Why Clinical Trial Advantages And Regulatory Process In EU May Hold Advantages Over The U.S.

Why Clinical Trial Advantages And Regulatory Process In EU May Hold Advantages Over The U.S.

Palm Beach, FL – (January 9, 2018) – Numerous pharma/oncology companies have been conducting their clinical trials overseas for many years due to higher costs and regulations in the US. Among the EU nations though, Poland is regarded as one of the largest clinical trials markets in CEE/CIS and may be the best clinical trial site says Credevo, an online clinical research management system.  Its high levels of subject recruitment, high data quality and committed investigators and relatively low costs, Poland is an attractive location for clinical research with a relatively large population in comparison with neighboring countries. Moreover, there seems to be a greater motivation for patients in Poland to become involved in clinical trials, compared to mature Western European markets. This may just be because patient participating in trials in Poland usually have access to medical treatment of a higher level than is the case of standard care.  Active biotech and pharma companies in the markets this week include Moleculin Biotech, Inc. (NASDAQ:MBRX), Axsome Therapeutics (NASDAQ:AXSM), Moderna, Inc. (NASDAQ:MRNA), Pfizer Inc. (NYSE:PFE), La Jolla Pharmaceutical Company (NASDAQ:LJPC).

 

Additional reasons regarding Poland clinical trials and studies include specialized medical centers – There is considerable number of specialized medical centers clustered around main cities (e.g. Warszawa, Wrocław, Kraków, Poznań, Szczecin, Gdańsk, Lublin, Bydgoszcz, Rzeszów). These centers have well-qualified specialists and provide access to patients in all therapeutic areas, particularly oncology, rheumatology, cardiology and pediatrics.  Also it is noted Polish investigators are generally highly motivated to conduct clinical trials, as they can see the benefits in the work they do more than their colleagues in Western countries.

 

Moleculin Biotech, Inc. (NASDAQ:MBRX) BREAKING NEWS:  Moleculin Biotech, a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all 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 begun in Poland recruiting patients in the Company’s second clinical trial to study Annamycin for the treatment of relapsed and refractory adults with acute myeloid leukemia (“AML”).

 

“We are encouraged to see ready access to qualified patients in Poland,” commented Walter Klemp, Moleculin’s Chairman and CEO.  “Having now cleared the unique European approval process to ship Annamycin, which had delayed the start of the trial in Poland,  clinical supplies are now in country and ready to treat patients. The sites there have begun the patient screening and recruitment process.  Our expectation is that the fewer number of AML clinical trials in Poland as compared with the U.S. will give us an opportunity to complete the Phase 1 arm more quickly here.”    Read this and more news for MBRX athttps://www.financialnewsmedia.com/news-mbrx/   

 

Other recent developments in the biotech industry include:

 

Axsome Therapeutics (NASDAQ:AXSM) closed up over 29% on Tuesday at $8.88 trading over 25 Million shares by the market close.  Its average volume is slightly over 1.1 million.  Axsome Therapeutics, a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, this week announced that AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity, met the prespecified primary endpoint and significantly improved symptoms of depression in the ASCEND Phase 2 trial in major depressive disorder (MDD). The ASCEND study is a randomized, double-blind, active-controlled, multi-center, U.S. trial, in which 80 adult patients with confirmed moderate to severe MDD were treated either with AXS-05 (45 mg dextromethorphan/105 mg bupropion), or the active comparator bupropion (105 mg), twice daily for 6 weeks.

 

Moderna, Inc. (NASDAQ:MRNA), closed up over 4% on Tuesday at $16.95 trading over 1.8 Million shares by the market close.  Moderna is a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced recent updates to several of its immuno-oncology and rare disease programs and outlined its 2019-2020 corporate objectives. Moderna has 21 mRNA development candidates in its pipeline, with 11 programs now in clinical development.  “This year we are focused on making significant advances to our pipeline as we work to bring multiple programs into Phase 2 clinical trials, move programs within our rare disease portfolio toward the clinic and leverage our mRNA platform to create both new development candidates and potential new modalities where we believe there is an opportunity to develop therapies for a broad range of diseases,” said Stéphane Bancel, Moderna’s Chief Executive Officer.

 

Pfizer Inc. (NYSE:PFE) closed up on Tuesday at $43.43 trading over 18 Million shares by the market close. Pfizer recently announced the initiation of a Phase 2b/3 clinical trial for its oral JAK3 inhibitor, PF-06651600, for the treatment of patients with moderate to severe alopecia areata, a chronic autoimmune skin disease that causes hair loss on the scalp, face, or body, and currently has no approved therapies.  “We are proud to start this global pivotal Phase 2b/3 trial for PF-06651600 in patients with alopecia areata. We hope this potential treatment will be able to help patients who currently have limited treatment options,” said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. “Including our JAK3 program, Pfizer has several selective kinase programs in the clinic with studies spanning across rheumatology, gastrointestinal disorders, and medical dermatology, where we aspire to deliver potentially transformative medicines to those living with chronic autoimmune and inflammatory conditions.”

 

La Jolla Pharmaceutical Company (NASDAQ:LJPC) closed up over 4% on Tuesday at $5.45 trading over 7.7 Million shares by the market close.  Its average trading volume is slightly over 550,000. La Jolla is a leader in the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, this week highlighted recent corporate progress and key objectives. Recently the company highlighted its recent corporate progress and outlined its clear objectives and stated that as of December 31, 2018, La Jolla had approximately $172 million in cash and cash equivalents and no debt. In 2019, La Jolla expects that its net cash used in operating activities will be $89 million to $94 million.  Decision on GIAPREZA MAA by EMA Expected in June of 2019: La Jolla expects a decision on the GIAPREZA Marketing Authorisation Application (MAA) by the European Medicines Agency (EMA) in June of 2019.

 

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