CNS
Roeselare, Belgium
CNS
Roeselare, Belgium

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Patent
Cns | Date: 2015-08-21

Remote collaboration systems and methods may involve a server in communication with a network and a plurality of remote computers in communication with the network. The server may connect to the plurality of remote computers via the network. The server may generate a collaboration environment for each of the remote computers. The server may assign an access level from a plurality of access levels to each of the remote computers, the plurality of access levels including a view only access level and an edit access level. The server may provide secure access to a file to each of the remote computers at the access level assigned to each of the remote computers via the collaboration environment. The file can be remotely viewed by any of the remote computers having a view only access level and remotely viewed and remotely edited by any of the remote computers having an edit access level via the collaboration environment.


News Article | February 22, 2017
Site: www.PR.com

Returning to Central London for the 14th year, SMi’s Controlled Release Delivery conference will take place on the 3rd & 4th of April 2017. London, United Kingdom, February 22, 2017 --( Hear from Merck, Novartis, Janssen, Actelion, GSK, Boehringer Ingelheim and many more as they evaluate: generic drug development, biopharmaceutical approaches, oral bioavailability and parenteral drug delivery. Keynote addresses for Controlled Release Delivery 2017: René Holm, Head and Scientific Director, Liquids & Parenterals, from Janssen will be presenting on "Lipid suspensions - how, when and with what?" René will discuss: - What is a lipid based suspension and how could it look from a commercialisation perspective? - When can lipid based suspensions be used to improve the oral bioavailability? - How large a proportion of the compound needs to be solubilised in the lipid phase? - What excipients to use for lipid based formulation? Mark Wilson, Director, Technology Licensing, PTS from GlaxoSmithKline will be speaking on "The development and commercialisation of drug delivery systems Challenges and opportunities," where he will provide attendees with information on the following: - GSK’s experiences in developing technologies - The collaborative “open innovation” approach - Commercialisation challenges – finding the breakthrough application - Examples of successful development and exploitation projects - GSK’s approach to working with other organisations A full speaker line-up and detailed conference agenda is available to download online at www.controlledreleasedelivery.com/prcom. For those looking to attend, there is currently a £100 discount available which expires on 28th February 2017. Controlled Release Delivery Strengthening innovation and overcoming the challenging regulatory landscape 3rd & 4th April 2017 London, UK Sponsored by: Avanti Polar Lipids, Buchi, Data Detection Technologies, Precision NanoSystems and Sirius Analytical www.controlledreleasedelivery.com/prcom Contact Information: For all media enquiries contact Zoe Gale on Tel: +44 (0)20 7827 6032 / Email: zgale@smi-online.co.uk To register for the conference, visit www.controlledreleasedelivery.com/prcom or contact Ameenah Begum for group bookings on Tel: +44 (0)20 7827 6166 / Email: abegum@smi-online.co.uk To sponsor, speak or exhibit at the conference, contact Alia Malick on Tel: +44 (0)20 7827 6168 / Email: amalick@smi-online.co.uk About SMi Group: Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk London, United Kingdom, February 22, 2017 --( PR.com )-- The two day conference will provide attendees with 5+ hours of networking time, an exclusive post-conference workshop and 16 thought provoking presentations covering the topics of; innovations in drug delivery; nanoparticles, nanomedicine & QbD, CNS drug delivery and therapeutic applications.Hear from Merck, Novartis, Janssen, Actelion, GSK, Boehringer Ingelheim and many more as they evaluate: generic drug development, biopharmaceutical approaches, oral bioavailability and parenteral drug delivery.Keynote addresses for Controlled Release Delivery 2017:René Holm, Head and Scientific Director, Liquids & Parenterals, from Janssen will be presenting on "Lipid suspensions - how, when and with what?" René will discuss:- What is a lipid based suspension and how could it look from a commercialisation perspective?- When can lipid based suspensions be used to improve the oral bioavailability?- How large a proportion of the compound needs to be solubilised in the lipid phase?- What excipients to use for lipid based formulation?Mark Wilson, Director, Technology Licensing, PTS from GlaxoSmithKline will be speaking on "The development and commercialisation of drug delivery systems Challenges and opportunities," where he will provide attendees with information on the following:- GSK’s experiences in developing technologies- The collaborative “open innovation” approach- Commercialisation challenges – finding the breakthrough application- Examples of successful development and exploitation projects- GSK’s approach to working with other organisationsA full speaker line-up and detailed conference agenda is available to download online at www.controlledreleasedelivery.com/prcom. For those looking to attend, there is currently a £100 discount available which expires on 28th February 2017.Controlled Release DeliveryStrengthening innovation and overcoming the challenging regulatory landscape3rd & 4th April 2017London, UKSponsored by: Avanti Polar Lipids, Buchi, Data Detection Technologies, Precision NanoSystems and Sirius Analyticalwww.controlledreleasedelivery.com/prcomContact Information:For all media enquiries contact Zoe Gale on Tel: +44 (0)20 7827 6032 / Email: zgale@smi-online.co.ukTo register for the conference, visit www.controlledreleasedelivery.com/prcom or contact Ameenah Begum for group bookings on Tel: +44 (0)20 7827 6166 / Email: abegum@smi-online.co.ukTo sponsor, speak or exhibit at the conference, contact Alia Malick on Tel: +44 (0)20 7827 6168 / Email: amalick@smi-online.co.ukAbout SMi Group:Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk Click here to view the list of recent Press Releases from SMi Group


