investment decisions by its readers or subscribers. Investors are cautioned that they may lose all or a portion of their investment when investing in stocks. For current services performed MNU has been compensated three thousand nine hundred dollars for news coverage of the current press release issued by Moleculin Biotech, Inc. by the company. MNU HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.

This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company's annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and MNU undertakes no obligation to update such statements.

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Category: 
Business and Finance
Date: 
Thursday, June 15, 2017
Categories: 
Medical