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

Thursday, June 15, 2017 Clinical Trials News
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MarketNewsUpdates.com News Commentary

PALM BEACH, Florida, June 15, 2017 /PRNewswire/ --

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.

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