News Article | February 15, 2017
Site: globenewswire.com

EMERYVILLE, Calif., Feb. 15, 2017 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a pharmaceutical company developing therapies for the treatment of orphan and central nervous system (CNS) disorders, today announced that Michael P. Smith, Executive Vice President, Chief Financial Officer & Treasurer and Secretary, will conduct investor meetings at the RBC Capital Markets Healthcare Conference, taking place February 22-23, 2017, in New York, NY. About Zogenix Zogenix, Inc. (Nasdaq:ZGNX) is a pharmaceutical company committed to developing and commercializing CNS therapies that address specific clinical needs for people living with orphan and other CNS disorders who need innovative treatment alternatives to improve their daily functioning. Forward Looking Statements Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed" and similar expressions are intended to identify forward-looking statements. These statements are based on the company's current beliefs and expectations. These forward-looking statements include statements regarding the potential commercialization of ZX008; the timing of top-line results from the Phase 3 clinical trial of ZX008 in Dravet syndrome and other 2017 milestones; and the timing of any submission of a new drug application to the U.S. Food and Drug Administration or comparable market authorization filing in Europe. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: the uncertainties associated with the clinical development and regulatory approval of product candidates such as ZX008, including potential delays in the commencement, enrollment and completion of clinical trials; the potential that earlier clinical trials and studies may not be predictive of future results; Zogenix's reliance on third parties to conduct its clinical trials, enroll patients, manufacture its preclinical and clinical drug supplies and manufacture commercial supplies of its drug products, if approved; unexpected adverse side effects or inadequate therapeutic efficacy of ZX008 that could limit approval and/or commercialization, or that could result in recalls or product liability claims; Zogenix's ability to fully comply with numerous federal, state and local laws and regulatory requirements, as well as rules and regulations outside the United States, that apply to its product development activities; Fast Track designation may not result in an expedited regulatory review process; the potential for distraction of management related to the transition of management responsibilities; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.


