Printer Friendly
The Free Library
6,672,335 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Positive Results from Latest Experiments Released by HepaLife's Collaborating USDA Research Team.


VANCOUVER, British Columbia -- USDA USDA,
n.pr See United States Department of Agriculture.
 Bioengineer, Dr. Ayesha Mahmood, Presents Brand New 'Survival and Function' Data in Support of HepaLife's PICM-19H Liver Cells at National Biomedical Engineering Biomedical engineering

An interdisciplinary field in which the principles, laws, and techniques of engineering, physics, chemistry, and other physical sciences are applied to facilitate progress in medicine, biology, and other life sciences.
 Society Meeting

HepaLife Technologies, Inc. (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
:HPLF) (FWB (Fixed Wireless Broadband) See fixed wireless. :HL1), a development-stage biotechnology company focused on the identification, development and eventual commercialization of technologies and products for liver toxicity detection and the treatment of various forms of liver dysfunction and disease, today announces that positive data from recent experiments on the Company's PICM-19H liver cell line was released at last week's national Biomedical Engineering Society Meeting (BMES BMES Biomedical Engineering Society ) in Baltimore, Maryland.

HepaLife's collaborating USDA scientist, Dr. Ayesha Mahmood, presented favorable research findings from important experiments related to the culture maintenance, culture density, and hepatocyte hepatocyte /hep·a·to·cyte/ (hep´ah-to-sit?) a hepatic cell.

hep·a·to·cyte
n.
A parenchymal liver cell.


Hepatocyte
A liver cell.
 function of the PICM-19H cell line. These cells are the most crucial component of the Company's artificial liver artificial liver Biotech A cartridge with cloned human liver cells, through which blood flows to facilitate removal of waste products. See Extracorporeal liver assist device, Liver dialysis.  device, and are currently undergoing evaluation and testing through a cooperative research and development agreement “CRADA” redirects here. For other uses, see CRADA (disambiguation).

A Cooperative Research and Development Agreement (CRADA) is an agreement between a government agency and a private company to work together.
 (CRADA CRADA Cooperative Research And Development Agreement ) with the USDA.

Recent research has worked towards the optimization of culture conditions for the Company's proprietary PICM-19H liver cell line in order to enable faster cell growth, higher final cell densities, and to achieve optimal function of key liver metabolic and detoxification Detoxification Definition

Detoxification is one of the more widely used treatments and concepts in alternative medicine. It is based on the principle that illnesses can be caused by the accumulation of toxic substances (toxins) in the body.
 enzyme systems. As explained in HepaLife's September 19, 2005, press release, successful research outcomes will result in the incorporation of PICM-19H cells in an artificial liver device for use by patients suffering from chronic and acute liver disease Liver Disease Definition

Liver disease is a general term for any damage that reduces the functioning of the liver.
Description

The liver is a large, solid organ located in the upper right-hand side of the abdomen.
, as well as use in in vitro toxicology In vitro toxicology is the scientific analysis of the effects of toxic chemical substances on cultured bacteria or mammalian cells. In vitro (literally 'in glass') testing methods are employed primarily to identify potentially hazardous chemicals and/or to confirm  and pre-clinical drug testing platforms.

A full copy of the Company's September 19, 2005, press release can be viewed here:

http://www.hepalife.com/Investor/PressReleases/20050919-1.html

Research Shows Prolonged Survival & Function of HepaLife's PICM-19H Liver Cells

While presenting her findings at America's biggest annual bioengineering meeting, Dr. Mahmood presented new data showing that PICM-19H cells were able to survive at room temperature for days and then recover their full hepatic function hepatic function (h·paˑ·tik funkˑ·sh  within 24 hours of being brought back to normal body temperature (37 degrees C). Thus, Dr. Mahmood's research outcomes demonstrate that PICM-19H cell function is not compromised due to prolonged room temperature exposure or storage.

When exposed to room temperature for up to six days, the PICM-19H cells maintained enough metabolic activity to be able to remain fully functional in place in a bioreactor bioreactor

a container in which living organisms carry out a biological reaction.
. At the end of various room temperature storage periods, the cell cultures recovered their normal body temperature metabolic activity. Metabolic rates were measured by way of the WST-1 uptake method, which indicates cell energy production from mitochondrial mitochondrial

pertaining to mitochondria.


mitochondrial RNAs
a unique set of tRNAs, mRNAs, rRNAs, transcribed from mitochondrial DNA by a mitochondrial-specific RNA polymerase, that account for about 4% of the total cell RNA that
 activity.

