Las Vegas-based CardioVascular BioTherapeutics, Inc.was approved by the FDA to enter into Phase II of its clinical trials for its heart drug. The approval by the FDA for Phase II is a major accomplishment for CVBT. In the first Phase I trial, the company demonstrated, as required for a Phase I study, that there were no side effects of the drug. Although the Phase I trials are solely focused on toxicity of the drug, the patients in Phase I saw a marked improvement in their severe heart disease. CVBT’s heart drug FGF-141 was injected into the hearts of no-option heart patients to grow new blood vessels. Eligible patients must have had at least a double by-pass operation and not have any other options available for treatment. The patients in Phase I reported feeling better and showed marked improvements in their SPECT tests. Many of the patients said that they could resume their normal activities, such as walking, going up stairs, shopping and even, returning to work. At a reunion of patients from the US Phase I trials in Cincinnati in 2006, patients and family members thanked the team from CVBT. Some of the patients’ stories:
Constance Donley, age 51, of Cold Spring, Kentucky was the first patient in the
United States to receive the FGF1 injection in November 2003. Donley began
suffering severe angina following the first of three open-heart procedures in
1998. A medical records clerk at Deaconess Hospital, Donley found it hard to
work a full day, crippled by her constant chest pain. Now, twelve weeks later the
results are promising. "I feel great," said Donley. The mother of five smiled as
she reported, "I am back at work full time and doing more and more everyday."
Claudia Robertson, age 54, of Kettering, Ohio, near Dayton was the second
patient to undergo treatment. Robertson developed severe angina a few months
after her 1999 emergency quadruple bypass. The mother of three, grandmother
of three, is now back to playing trivia on Wednesday nights and shopping
around town.
James Duke, age 57, of Forest Park, Ohio was the third patient to receive
treatment. Duke developed severe angina also after a quadruple bypass in
June 2002. The father of three, he is delighted to have received the option of
angiogenesis treatment. "I am glad it was available to me," said Duke. He is
now happy to be back at work for the Winton Woods School District. [1]
CVBT will now enter Phase II with its heart drug. In this phase they plan on treating 100 patients at sites in the United States and Europe. In Phase II the company will use a catheter to deliver the drug to the heart instead of cutting the chest open to deliver the drug. A small incision in the leg will be made and a catheter will be inserted through the arteries to the heart. The new procedure required two approvals from the FDA, one for the drug and another for the device. CVBT hired a clinical research organization, Kendle International, to help with its application and the Phase II trials. Kendle is among the world's leading global clinical research organizations and is the fourth-largest provider of Phase II-IV clinical development services.
Disclosure: John Laub wrote this article and owns shares of CVBT.
1. “Growth Factor Protein Succeeds in Growing New Coronary Arteries.” News-Medical.Net March 26, 2004.