News Article | March 3, 2017
Site: www.businesswire.com

SEATTLE--(BUSINESS WIRE)--Impel NeuroPharma, a Seattle-based clinical-stage biotechnology company developing first-in-class intranasal drug treatments, announced today the appointment of Timothy S. Nelson as Independent Director of the Board of Directors. Mr. Nelson has over 20 years of experience with drug delivery, medical devices and drug device combinations. Most recently, Mr. Nelson served as MAP Pharmaceuticals’ President and CEO and as a member of its Board of Directors from April 2005 until March 2013. MAP was acquired by Allergan for $960 million. During that time, Mr. Nelson led the company through its initial public offering and developed LEVADEX, an inhaled dihydroergotamine for migraine. Prior to MAP, he served as Senior Vice President of Commercial and Business Development at DURECT Corporation and has held various senior management positions with Medtronic, including Business Director of the Neurological Division for Europe, the Middle East and Africa, and as Manager of Drug Delivery Ventures. Mr. Nelson has served on several boards, including Chairman of the Board of Civitas, a private biopharmaceutical company focused on treating undermet medical needs in neurological indications from December 2013 to October 2014. The company was acquired by Acorda Therapeutics for $525 million that year. He also served on the Board of Directors of Surmodics, a public medical technology company, from February 2014 to March 2015. Mr. Nelson holds a Master’s degree in Management with distinction from the Kellogg Graduate School of Management at Northwestern University and a Bachelors in Chemical Engineering from the University of Minnesota. “We are very excited to bring Tim onto Impel’s Board of Directors. Tim brings a deep knowledge of both medical devices and pharmaceutical products that will help Impel drive clinical development of our drug-device combination products,” said John Hoekman, Impel’s Founder & CEO. “Impel is developing nasally administered products to treat migraine, Parkinson’s, and Alzheimer’s disease. Tim’s experience and leadership will help Impel advance these therapies through clinical testing and into the hands of patients.” “Impel’s unique, cutting-edge technology has the potential to make a substantial step forward in more effective delivery of drugs which can mean better outcomes for millions of patients who are underserved by existing therapies,” Mr. Nelson said. “I am very pleased to be able to contribute to Impel’s mission and growth.” Impel NeuroPharma’s POD™ nasal drug delivery platform is designed to deliver drugs to the upper nasal cavity for improved biodistribution. By delivering therapeutics to the upper nasal cavity, the POD nasal delivery platform takes advantage of the vascular rich olfactory region for improved bioavailability and has the potential to target the brain via the olfactory and trigeminal nerves. Delivery of therapeutically meaningful levels of drugs may allow for development of more effective drugs and expand the range of treatment options available to patients. Impel NeuroPharma, Inc. is a Seattle-based company developing intranasal drug treatments for central nervous system (CNS) disorders. Impel NeuroPharma has developed a novel drug delivery platform, the POD™ technology, that administers drug to the deep nasal cavity to improve the biodistribution of many drugs. Impel NeuroPharma’s proprietary (POD) device technology enables entirely new categories of drugs, including biologics, to be administered using a cost-effective, disposable, non-invasive intranasal drug delivery device. To learn more about Impel NeuroPharma please visit our website: http://impelnp.com/. NOTICE: This document contains certain forward-looking statements, including without limitation statements regarding Impel NeuroPharma, Inc.’s plans for future research and development activities. You are cautioned that such forward-looking statements are not guarantees of future performance and involve risks and uncertainties inherent to Impel’s business which could significantly affect expected results, including without limitation progress of drug development, ability to raise capital to fund drug development, clinical testing and regulatory approval, developments in raw material and personnel costs, and legislative, fiscal, and other regulatory measures. All forward-looking statements are qualified in their entirety by this cautionary statement, and Impel’s undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.


News Article | March 2, 2017
Site: www.prweb.com

ProMIS Neurosciences (“ProMIS” or the “Company”), a company focused on the discovery and development of precision treatments for neurodegenerative diseases, today announced the appointment of Anthony J. Giovinazzo, MBA, to its Board of Directors, effective immediately. “I first met Anthony over twenty years ago, working together on an Alzheimer’s diagnostics opportunity” stated Eugene Williams, ProMIS Executive Chairman. “He and I have been talking about a shared commitment to making a difference in Alzheimer’s for a long time. After the outstanding job that Anthony did at Cynapsus, for both Parkinson’s patients and shareholders, he has many alternatives. We are thrilled that he has chosen to apply his talents and energy to ProMIS”. Anthony Giovinazzo is currently President and CEO of Sunovion CNS Development Canada ULC. As President and CEO of Cynapsus Therapeutics from 2009 through 2016 he led the successful purchase of Cynapsus by Sunovion Pharmaceuticals, a member of the Dainipon Sumitomo Pharma group of Japan. At Cynapsus, Anthony led the successful development of APL 130277 (a sublingual strip of apomorphine) through to late stage Phase 3 studies and was responsible for Cynapsus up-listing from the TSX Venture exchange to the TSX and then the NASDAQ. “I am delighted to join the Board of Directors of ProMIS Neurosciences,” stated Mr. Giovinazzo. “Having devoted most of my career to the development and commercialization of therapies for neurodegenerative disease, I look forward to leveraging my experience to support the Company as it develops innovative, precision medicine therapeutics for Alzheimer’s disease and ALS”. About Anthony Giovinazzo, MBA. Anthony J. Giovinazzo has over thirty-eight years of professional experience. His first seven years were spent as an international corporate tax specialist primarily in multinational conglomerates. Over the subsequent eight years Anthony worked in Fortune 100 investment banking and private equity. For the last twenty-three years he worked exclusively on the discovery, development and commercialization of neurodegenerative disease therapeutics. His primary areas of focus have been Alzheimer’s, Parkinson’s and neuropathic pain. Since October 2016 he has been the President and CEO of Sunovion CNS Development Canada ULC., a successor company to Cynapsus Therapeutics Inc., which was purchased by Sunovion Pharmaceuticals Inc., a member of the Dainipon Sumitomo Pharma group of companies of Japan. He was President, CEO and a Director of Cynapsus Therapeutics Inc. from 2009 to 2016 and was one of the three original inventors and patent holders of the Cynapsus Parkinson’s focussed technology. Under his leadership the company successfully developed APL 130277 (a sublingual strip of apomorphine for OFF episodes) through to late stage Phase 3 studies. In addition, Anthony led the up-listing of Cynapsus from the TSX Venture exchange to the TSX and then the NASDAQ, attracting bulge bracket investment banks and some of the largest institutional life science investors in the USA. The sale of Cynapsus to Sunovion in 2016 resulted in a 120% premium to market price (CDN$841 million) via an all cash M&A transaction. Mr Giovinazzo is the co-author of several peer reviewed papers and author of several papers on strategic and financing issues in the biopharmaceutical industry. He was a finalist in the E&Y Entrepreneur of the Year (2014) for Ontario Canada. He is a Chartered Director and Audit Committee Certified, both from The Directors College, a degree granting affiliate of Mc Master University, Hamilton Canada. He also has completed the Leadership and Strategy in Pharmaceuticals and Biotech, in 2006 from Harvard Business School, Boston, MA; a Masters of Business Administration from IMD, Geneva Switzerland in 1986; Graduate Certificate Studies in Canadian Law Osgoode Hall Law School, York University, Toronto, in 1984; and his Bachelor of Arts in Economics and Accounting at McMaster University in 1978. The mission of ProMIS Neurosciences is to discover and develop precision medicine therapeutics for effective treatment of neurodegenerative diseases, in particular Alzheimer’s disease and ALS. ProMIS Neurosciences’ proprietary target discovery engine is based on the use of two, complementary techniques. The Company applies its thermodynamic, computational discovery platform—ProMIS™ and Collective Coordinates — to predict novel targets known as Disease Specific Epitopes (DSEs) on the molecular surface of misfolded proteins. Using this unique "precision medicine" approach, ProMIS Neurosciences is developing novel antibody therapeutics and specific companion diagnostics for Alzheimer’s disease and ALS. The company has also developed two proprietary technologies to specifically identify very low levels of misfolded proteins in a biological sample. In addition, ProMIS Neurosciences owns a portfolio of therapeutic and diagnostic patents relating to misfolded SOD1 in ALS, and currently has a preclinical monoclonal antibody therapeutic against this target. The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This information release may contain certain forward-looking information. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by statements herein, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on the Company's current beliefs as well as assumptions made by and information currently available to it as well as other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by the Company in its public securities filings, actual events may differ materially from current expectations. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. For further information please consult the Company's website at: http://www.promisneurosciences.com Like us on LinkedIn