Furthermore, PICM-19H cells exposed to room temperature for up to six days were able to successfully maintain the most vital liver functions of P450 activity, ammonia clearance, and urea production. In all cases, these liver cell functions of the PICM-19H cells remained equivalent to control PICM-19 cells that were maintained at body temperature at all times -- an important finding which demonstrates that PICM-19H cells were able to perform liver functions even after exposure to room temperature for several days.

In addition, the initial high cell densities of the PICM-19H cell cultures were maintained throughout the six day room temperature period. Cell density is vital, since a higher cell density enables the most efficient function of a bioreactor, and it is the bioreactor which will comprise the key component of HepaLife's artificial liver device. The maintenance of the high cell density demonstrated that little or no cell death occurred despite the exposure to the abnormally low (hypothermic hy·po·ther·mi·a  
n.
Abnormally low body temperature.



[hypo- + Greek therm
) temperature conditions.

In conclusion, the results show that PICM-19H cell function was not compromised due to prolonged RT exposure and storage.

"These findings positively support our long-held belief that our cells are able to survive, function, and multiply in environments where most other liver cells simply cannot," explained Mr. Harmel S. Rayat, President 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 HepaLife.

"Through this research, we now know that PICM-19H cells can be transported at ambient or room temperature without loss of function. This means that we're not burdened by frozen cell storage protocols or body temperature incubation requirements in the commercial application of these cells to an artificial liver device or in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment.

in vi·tro
adj.
In an artificial environment outside a living organism.
 toxicology/pharmacology assay platforms.

"Most importantly, researchers anticipate that once the artificial liver device is in place for medical use, maintenance of the device will not require special conditions. For example, our cells can sit in a clinical setting without 're-feeding' or related maintenance; a significant benefit to end users, who will be able to use the device without sophisticated cell biology support.

"These research findings mark an important cell engineering achievement for HepaLife," concluded Mr. Rayat. "I'm especially pleased that for the first time ever, we were able to present PICM-19H data to our peers in the scientific community through the BMES meeting."

The Biomedical Engineering Society is America's lead society for the accreditation of biomedical bi·o·med·i·cal
adj.
1. Of or relating to biomedicine.

2. Of, relating to, or involving biological, medical, and physical sciences.
 and bioengineering programs.

ABOUT HEPALIFE TECHNOLOGIES, INC.

HepaLife Technologies, Inc. (OTCBB:HPLF) is a development-stage biotechnology company focused on the identification, development and eventual commercialization of technologies and products for liver toxicity detection and the treatment of various forms of liver dysfunction and disease.

Currently, HepaLife is concentrating its efforts on creating the first-of-its-kind artificial liver device and developing proprietary in vitro toxicology and pre-clinical drug testing platforms.

Artificial Liver Device

Presently, through a Cooperative Research and Development Agreement, HepaLife Technologies is working towards optimizing the hepatic functionality of the patented PICM-19 cell line. The hepatic characteristics of the PICM-19 cell line have been demonstrated to have potential application in the production of an artificial liver device for use by human patients with liver failure liver failure Clinical medicine Liver insufficiency that results in death, requires a liver transplant, or is characterized by recovery after encephalopathy, or while awaiting a transplant; also defined as a condition with ≥ 3 of following: albumin < 3. .

With 25 million Americans suffering from liver disease, the need for an artificial liver device able to remove toxins and improve immediate and long-term survival results is more critical today than ever before. Limited treatment options, a low number of donor organs, the high price of transplants and follow-up costs, a growing base of hepatitis, alcohol abuse, drug overdoses, and other factors that result in liver disease all clearly indicate a strong need for an artificial liver device.

In Vitro Toxicology Testing

Hepatotoxicity hepatotoxicity (hepˑ··tō·t , or liver damage caused by medications and other chemical compounds, is the single most common reason leading to drug withdrawal or refusal of drug approval by 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.
). In fact, about one third of all drugs fail pre-clinical or clinical trials due to the toxic nature of the compounds being tested, costing pharmaceutical companies around $2 billion annually on such toxicity-related drug failures.

