Navigation Links
ACT Receives Positive Opinion for Orphan Drug Designation from European Medicines Agency for hESC-Derived RPE Cells for Treatment of Stargardt's Disease
Date:3/10/2011

MARLBOROUGH, Mass., March 10, 2011 /PRNewswire/ -- Advanced Cell Technology, Inc. (“ACT”; OTC Bulletin Board: ACTC), a leader in the field of regenerative medicine, announced today that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has announced a positive opinion of ACT's human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells for designation as an orphan medicinal product for the treatment of Stargardt's disease. This opinion will now be forwarded by the EMA to the European Commission for their adoption, which should follow in coming weeks.  This follows on the US Food & Drug Administration's granting of Orphan Drug Designation for the same program from ACT, last year.

"We are very pleased to receive this positive opinion for Orphan Drug Designation from the EMA for our hESC-derived RPE cells for the treatment of Stargardt's disease," said Gary Rabin, ACT's interim chairman and CEO. "There is currently no approved treatment for Stargardt's disease, and we are working diligently to move this European trial forward as quickly as possible."

Orphan Drug Designation by the European Commission provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union (EU). In addition to a 10-year period of marketing exclusivity in the EU after product approval, Orphan Drug Designation provides companies with scientific advice and regulatory assistance from the EMA during the product development phase, direct access to centralized marketing authorization, as well as reductions in certain fees associated with the application and approval process.

About Stargardt's Disease Stargardt's disease or Stargardt's Macular Dystrophy is a genetic disease that causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium (RPE).

About Advanced Cell Technology, Inc.Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking StatementsStatements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words "will," "believes," "plans," "anticipates," "expects," "estimates," and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the company's periodic reports, including the report on Form 10-K for the year ended December 31, 2009.  Forward-looking statements are based on the beliefs, opinions, and expectations of the company's management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the company's management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Company's clinical trials will be successful. Contact:Investors:CEOcast, Inc., James Young, 212-732-4300Press:ACT Corporate Communications, Bill Douglass, 646-450-3615or:Russo Partners, Martina Schwarzkopf, Ph.D., 212-845-4292
'/>"/>

SOURCE Advanced Cell Technology, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Mylans Matrix Receives FDA Approval Under PEPFAR for Zidovudine Tablets, 100 mg
2. Everist Genomics Laboratory Receives Approval From U.S. Regulatory Authorities For High Complexity Clinical Testing
3. EMD Serono Receives Complete Response Letter From FDA on Cladribine Tablets New Drug Application
4. Rensselaer professor Daniel Lewis receives NSF CAREER Award
5. Pacific Shore Holdings, Inc. Receives Symbol Change Approval From FINRA
6. Boston College receives W.M. Keck Foundation funding for nanoscale optical microscope
7. CMU Receives $1.2 Million NIH Grant To Develop Ethics, Policy Recommendations for Post-Conflict, Post-Disaster DNA ID Practices
8. Dr. Stefan Strauf of physics at Stevens receives NSF CAREER Award for quantum research
9. Onyx Pharmaceuticals Receives Fast Track Designation for Carfilzomib; Company Initiates Rolling NDA Submission for Accelerated Approval
10. Arteriocyte Receives FDA Approval to Move Forward with Critical Limb Ischemia Trial
11. 3SBio Inc. Receives SFDA Approval for TPIAO Label Extension for the Treatment of ITP
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/22/2016)... June 22, 2016  According to Kalorama Information, ... sequencing (NGS) market include significant efforts in automation ... More accessible and affordable sequencers, say the healthcare ... for consumables including sample prep materials.  The healthcare ... Sample Preparation for Next Generation Sequencing (NGS) , ...
(Date:6/22/2016)...   ViaCyte, Inc. , a privately-held regenerative medicine ... therapy for the treatment of diabetes in clinical-stage development, ... ISSCR 2016, the Global Stem Cell Event, is taking ... San Francisco.    ... , Focus Session: Tools for Basic and Applied Stem ...
(Date:6/22/2016)... DIEGO , June 22, 2016  Mesa ... has developed a testing platform designed specifically for ... formation of their scientific advisory board (SAB). Approved ... directors, the SAB is chartered to advise on ... disease assay platform. Led by Dr. Steve ...
(Date:6/21/2016)... , China , June 22, 2016 ... Phase 2 clinical trial for its novel patch product ... (p=0.023) and clinically meaningful pain relief against placebo. Conducted ... States , the trial enrolled 146 patients with ... (1) analgesia against placebo at week-1 (p=0.024), (2) greater ...
Breaking Biology Technology:
(Date:6/2/2016)... 2016 The Department of Transport Management ... 44 million US Dollar project, for the , ... Personalization, Enrolment, and IT Infrastructure , to ... and implementation of Identity Management Solutions. Numerous renowned international vendors ... Decatur was selected for the most compliant and ...
(Date:6/2/2016)... 2, 2016 Perimeter Surveillance & ... Systems, Physical Infrastructure, Support & Other Service  ... offers comprehensive analysis of the global Border ... generate revenues of $17.98 billion in 2016. ... a leader in software and hardware technologies for advanced ...
(Date:5/24/2016)... Ampronix facilitates superior patient care by providing unparalleled technology to leaders of ... the latest premium product recently added to the range of products distributed by Ampronix. ... ... ... Medical Display- Ampronix News ...
Breaking Biology News(10 mins):