BARCELONA, SPAIN and CAMBRIDGE, MA--(Marketwired - February 24, 2017) - Oryzon Genomics ( : ORY) (ISIN Code: ES0167733015), a public clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, today reported financial results for the fourth quarter of 2016 and provided an update on the Company's recent developments. The company successfully completed the Phase I/IIA clinical trial in acute leukemia of its epigenetic drug ORY-1001; data was presented at the ASH-2016 Conference in December in San Diego, providing a demonstration of biological proof of concept and allowing the characterization of the first clinical responses. These and other data contributed to the decision by our licensee Roche to start a new Phase I clinical trial in small cell lung cancer patients. Under the terms of the License Agreement, this clinical trial and all subsequent trials will be funded entirely by Roche. ORY-2001 has continued its satisfactory progression in the MAD phase of the Phase I clinical trial in healthy volunteers. ORY-2001 is the first ever Histone Demethylase inhibitor being explored in CNS disorders, with a particular emphasis in Alzheimer's disease and Multiple Sclerosis. This program should be Phase II ready in the first half of 2017. The company has continued its experimental work in preclinical models of Alzheimer's disease and other CNS indications and has done substantial advances in the characterization of the mechanism of action of ORY-2001 in the EAE Multiple Sclerosis model. This broadens the therapeutic indication's potential for the Clinical Development Plan of this drug. ORY-3001, the company's third LSD1 inhibitor, in preclinical development for the treatment of a non-oncological yet undisclosed orphan disease, continues its favorable progression through the regulatory tox. package. This program should be IND/CTA ready in the first half of 2017. Collaboration revenue was $0.03 million and $0.8 million for the last 3 and 12 months ended December 31, 2016, respectively, as compared to $0.9 million and $4.6 million for the last 3 and 12 months ended December 31, 2015 respectively. The period-over-period decreases reflect decreased recognition of deferred revenue from upfront payments and research and development revenue related to the Company's collaboration with Roche. Research and development (R&D) expenses were $1.7million and $5.5 million for the last 3 and 12 months ended December 31, 2016, respectively, as compared to $0.7 million and $4.1 million for the last 3 and 12 months ended December 31, 2015 respectively. The $1.0 million increase was driven primarily by accelerated R&D efforts in the ORY-2001 program. General and administrative expenses were $1.0 million and $5.0 million for the last 3 and 12 months ended December 31, 2016, respectively, as compared to $1.5 million and $4.6 million for the last 3 and 12 months ended December 31, 2015 respectively. This decrease is primarily due to the fact that during the fourth quarter of 2015 the company incurred in specific expenses related with the activities to list the company in the Spanish Stock market. Net loss was -$1.4 million and -$5.7 million for the last 3 and 12 months ended December 31, 2016 (-$0.20 and -$0.21 per share) respectively, compared to a net loss of -$0.7 million and -$1.1 million the last 3 and 12 months ended December 31, 2015 (-$0.03 and -$0.04 per share) respectively. Cash, cash equivalents and marketable securities were $28.7 million as of December 31, 2016, compared to $23.7 million as of December 31, 2015. Oryzon closed a tranche of Debt Funding round in 2016 of $16.6 million. Founded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company considered as the European champion in Epigenetics. The company has one of the strongest portfolios in the field and a clinical asset already partnered with Roche. Oryzon's LSD1 program is currently covered by + 20 patent families and has rendered two compounds in clinical trials. In addition, Oryzon has ongoing programs for developing inhibitors against other epigenetic targets. The company has a strong technological platform for biomarker identification and performs biomarker and target validation for a variety of malignant and neurodegenerative diseases. Oryzon's strategy is to develop first in class compounds against novel epigenetic targets through Phase II clinical trials, at which point it is decided on a case-by-case basis to either keep the development in-house or to partner or outlicense the compound for late stage development and commercialization. The company has offices in Barcelona and Cambridge, Massachusetts. For more information, visit www.oryzon.com. This communication contains forward-looking information and statements about Oryzon Genomics, S.A., including financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future operations, capital expenditures, synergies, products and services, and statements regarding future performance. Forward-looking statements are statements that are not historical facts and are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates" and similar expressions. Although Oryzon Genomics, S.A. believes that the expectations reflected in such forward-looking statements are reasonable, investors and holders of Oryzon Genomics, S.A. shares are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Oryzon Genomics, S.A., that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the documents sent by Oryzon Genomics, S.A. to the Comisión Nacional del Mercado de Valores, which are accessible to the public. Forward-looking statements are not guarantees of future performance. The auditors of Oryzon Genomics, S.A, have not reviewed them. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date they were made. All subsequent oral or written forward-looking statements attributable to Oryzon Genomics, S.A. or any of its members, directors, officers, employees or any persons acting on its behalf are expressly qualified in their entirety by the cautionary statement above. All forward-looking statements included herein are based on information available to Oryzon Genomics, S.A. on the date hereof. Except as required by applicable law, Oryzon Genomics, S.A. does not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. This press release is not an offer of securities for sale in the United States. The Company's securities may not be offered or sold in the United States absent registration or an exemption from registration. Any public offering of the Company's securities to be made in the United States will be made by means of a prospectus that may be obtained from the Company or the selling security holder, as applicable, that will contain detailed information about the Company and management, as well as financial statements.


