Article posted today from Bloomberg on 3 patients in Transgene vaccine trial (TG4040) that developed blood disorders normally associated with interferon. TG4040 was given with peg-inf and RBV in their clinical trial - it's not clear whether the blood disorders were due to the vaccine or the interferon component of the therapy.
Transgene Says 3 Patients in Hepatitis Trial Had Blood Disorders
October 11, 2011, 1:57 PM EDT
Oct. 11 (Bloomberg) -- Transgene SA said three patients in a mid-stage trial for its TG4040 vaccine to treat chronic hepatitis C developed blood disorders, prompting the biotechnology company to propose changing the study’s design.
One patient suffered aplastic anemia and two others developed thrombocytopenia, including one with neutropenia, after interferon therapy and not during direct treatment with TG4040, said Transgene, whose biggest shareholder is the French family headed by Alain Merieux, in an e-mailed statement today. TG4040 is used in combination with pegylated interferon alpha and ribavirin in the study, which included 154 people.
“A possible relationship with TG4040 cannot be today formally ruled out and is under active investigation,” the company, based near Strasbourg, France, said in the statement. “The company has decided to submit an amendment to the study design so as to avoid further exposing patients to possible similar adverse events.”
No such side effects occurred in an early-stage trial involving 39 patients who hadn’t received treatment for the disease, Transgene said. These severe events are possible though rare with the standard treatment alone, the company said.
A voicemail message left for Elisabetta Castelli, a Transgene spokeswoman, wasn’t immediately returned after business hours.
Aplastic anemia is a condition in which bone marrow doesn’t produce enough new blood cells. Thrombocytopenia is a decrease in platelets, a component of blood that aids clotting, and neutropenia is a decrease in neutrophils, the most common type of white blood cell.
Hepatitis C is caused by a virus that leads to chronic disease in 75 percent to 85 percent of those infected, according to the U.S. Centers for Disease Control and Prevention in Atlanta. About 170 million people carry the virus worldwide, the CDC said on its website.
--Editor: Kristen Hallam, Chris Staiti
To contact the reporter responsible for this story: Andrea Gerlin in London at agerlin@bloomberg.net
To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net
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