Vital Therapies, Inc. Adds Two New Board Members
Vital Therapies, Inc. Adds Two New Board Members
CEO of HeartWare International, Inc. and Former CFO of Amgen Elected to Board of Directors
SAN DIEGO, CA -- (Marketwired) -- 05/16/13 -- Vital Therapies, Inc., a development stage biotechnology company focused on developing the first bio-artificial liver for life-threatening acute liver failure, today announced the election of Doug Godshall and Lowell Sears to the company's Board of Directors.
Doug Godshall is the Chief Executive Officer and a director of HeartWare International, Inc. (NASDAQ: HTWR) (ASX: HIN), a leading innovator in the development and commercialization of miniaturized circulatory support devices for the treatment of advanced heart failure. Under Mr. Godshall's leadership, the HeartWare(R) Ventricular Assist System, otherwise known as the HVAD(R) Pump, received FDA approval in the United States, CE marking in the EU and TGA approval in Australia. The device is now commercialized internationally in 30 countries and generated record revenues of $49.2 million in the first quarter of fiscal year 2013. A U.S. pivotal trial designed to allow potential expansion of the HVAD's label is ongoing and a second generation system, the MVAD(R) is preparing for initial human use in coming months.
Mr. Godshall joined HeartWare in 2006 from Boston Scientific Corporation. During his 16 years at Boston Scientific, Mr. Godshall held various executive and leadership positions, serving as President of the Vascular Surgery Division, member of Boston Scientific's Operating Committee, and Vice President, Business Development.
Lowell Sears joined Amgen in 1986 as Treasurer and Director of Planning and then served as Senior Vice President and Chief Financial Officer from 1988 to 1994, and as Senior Vice President, Asia Pacific from 1992 to 1994. As CFO, he was instrumental in managing Amgen's transformation into a fully integrated global pharmaceutical company. In 1994 he formed Sears Capital Management, Inc. (SCM), a life science venture investment firm where Mr. Sears has helped found and provided seed and early stage capital to 40 pharmaceutical and medical device companies. He has served on the boards of directors of 22 companies both public and private, and currently serves as Chairman of the Board of Cellerant Therapeutics, Inc. (private) and SymBio Pharmaceuticals, KK (JASDAQ: 4582).
About Vital Therapies, Inc.
Vital Therapies, Inc. is a private development-stage biotechnology company based in San Diego, California. The company is developing ELAD, an investigational extracorporeal liver support system which has been studied in seven clinical trials in US, EU and Asia. Moreover, a US/EU phase 3 trial plan designed to support potential BLA and MAA marketing approval has received written guidance from FDA and EMA. The first protocol under this plan, for a survival trial in acute alcoholic hepatitis and alcohol-induced liver decompensation, has been allowed by FDA and has begun enrolling patients. Protocols for the second and third trials, in subjects with acute alcoholic hepatitis who fail steroid therapy and subjects with fulminant hepatic failure, are complete, and clinical sites are being recruited with enrollment expected later this year. Overall, more than 40 clinical sites in USA, EU and Australia are expected to participate. The trials are expected to be complete by the end of 2015.
If results are successful and the marketing application is granted priority review and approved in the USA and EU, market launch could occur on both continents before the end of 2016. Vital Therapies retains all rights to ELAD and has no corporate partners.
ELAD represents the first developmental stage, human allogeneic cellular therapy for life-threatening acute liver failure. The system comprises a bedside system whose central component is four cartridges containing 440 grams of immortalized human hepatoblastoma cells and 32,000 hollow fibers. The patient's plasma flows inside of the hollow fibers to allow two-way transfer of metabolites. The system has been shown to process toxins, and synthesize proteins and metabolites in ways that mimic components of normal human liver function. The ELAD cell cartridges are produced at VTI's GMP-compliant facility in San Diego, California.
About Alcohol-Induced Liver Decompensation (AILD)
AILD is a life-threatening form of liver failure precipitated by the recent ingestion of alcohol which can occur with or without chronic underlying liver disease. One common form is Acute Alcoholic Hepatitis (AAH), which represents a severe inflammatory response to toxic liver injury. AAH is associated with a 75% mortality rate in patients with severe disease who are unresponsive to standard therapy. Another form of AILD occurs in patients with chronic, yet stable underlying liver disease who experience an acute decompensation after alcohol ingestion. Therapy for AILD centers on the use of anti-inflammatory drugs such as corticosteroids and the treatment of secondary complications such as bleeding, kidney failure and hepatic coma. Since abstinence from alcohol for 6 months is considered a pre-requisite for inclusion on a liver transplant list, organ transplantation is generally not available for these patients. Each year, we estimate there are over 30,000 cases of AILD in the United States.
ELAD is a trademark of Vital Therapies, Inc.
This press release may contain forward-looking statements, including but not limited to statements regarding anticipated future closings of the staged financing, the success of our planned phase 3 trials and ELAD's market launch. These statements relate to future events and are subject to risks, uncertainties and assumptions about Vital Therapies, Inc. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. Actual events or results may differ materially. Many factors may cause our actual results to differ materially from any forward-looking statement. We do not undertake to update any forward-looking statements.
CONTACT: Terry Winters Co-Chairman & CEO or Duane Nash CBO Vital Therapies, Inc. 858-673-6840