HIGH POINT, N.C.--(BUSINESS WIRE)--High Point Clinical Trials Center announced that it has partnered with Verified Clinical Trials (VCT), the global clinical trials database registry, to insure the appropriate selection and qualification of subjects participating in their clinical trials at their North Carolina research facility. “We are extremely pleased to partner with Verified’s Global Clinical Trials Database Registry to ensure the safety of study participants and continue to provide the highest quality data for our clients,” says Dr. Lorraine M. Rusch, President of High Point Clinical Trials. “As a leading clinical research facility, it is our medical and quality mandate to use innovative technology such as VCT’s database to prevent the duplicate enrollment of clinical trial participants across multiple trials in different clinical research facilities across the country.” Duplicate enrollment of subjects (simultaneous enrollment in multiple clinical trials) has become a challenge for the biopharmaceutical sector, impacting clinical research programs across the industry. Verified Clinical Trials uses biometric fingerprint technology to register subjects and create a record of the highest clinical confidence. The result is an improvement in data quality and safety for study volunteers as it prevents duplicate enrollment in trials at facilities in the registry. “We are proud to welcome High Point Clinical Trials to our client base,” says Mitchell D. Efros, MD, FACS, CEO of Verified Clinical Trials. “This collaboration demonstrates their commitment to the highest possible quality of participant safety. Including their data in our registry will also significantly enhance the value of the registry to all our participants. Now research sponsors can have an even higher level of confidence in the data High Point Clinical Trials Center provides.” Originally, High Point Clinical Trials Center was founded by Dr. Adnan Mjalli in 2008. Our founder and staff bring extensive experience to this process as both as a sponsor and CRO. High Point Clinical Trials Center (HPCTC) has transformed into a dedicated clinical trial facility which specializes in the execution of Phase I-III clinical trials. In addition to early development studies, we conduct studies across a range of therapeutic indications including metabolic, respiratory and CNS in a pleasant and comfortable environment managed by caring and experienced staff. At the cutting edge of medical research, we also pride ourselves on our commitment to community care, with physicians volunteering around the community and around the world to provide medical access to patients in need. Verified Clinical Trials is a forward-thinking company developed by experts active in the clinical research community to proactively improve research subject safety and data quality in clinical research trials. Verified Clinical Trials halts duplicate enrollment in clinical trials and defines itself as the world’s leader in the field of database registries in clinical trial research. Verified Clinical Trials is the only clinical research database registry selected by the NIH to prevent duplicate enrollment in clinical trials. Verified Clinical Trials is designed specifically to enhance the quality of both early and late phase trials, and has the scalability to reach all sites nationally as well as on a global level.


