HepaLife to Accelerate Research Activities and Bolster Management and Research Teams.VANCOUVER, British Columbia -- Encouraging Research Outcomes, Evolving Corporate Events, and Continued Rise in Acetaminophen-Related Acute Liver Failure Acute liver failure is the appearance of severe complications rapidly after the first signs of liver disease (such as jaundice), and indicates that the liver has sustained severe damage (loss of function of 80-90% of liver cells). , Spur HepaLife's Accelerated Expansion Plans HepaLife Technologies, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :HPLF) (FWB (Fixed Wireless Broadband) See fixed wireless. :HL1) today unveiled plans to accelerate its research and development activities for the first-of-its-kind 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 based on the patented PICM-19 cell line, which thus far has demonstrated to be highly metabolic and ideally suited for incorporation into an artificial liver device. Recently, positive research findings related to the prolonged survival, density and function of HepaLife's cell line were presented at the annual 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. These cells are considered the most crucial component of the Company's 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, all currently under development through a collaborative research effort. Prompted by favorable research outcomes, evolving corporate events, and continued demand for liver disease treatment (as recently highlighted in the current issue of Hepatology, the official journal of the American Association for the Study of Liver Diseases (HEPATOLOGY 2006;43:618-631)), HepaLife also announced its immediate intention to further expand its scientific and management teams. "Having surpassed a number of critical research and corporate finance milestones, we strongly believe that it is now time for HepaLife to take full advantage of its intellectual and financial resources, and aggressively pursue our primary research through the addition of key management and scientific research staff," 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. "While our research findings are an important cell engineering achievement," explained Mr. Rayat. "I'm equally pleased with corporate and finance developments at the Company. Most importantly, on February 16, 2005, we commenced funding under our $15,000,000 common stock purchase agreement with Fusion Capital Fund, II. This event marks an important milestone for us, and permits us to move forward with our core research activities of creating the first-of-its-kind artificial liver device and developing proprietary in vitro toxicology and pre-clinical drug testing platforms." Drug toxicity to the liver commonly causes Drug-Induced Liver Injury (DILI Dili (dē`lē), city (2002 est. pop. 49,900), capital of East Timor. on the N coast of Timor, on Ombai Strait. Dili is the largest city and chief port and commercial center of East Timor. ), a primary contributor to Acute Liver Failure (ALF ALF - Algebraic Logic Functional language ) in both adults and children. Drug-induced liver damage, also known as hepatotoxicity hepatotoxicity (hepˑ· The most commonly cited pharmaceutical agent responsible for Drug-Induced Liver Damage is acetaminophen acetaminophen (əsēt'əmĭn`əfĭn), an analgesic and fever-reducing medicine similar in effect to aspirin. It is an active ingredient in many over-the-counter medicines, including Tylenol and Midol. . Acetaminophen-related liver toxicity is the leading cause of hepatic failure requiring liver transplantation in Great Britain and the second most common cause of liver failure requiring transplantation in the United States. In the March 2006 issue of Hepatology, researchers emphasized how prevalent Drug-Induced Liver Injury (DILI) has become in ALF patients: "More than half of all instances of ALF identified in the multi-center Acute Liver Failure Study Group (ALFSG ALFSG Animal Liberation Front Supporters Group ) registry from 25 U.S. sites are due to DILI; 3/4 of the DILI cases are accounted for by acetaminophen. Disturbingly, the proportion of acetaminophen cases among all ALF cases has increased steadily since 1998, with acetaminophen accounting for 51% of all cases over the last 2 years." The same report further confirms that "...acetaminophen is even more commonly a cause for ALF than had previously been recognized." Acetaminophen is one of the most common pharmaceuticals associated with both intentional and accidental poisoning, and is found in more than 100 products. Acetaminophen is also the most widely used pharmaceutical analgesic analgesic (ăn'əljē`zĭk), any of a diverse group of drugs used to relieve pain. Analgesic drugs include the nonsteroidal anti-inflammatory drugs (NSAIDs) such as the salicylates, narcotic drugs such as morphine, and synthetic drugs and antipyretic antipyretic /an·ti·py·ret·ic/ (-pi-ret´ik) 1. relieving or reducing fever. 2. an agent that so acts. an·ti·py·ret·ic n. An agent that reduces or prevents fever. agent, worldwide. Sadly, Drug-Induced Liver Injury also accounts for 25% of childhood Acute Liver Failure. According to the report: "Drugs which are prominent among those causing childhood DILI include acetaminophen; the group of anti-epileptics including phenytoin phenytoin /phen·y·to·in/ (fen´i-toin?) an anticonvulsant used in the control of various kinds of epilepsy and of seizures associated with neurosurgery. phen·y·to·in n. , carbamazepine carbamazepine /car·ba·maz·e·pine/ (kahr?bah-maz´e-pen) an anticonvulsant and analgesic used in the treatment of pain associated with trigeminal neuralgia and in epilepsy manifested by certain types of seizures. , andphenobarbital; valproic acid; sulfonamides Sulfonamides Definition Sulfonamides are medicines that prevent the growth of bacteria in the body. Purpose Sulfonamides are used to treat many kinds of infections caused by bacteria and certain other microorganisms. ; pemoline pemoline /pem·o·line/ (pem´ah-len) a central nervous system stimulant used in the treatment of attention-deficit. pem·o·line n. (recently withdrawn from the market); minocycline; and most-anti-neoplastic drugs. Where drug therapy plays a key role -- epilepsy and childhood neoplasia neoplasia /neo·pla·sia/ (-pla´zhah) the formation of a neoplasm. cervical intraepithelial neoplasia -- drug hepatotoxicity is rather frequent. Children can also develop DILI from herbals and from recreational drugs." ABOUT HEPALIFE TECHNOLOGIES, INC. HepaLife Technologies, Inc. (OTCBB:HPLF) (FWB:HL1) 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 “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. , 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. 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 In 2003 alone, the inability to accurately predict toxicity early in drug development cost the pharmaceutical industry a record $8 billion. In particular, hepatotoxicity, 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 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 potential drugs fail pre-clinical or clinical trials due to the toxic nature of the compounds being tested, accounting for an estimated $70 million (20%) of total research and development costs per drug. 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 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 HTML in full HyperText Markup Language Markup language derived from SGML that is used to prepare hypertext documents. Relatively easy for nonprogrammers to master, HTML is the language used for documents on the World Wide Web. text of this release, please visit http://www.hepalife.com/Investor/PressReleases/20060309-1.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 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, 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 ongoing 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-QB and Form 10-KB filings with the Securities and Exchange Commission. These reports and filings may be inspected and copied at the Public Reference Room maintained by the U.S. Securities & Exchange Commission at 100 F Street, N.E., Washington, D.C. 20549. You can obtain information about operation of the Public Reference Room by calling the U.S. Securities & Exchange Commission at 1-800-SEC-0330. The U.S. Securities & Exchange Commission also maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the U.S. Securities & Exchange Commission at http://www.sec.gov. 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. |
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