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Advanced Cell Technology Announces Critical Advancements in Its RPE Program for the Treatment of Macular Degeneration and Other Retinal Degenerative Diseases.


Company Commences GLP See gateway location protocol.  Safety Studies with MPI MPI - Message Passing Interface  Research for RPE Cells Manufactured under GMP GMP (guanosine monophosphate): see guanine.  Compliant Conditions

ALAMEDA, Calif. -- Advanced Cell Technology, Inc. (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
:ACTC ACTC Apple Certified Technical Coordinator
ACTC Almaden Cycle Touring Club
ACTC Associated Colleges of the Twin Cities
ACTC All Ceylon Tamil Congress (Sri Lanka)
ACTC Association Canadienne de Télévision par Câble
) today announced major advancements in the process of bringing its Retinal Pigment Epithelial (RPE) program into the clinic to treat various retinal degenerative diseases, including Age-Related Macular Degeneration Age-related macular degeneration (ARMD)
Degeneration of the macula (the central part of the retina where the rods and cones are most dense) that leads to loss of central vision in people over 60.
 (AMD (Advanced Micro Devices, Inc., Sunnyvale, CA, www.amd.com) A major manufacturer of semiconductor devices including x86-compatible CPUs, embedded processors, flash memories, programmable logic devices and networking chips. ). After preliminary discussions earlier this year with staff from the Office of Cellular, Tissue, and Gene Therapies within the Center for Biologics Evaluation and Research The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the Food and Drug Administration, which is in the United States Department of Health and Human Services.  at the Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
), the company has contracted with a leading contract research organization in order to commence work on an extensive preclinical program. Earlier this month, MPI Research, located in Mattawan, Michigan, initiated pilot studies under Good Laboratory Practices (GLP) for Advanced Cell Technology's (ACT) ongoing RPE program.

This study is the first of several that will provide substantial safety data for an Investigational New Drug (IND) application, necessary for the initiation of a clinical trial. Due to the complex nature of stem cell derived cellular therapies, these studies are original, unique, and state-of-the-art. The protocols utilize therapeutic dosage levels of RPE cells based on recent data obtained through pharmacological dosage studies in the RCS (1) (Remote Computer Service) A remote timesharing service.

(2) (Revision Control System) A Unix utility that provides version control.

RCS - Revision Control System
 rat, a key animal model of retinal disease. For the preliminary GLP studies, the company is utilizing RPE cells that have been differentiated from human embryonic stem cells, under current Good Manufacturing Practice Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice') is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products.  (cGMP) conditions in its Worcester, Massachusetts facility. Applying appropriate controls as specified in the FDA's cGMP regulations, ACT staff was able to produce master and working cell banks of human embryonic stem cells. In working out a controlled, compliant manufacturing methodology, an unlimited amount of RPE cells can be derived by ACT for clinical use.

ACT scientists have also developed novel methodology to cryopreserve cry·o·pre·serve  
tr.v. cry·o·pre·served, cry·o·pre·serv·ing, cry·o·pre·serves
To preserve (cells or tissue, for example) by freezing at very low temperatures.
 the RPE cell product, thereby overcoming various clinical issues faced by other cell therapy companies. ACT is planning for further dialogue with the FDA, as well as additional safety testing and other innovative analyses of the RPE cell product. ACT believes the commencement of these studies with all the work that lead up to them represents a significant milestone towards the program's success and future clinical trial.

Pedro Huertas, M.D., Ph.D., Chief Development Officer of Advanced Cell Technology remarked, "This is an important step for us and a tribute to the efforts of our team in translating a scientific finding into a potential therapeutic application. We expect that the GLP studies will move us closer to the successful filing of an IND and to FDA regulated clinical trials of RPE cells to treat retinal degenerative diseases."

Mr. William M. Caldwell, IV, Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of ACTC commented, "I am very proud to announce the extensive work to date on the RPE program for our company. We remain steadfast in our commitment to drive our therapeutic programs to the clinical stage."

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc. is a biotechnology company applying embryonic stem cell technology in the emerging field of regenerative medicine. The company operates facilities in Alameda, California and Worcester, Massachusetts.

About MPI Research

MPI Research, with headquarters in Mattawan, Michigan, is one of the worlds leading providers of comprehensive preclinical research and development services. More information on the company's services can be obtained through the website at www.mpiresearch.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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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-QSB for the quarter ended March 31, 2007. 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.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Jun 20, 2007
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