The company will present a poster on February 24th 2017 BARCELONA, SPAIN and CAMBRIDGE, MA--(Marketwired - February 20, 2017) - Oryzon Genomics (ISIN Code: ES0167733015) ( : ORY), a public clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today that it will present new preclinical data of therapeutic activity in Multiple Sclerosis of ORY-2001, a novel epigenetic drug for the treatment of neurodegenerative diseases at the 2nd Annual Conference of the "Americas Committee for Treatment and Research in Multiple Sclerosis" (ACTRIMS) to be held in Orlando, Fl. USA on February 23-25. Dr. Tamara Maes, Vice President and Chief Scientific Officer of the Company, will present positive preclinical data that will expand those already presented at the ECTRIMS European Conference last September in London. The presentation will take place on Friday, February 24 at the symposium and present its poster from 12.30 to 14.00 local time with the poster entitled "ORY-2001 Reduces Lymphocyte Egress and Demyelination in Experimental Autoimmune Encephalomyelitis and Highlights the Epigenetic Axis in Multiple Sclerosis". Due to the communication policy established by the organization of this congress, Oryzon will give further details of the results obtained on the first business day after the presentation in the conference. ORY-2001 is a highly selective dual LSD1-MAOB inhibitor. The molecule, which focuses on cognitive decline and memory loss, has a good safety profile and therapeutic index in preclinical trials. In nontransgenic AD mouse models, long-term treatments with the drug demonstrated a marked cognitive improvement. The company has also recently presented data that supports the potential application of this experimental drug in other CNS neuroinflammatory disorders such as Multiple Sclerosis. LSD1 is an epigenetic modulator, which regulates histone methylation. Epigenetic approaches to modify the progression of various neurodegenerative diseases focus on producing changes in patterns of gene expression in neurons and also in glia cells and are of interest for the pharmaceutical industry. The Phase I trial with ORY-2001, initiated in early 2016 to determine its safety, tolerability and kinetics in healthy volunteers, will be completed in a few weeks. Shall the preliminary results be confirmed, Oryzon's clinical development plan contemplates the initiation of several Phase II studies later this year to assess its safety and efficacy in diseases such as Multiple Sclerosis, Alzheimer's and other neurodegenerative or neuroinflammatory diseases. Oryzon has a highly competitive and productive Epigenetic Platform centered in LSD1 with a first forerunner program licensed to Roche (ORY-1001/RG6016) that has recently finished Phase I/IIA in acute leukemia and that is currently being explored in an ongoing Phase I clinical trial in SCLC that validates scientifically and clinically the Platform. This Platform has so far produced two additional programs, one already in clinical development (ORY-2001) with multiple indication opportunities that is pioneering the Histone demethylases field in neurodegenerative disorders, the other is ORY-3001, a third epigenetic compound, also against LSD1, in preclinical development for a yet undisclosed non-oncological orphan indication. About Oryzon Founded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company considered as the European champion in Epigenetics. The company has one of the strongest portfolios in the field and a clinical asset already partnered with Roche. Oryzon's LSD1 program is currently covered by + 20 patent families and has rendered two compounds in clinical trials. In addition, Oryzon has ongoing programs for developing inhibitors against other epigenetic targets. The company has a strong technological platform for biomarker identification and performs biomarker and target validation for a variety of malignant and neurodegenerative diseases. Oryzon's strategy is to develop first in class compounds against novel epigenetic targets through Phase II clinical trials, at which point it is decided on a case-by-case basis to either keep the development in-house or to partner or outlicense the compound for late stage development and commercialization. The company has offices in Barcelona and Cambridge, Massachusetts. For more information, visit www.oryzon.com. FORWARD-LOOKING STATEMENTS This communication contains forward-looking information and statements about Oryzon Genomics, S.A., including financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future operations, capital expenditures, synergies, products and services, and statements regarding future performance. Forward-looking statements are statements that are not historical facts and are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates" and similar expressions. Although Oryzon Genomics, S.A. believes that the expectations reflected in such forward-looking statements are reasonable, investors and holders of Oryzon Genomics, S.A. shares are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Oryzon Genomics, S.A., that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the documents sent by Oryzon Genomics, S.A. to the Comisión Nacional del Mercado de Valores, which are accessible to the public. Forward-looking statements are not guarantees of future performance. The auditors of Oryzon Genomics, S.A, have not reviewed them. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date they were made. All subsequent oral or written forward-looking statements attributable to Oryzon Genomics, S.A. or any of its members, directors, officers, employees or any persons acting on its behalf are expressly qualified in their entirety by the cautionary statement above. All forward-looking statements included herein are based on information available to Oryzon Genomics, S.A. on the date hereof. Except as required by applicable law, Oryzon Genomics, S.A. does not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. This press release is not an offer of securities for sale in the United States. The Company's securities may not be offered or sold in the United States absent registration or an exemption from registration. Any public offering of the Company's securities to be made in the United States will be made by means of a prospectus that may be obtained from the Company or the selling security holder, as applicable, that will contain detailed information about the Company and management, as well as financial statements.