With the cost to develop an FDA-approved drug approaching $1 billion and taking 10 to 15 years, a 10% improvement in predicting failures before clinical trials could save $100 million in development costs per drug. Despite efforts to develop better methods, most of the tools used for toxicology and human safety testing are decades old.

The PICM-19 cells grown in vitro synthesize liver specific proteins such as albumin and transferrin transferrin /trans·fer·rin/ (-fer´in) a glycoprotein mainly produced in the liver, binding and transporting iron, closely related to the apoferritin of the intestinal mucosa.

trans·fer·rin
n.
, and display enhanced liver-specific functions such as ureagenesis and cytochrome cytochrome (sī`təkrōm'), protein containing heme (see coenzyme) that participates in the phase of biochemical respiration called oxidative phosphorylation.  P450 activity. As a result, HepaLife, using the patented PICM-19 cell line, plans to develop proprietary in vitro toxicological and pre-clinical drug testing platforms that will more accurately determine the potential toxicity and metabolism of new pharmacological compounds in the liver.

At present, the Company does not have commercial products intended to diagnose, treat, cure or prevent any disease. The statements contained in this press release regarding our ongoing research and development and the results attained by us to date have not been evaluated by the Food and Drug Administration.

For additional information, please visit www.hepalife.com

To receive future press releases via email, please visit:

http://www.hepalife.com/Alerts-Index.asp

To view the full HTML text of this release, please visit:

http://www.hepalife.com/Investor/PressReleases/20051004 -1.html

Legal Notice Regarding Forward-Looking Statements

No statement herein should be considered an offer or a solicitation of an offer for the purchase or sale of any securities. This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although the Company believes that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, it can give no assurance that such expectations and assumptions will prove to have been correct. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties, including, but not limited to, adverse economic conditions, intense competition, lack of meaningful research results, entry of new competitors and products, adverse federal, state and local government regulation, inadequate capital, unexpected costs and operating deficits, increases in general and administrative costs administrative costs,
n.pl the overhead expenses incurred in the operation of a dental benefits program, excluding costs of dental services provided.
, termination of contracts or agreements, technological obsolescence ob·so·les·cent  
adj.
1. Being in the process of passing out of use or usefulness; becoming obsolete.

2. Biology Gradually disappearing; imperfectly or only slightly developed.
 of the Company's products, technical problems with the Company's research and products, price increases for supplies and components, litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
 and administrative proceedings involving the Company, the possible acquisition of new businesses or technologies that result in operating losses or that do not perform as anticipated, unanticipated losses, the possible fluctuation and volatility of the Company's operating results, financial condition and stock price, losses incurred in litigating and settling cases, dilution in the Company's ownership of its business, adverse publicity and news coverage, inability to carry out research, development and commercialization plans, loss or retirement of key executives and research scientists, changes in interest rates, inflationary factors, and other specific risks. We currently have no commercial products intended to diagnose, treat, prevent or cure any disease. The statements contained in this press release regarding our on going research and development and the results attained by us to date have not been evaluated by the Food and Drug Administration. There can be no assurance that further research and development, and/or whether clinical trial results, if any, will validate and support the results of our preliminary research and studies. Further, there can be no assurance that the necessary regulatory approvals will be obtained or that HepaLife will be able to develop commercially viable products on the basis of its technologies. In addition, other factors that could cause actual results to differ materially are discussed in the Company's most recent Form 10-QSB and Form 10-KSB filings with the Securities and Exchange Commission. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, 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:Oct 5, 2005
Words:1755
Previous Article:XOMA Expands BCE Technology License With Crucell.
Next Article:ShoreTel Names Industry Veteran Joe Vitalone Vice President of Sales and Business Development.



Related Articles
Pig vaccine back on sale; query begins.
Processing of rice bran may affect its cancer-fighting potential.
Extrusion may make rice more healthful.
Branding change: USDA Rural Development battles lack of awareness with new branding initiative.(THINKING OUTSIDE THE BOX)
Develop novel foods from agriculture.
HEPALIFE COLLABORATES WITH USDA ON LIVER STORAGE RESULTS.
Brightly colored wraps.(Executives: FYI ...)
Washing, sanitizing techniques to make produce safer.

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles