Printer Friendly
The Free Library
19,585,946 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Advanced Cell Technology Enters Into Letter of Intent to Acquire Mytogen, Inc. and Proceed with the Human Clinical Trials Utilizing Myoblasts for the Treatment of Heart Failure.


Company Plans to Commence Phase II Human Clinical Trials to Treat Heart Failure Utilizing Autologous autologous /au·tol·o·gous/ (aw-tol´ah-gus) related to self; belonging to the same organism.

au·tol·o·gous
adj.
1.
 Myoblast myoblast /myo·blast/ (mi´o-blast) an embryonic cell which becomes a muscle cell or fiber.myoblas´tic

my·o·blast
n.
A primitive muscle cell having the potential to develop into a muscle fiber.
 Stem Cell Therapy stem cell therapy Cell therapy Molecular medicine A technology in which a person's own cells–eg, neuronal stem cells are triggered to revert to their primitive embryonic form, then redifferentiate into mature cells of various organs  Following Successful Phase I Human Clinical Trials Already Completed.

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 that it has entered into a letter of intent to acquire Mytogen, Inc. and its Myoblast Program for the treatment of heart failure. The letter of intent provides for an aggregate purchase price of $5 million payable in ACTC common stock plus the assumption of certain Mytogen liabilities of approximately $1 million. Mytogen will also receive a warrant to purchase an additional 1.5 million shares of ACTC common stock at $1.00 subject to achievement of certain milestones. The letter of intent is subject to several closing conditions including requisite approvals from 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.
), final intellectual property due diligence Research; analysis; your homework. This term has caught on in all industries, because it sounds so "wired." Who would want to do analysis or research when they can do due diligence. See wired.  and execution of a definitive agreement. The transaction is scheduled to close by July 15, 2007. Upon completion of the acquisition, Advanced Cell Technology will transition from a development stage to a clinical stage company. Mytogen brings to the Company over ten years of experience in clinical trial and FDA experience in developing and advancing cellular therapies including the area of stem cells stem cells, unspecialized human or animal cells that can produce mature specialized body cells and at the same time replicate themselves. Embryonic stem cells are derived from a blastocyst (the blastula typical of placental mammals; see embryo), which is very young .

In regard to the Myoblast Program, Mytogen has completed successful Phase I Human Clinical Trials utilizing the therapy safely in over forty patients. The FDA has reviewed the "end-of-Phase I" data and allowed Mytogen to proceed with a Phase II Human Clinical Trial. Upon the close of the acquisition, Advanced Cell Technology plans to commence the Phase II Human Clinical Trial for the treatment of heart failure in approximately 160 patients. If successful, the Company expects to proceed with a pivotal Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA  Trial for the therapy.

The Myoblast Program may prove particularly beneficial for patients who have experienced a serious heart attack and have a high risk of heart failure. The stem cell therapy involves transplantation of expanded autologous Myoblasts (adult progenitor pro·gen·i·tor
n.
1. A direct ancestor.

2. An originator of a line of descent.



progenitor

ancestor, including parent.


progenitor cell
stem cells.
 stem cells) derived from a small biopsy of skeletal muscle from a patient's leg. The Mytogen technology allows expansion of Myoblasts into hundreds of millions of cells over a period of two to three weeks. The resulting Myoblasts are then transplanted back into the patient's scarred heart tissue through the use of a catheter-based procedure. While the Phase I Human Clinical Trials were focused on the safety of the therapy, the clinical data from those trials suggests that the Myoblasts persist, often improve function in the heart and can lead to a significant increase in quality of life for the patient.

Advanced Cell Technology is interested in the Myoblast Program because of its potential to treat heart attack and heart failure. This is an area of significant focus for Company because of its Hemangioblast program. The catheter-based procedure of the Myoblast Program is similar to procedures that ACTC anticipates using with its Hemangioblast cell therapy. Advanced Cell Technology believes the combination of the Myoblast Program's target indication of heart failure, the catheter method of administration, and the stage of its human clinical trials, will likely generate significant findings and expertise relevant to the Company's Hemangioblast Program. The Company believes that the "here and now" of the autologuous adult stem cell Adult stem cells are undifferentiated cells found throughout the body that divide to replenish dying cells and regenerate damaged tissues. Also known as somatic (from Greek Σωματικóς, of the body  therapy enables the treatment of patients today and importantly will also help deliver on the "promise of tomorrow" of human embryonic stem cell Embryonic stem cells (ES cells) are stem cells derived from the inner cell mass of an early stage embryo known as a blastocyst. Human embryos reach the blastocyst stage 4-5 days post fertilization, at which time they consist of 50-150 cells.

ES cells are pluripotent.
 therapies.

Dr. Pedro Huertas, Chief Development Officer of Advanced Cell Technology remarked, "Mytogen has a very experienced team and is the only company that has successfully brought its technology into clinical trials in accordance with FDA regulations. The Myoblast Program takes us directly into Phase II clinical trials and is thoroughly aligned with various applications of our Hemangioblast Program."

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 Advanced Cell Technology remarked, "We remain fully committed (Law) committed to prison for trial, in distinction from being detained for examination.

See also: Fully
 to the field of human embryonic stem cells and we believe that the promise of the Myoblast Program combined with the synergies with our Hemangioblast program provides a diverse technology platform in stem cell therapy focused on the treatment of heart attack and heart failure. We are excited to welcome Dr. Jonathan Dinsmore and the entire Mytogen team who have been together for over ten years to Advanced Cell Technology and look forward to the continued success of the Myoblast Program. We look forward to closing the transaction with Mytogen as quickly as practicable and integrating their technology and scientific team within our organization."

Additional details regarding the letter of intent with Mytogen will be included in a Current Report on Form 8-K Form 8-K

The form required by the SEC when a publicly held company incurs any event that might affect its financial situation or the share value of its stock.


Form 8-K

See 8-K.
 to be filed by the Company with the Securities and Exchange Commission.

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 Alameda is a city in Alameda County, California, United States. It is located on a small island of the same name next to Oakland, California in the San Francisco Bay. An additional part of the city is Bay Farm Island, which is adjacent to the Oakland International Airport.  and Worcester, Massachusetts.

More information is available at www.advancedcell.com

About Mytogen, Inc.

Mytogen, Inc. is a Massachusetts based company developing autologous myoblast transplantation designed to restore cardiac function in patients with heart failure. The incidence and progressive nature of heart disease make it the leading cause of morbidity and mortality Morbidity and Mortality can refer to:
  • Morbidity & Mortality, a term used in medicine
  • Morbidity and Mortality Weekly Report, a medical publication
See also
  • Morbidity, a medical term
  • Mortality, a medical term
 in the U. S. Mytogen is advancing a proprietary formulation of cultured human myoblasts and an optimized delivery system to deliver cells to the site of cardiac damage. Mytogen represents the consolidation of experts in areas including clinical manufacturing of biologics, cell transplantation, and stem cell stem cell

In living organisms, an undifferentiated cell that can produce other cells that eventually make up specialized tissues and organs. There are two major types of stem cells, embryonic and adult.
 biology and benefits from intellectual property assets and clinical trial experience acquired from Genvec and Diacrin, Inc. Currently, Mytogen is conducting U.S. human clinical trials of its myoblast therapy with FDA oversight, and is positioned to launch multi-center phase II studies in the near future.

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.
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.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Date:May 31, 2007
Words:1171
Previous Article:On Center Software CEO Named to Constructech Technology Advisory Board.
Next Article:Glowpoint CEO to Speak at Telepresence World.
Topics:



Related Articles
Medtronic, Genzyme Form Joint Venture to Target Cardiac Repair; MG Biotherapeutics to Develop Treatments that Combine Cell Therapy, Medical Devices.
Cytokinetics to Present at the Friedman Billings Ramsey 9th Annual Growth Investor Conference.
Cytokinetics to Present at the Pacific Growth Equities 2005 Life Sciences Growth Conference.
Cytokinetics to Present at the Goldman Sachs Twenty-Sixth Annual Global Healthcare Conference.
PHARMASSET TO DEVELOP CLEVUDINE FOR HEPATITIS B.
Cytokinetics to Present at the 12th Annual NewsMakers in the Biotech Industry Conference.
Cytokinetics to Present at the Bear Stearns 18th Annual Healthcare Conference.
Cytokinetics Provides Clinical Trials Update for Ispinesib (SB-715992).
GenVec Completes Previously Announced Sale of Myoblast Cell Therapy Program.
Advanced Cell Technology to Host Conference Call and Webcast to Discuss Recent Developments and Planned Acquisition of Mytogen.

Terms of use | Copyright © 2012 Farlex, Inc. | Feedback | For webmasters | Submit articles