NEW YORK, March 01, 2017 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced its financial results for the fourth quarter and year ended December 31, 2016, and provided a corporate update. Intra-Cellular Therapies (the Company or ITCI) reported a net loss of $27.5 million, or $0.64 per share (basic and diluted), for the fourth quarter of 2016 compared to a net loss of $28.8 million, or $0.67 per share (basic and diluted), for the fourth quarter of 2015. The Company reported a net loss of $116.4 million, or $2.69 per share (basic and diluted), for the full year ended December 31, 2016 compared with a net loss of $104.8 million, or $2.91 per share (basic and diluted), for the full year ended December 31, 2015. Research and development (R&D) expenses for the fourth quarter of 2016 were $21.2 million, compared to $22.9 million for the fourth quarter of 2015. For the full year ended December 31, 2016, R&D expenses were $93.8 million, compared to $87.7 million for the full year ended December 31, 2015. The decrease for the quarter is primarily due to lower costs associated with the completion of the second Phase 3 clinical trial for lumateperone (also known as ITI-007) in patients with schizophrenia in the third quarter of 2016, offset in part by the costs of the Phase 3 clinical trials of lumateperone for the treatment of bipolar depression and agitation associated with dementia, including Alzheimer’s disease, and other clinical trials and increased manufacturing costs for lumateperone. The increase for the year is primarily due to an increase in manufacturing and labor related costs, offset in part by lower clinical trial related costs. There were decreased costs in 2016 for the first Phase 3 clinical trial for lumateperone in patients with schizophrenia that was completed in 2015. These lower costs were offset primarily by increased costs for the second Phase 3 clinical trial for lumateperone in patients with schizophrenia completed in the third quarter of 2016, along with the costs associated with the Phase 3 clinical trials of lumateperone for the treatment of bipolar depression and agitation associated with dementia, including Alzheimer’s disease, and other clinical trials. General and administrative (G&A) expenses were $7.0 million for the fourth quarter of 2016, compared to $6.5 million for the same period in 2015. For the full year ended December 31, 2016, G&A expenses were $24.8 million, compared to $18.2 million for the prior-year period. The increase in both periods is primarily the result of higher stock-based compensation expense and, to a lesser extent, professional fees, pre-commercialization activities and increased salaries. Cash and investments totaled $384.1 million at December 31, 2016, compared to $475.2 million at December 31, 2015. The Company expects that existing cash and investments of $384.1 million will be used primarily to advance the lumateperone development program, including to fund clinical trials of lumateperone in bipolar depression, behavioral disturbances in patients with dementia, depressive disorders and other lumateperone clinical trials and related clinical and non-clinical activities; to fund pre-commercial activities for lumateperone for the treatment of schizophrenia and, if lumateperone receives regulatory approval, initial commercialization efforts; to fund pre-clinical and clinical development of the Company’s ITI-007 long-acting injectable program; and to fund non-clinical activities including the continuation of manufacturing activities in connection with the development of lumateperone. Funds will also be used for other clinical and pre-clinical programs, including the Company’s phosphodiesterase (PDE) development activities. “Patients who suffer from neuropsychiatric and neurodegenerative disorders continue to be underserved by existing medications and we remain committed to developing innovative treatments that can provide broad efficacy without many of the safety and tolerability issues associated with current therapies,” said Dr. Sharon Mates, Chairman and CEO of ITCI. The Company will host a live conference call and webcast today at 8:30 AM Eastern Time to discuss the Company's financial results and provide a corporate update. The live webcast and subsequent replay may be accessed by visiting the Company's website at www.intracellulartherapies.com. Please connect to the Company's website at least 5-10 minutes prior to the live webcast to ensure adequate time for any necessary software download. Alternatively, please call 1-(844) 835-6563. (U.S.) or 1-(970) 315-3916 (international) to listen to the live conference call. The conference ID number for the live call is 72927263. Please dial in approximately 10 minutes prior to the call. Intra-Cellular Therapies is developing novel drugs for the treatment of neuropsychiatric and neurodegenerative diseases and diseases of the elderly, including Parkinson's and Alzheimer's disease. The Company is developing its lead drug candidate, lumateperone (also known as ITI-007), for the treatment of schizophrenia, bipolar disorder, behavioral disturbances in patients with dementia, including Alzheimer's disease, depression and other neuropsychiatric and neurological disorders. Lumateperone, a first-in-class molecule, is in Phase 3 clinical development for the treatment of schizophrenia, bipolar depression and agitation associated with dementia, including Alzheimer's disease. The Company is also utilizing its phosphodiesterase platform and other proprietary chemistry platforms to develop drugs for the treatment of CNS and other disorders. This news release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, our expected use of our cash, cash equivalents and investment securities; our beliefs about the extent to which the results of our clinical trials to date support an NDA filing for lumateperone for the treatment of schizophrenia; the time period in which we expect to provide an update on the status of our discussions with the FDA; our clinical and non-clinical development plans; the initiation, progress, timing and results of our clinical trials; the safety and efficacy of our product development candidates; our beliefs about the potential uses and benefits of lumateperone; our plans to present additional data on our development programs; our beliefs about unmet medical needs and our research and development efforts and plans under the caption "About Intra-Cellular Therapies." All such forward-looking statements are based on management's present expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These risks and uncertainties include but are not limited to the following: our current and planned clinical trials and other studies for lumateperone and for our other product candidates may not be successful or may take longer and be more costly than anticipated; product candidates that appeared promising in earlier research and clinical trials may not demonstrate safety and/or efficacy in larger-scale or later clinical trials; our proposals with respect to the regulatory path for our product candidates may not be acceptable to the FDA; our reliance on collaborative partners and other third parties for development of our product candidates; and the other risk factors detailed in our public filings with the Securities and Exchange Commission. All statements contained in this press release are made only as of the date of this press release, and we do not intend to update this information unless required by law. (1) The condensed consolidated statements of operations for the years ended December 31, 2016 and 2015 have been derived from the financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. (1) The condensed consolidated balance sheets at December 31, 2016 and 2015 have been derived from the financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.


