Navigation Links
ACT Granted EU Orphan Medicinal Product Designation for hESC-Derived RPE Cells for Treatment of Stargardt's Disease
Date:6/27/2011

MARLBOROUGH, Mass., June 27, 2011 /PRNewswire/ -- Advanced Cell Technology, Inc. ("ACT"; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) has officially granted ACT's human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells designation as an orphan medicinal product for the treatment of Stargardt's Macular Dystrophy (SMD). This follows on the U.S. Food & Drug Administration's (FDA) granting of Orphan Drug Designation for the same program from the company, last year.

"It is very gratifying to receive approval for orphan drug status 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. "SMD, a juvenile degenerative retinal disease, affects between 80,000 to 100,000 patients in the U.S. and Europe, and there is currently no treatment available for SMD. We are working with European regulatory agencies to gain approval for the trial design we have proposed for the SMD clinical trial in Europe.  The initiation of our Phase 1/2 clinical trial for SMD in the U.S. is an important milestone, and we hope to be able to provide more good news to patients and our investors in the near future."

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 (less than 175,000 patients in total) 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, and reductions in certain fees associated with the application and approval process.

ACT announced recently the enrollment of the first patients in two clinical trials using hESC-derived RPE cells for the treatment of SMD and Dry Age-Related Macular Degeneration.

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 Statements

Statements 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, 2010.  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, 212-732-4300

Press:
ACT Corporate Communications, Bill Douglass, 646-450-3615
or:
Russo Partners, Martina Schwarzkopf, Ph.D., 212-845-4292


'/>"/>
SOURCE Advanced Cell Technology, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
2. Pharmion and MethylGene Announce U.S. Orphan Drug Designation Granted for MGCD0103 for the Treatment of Hodgkins Lymphoma
3. Advanced Life Sciences Announces ALS-357 Granted FDA Orphan Drug Designation for Metastatic Melanoma
4. Taxotere(R) (docetaxel) Granted FDA Approval to Treat Locally Advanced Head and Neck Cancer Prior to Chemoradiotherapy and Surgery
5. Aptivus(R) (tipranavir) Capsules Granted Full Approval by the U.S. FDA
6. Authorization for AGENDA Phase 3 Trial of Genasense(R) in Advanced Melanoma Granted by French Regulatory Agency
7. Emphasys Medical Granted Expedited Review From FDA for Zephyr(R) Endobronchial Valve
8. Pharmion and MethylGene Announce Orphan Drug Designation Granted by the European Medicines Agency (EMEA) for MGCD0103 for the Treatment of Acute Myelogenous Leukemia
9. Pharmion and MethylGene Announce U.S. Orphan Drug Designation Granted for MGCD0103 for the Treatment of Acute Myelogenous Leukemia
10. Inclusion of Six-Year Overall Survival Data in the Eloxatin(R) (oxaliplatin injection) Prescribing Information Granted FDA Priority Review
11. Multaq(R) (dronedarone) Granted FDA Priority Review for Patients with Atrial Fibrillation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/27/2016)... the necessity of health literacy within the technology advancement of diagnostic imaging. According to a ... majority of oncology patients undergo imaging screenings without understanding the nuanced risks associated with ... ... ... Diagnostic Imaging Ampronix ...
(Date:5/27/2016)... Israel , May 27, 2016 ... of the Dario™ Diabetes Management Tool, today announced that the ... at the Marcum MicroCap Conference being held June 1-2 in ... Micro Invitational, being held June 7-9 in Los ... Ben-David will discuss recent corporate and operational milestones, including the ...
(Date:5/27/2016)... According to the 2016 report, ... ambulatory blood pressure monitoring system market growth. With aging, ... to respond to different pressure rates, leading to hypertension ... various cardiovascular disorders such as heart failure, stroke, coronary ... growing in prevalence each year. WHO estimates that 17 ...
Breaking Medicine Technology:
(Date:5/28/2016)... Aliso Viejo, California (PRWEB) , ... May 28, 2016 , ... ... just need to drag and drop a preset onto their media," said Christina Austin ... from Pixel Film Studios, editors can quickly and easily add stylish color grades to ...
(Date:5/27/2016)... ... 27, 2016 , ... Southland Log Homes , designer and manufacturer of ... kits, which can be found on its website at SouthlandLogHomes.com. , The designs of ... they highlight the craftsmanship of timber post and beam construction. The result is ...
(Date:5/27/2016)... New York, NY (PRWEB) , ... May 27, 2016 , ... ... the factors of a stroke, which we as a society can control and change. ... a stroke occurs nearly every 40 seconds within the United States. Plus, with an ...
(Date:5/27/2016)... (PRWEB) , ... May 27, 2016 , ... Aimed at ... human interest stories, which come courtesy of leaders in the nursing and health care ... from leading advocates and associations—namely Abilene Christian University. , As the nursing industry ...
(Date:5/26/2016)... Hampshire (PRWEB) , ... May 26, 2016 , ... ... care products, has been honored with a 2016 When Work Works Award for its ... award, part of the national When Work Works project administered by the Families and ...
Breaking Medicine News(10 mins):