News Article | March 1, 2017
Site: globenewswire.com

JSC “Grindeks” announces it has received the statement of the company’s Member of the Board Ibraim Muhtsi on his resignation from the position of Member of the Board on his own volition starting from 1 March 2017. Until further notice the Board of JSC “Grindeks” will consist of Chairman of the Board Juris Bundulis and Member of the Board, Chief Finance and Administrative Officer Janis Romanovskis. “Grindeks” is an international, vertically integrated pharmaceutical company. Main fields of action are research, development, manufacturing and sales of original products, generics and active pharmaceutical ingredients. The Group of “Grindeks” consists of five subsidiary companies in Latvia, Estonia, Russia and Slovakia as well as representative offices in 12 countries. “Grindeks” specializes in the heart and cardiovascular, CNS and anti-cancer medication therapeutic groups. A range of products covers a successful combination of original products and generics, with the original products Mildronate® and Ftorafur®. Currently “Grindeks” produces 23 active pharmaceutical ingredients. Products of the company are exported to 71 countries and its export comprises 91% of the total turnover. The key markets include the EU countries, Russia and other CIS countries, the U.S., Canada, Japan and Vietnam. To increase production capacity and develop infrastructure, the company has accomplished many significant investment projects, investing more than 90 million euros over the last 15 years.

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