AP/Human Genome Down on Drug Side Effects Wednesday January 23, 8:55 am ET Human Genome Shares Plunge Premarket on Side Effects Seen in Hepatitis C Drug Trial
ROCKVILLE, Md. (AP) Shares of Human Genome Sciences Inc. plummeted in Wednesday premarket trading after the biopharmaceutical company said it will lower the dosage of its experimental hepatitis C drug Albuferon in response to serious lung-related safety concerns.
Shares of Human Genome dropped $2.22, or 22.2 percent, to $7.80 in premarket activity, having closed Tuesday at $10.02.
Following a routine review, an independent data monitoring committee cited serious lung-related side effects in patients receiving 1200-microgram injections every two weeks of Albuferon. Patients in the Phase 3 trials who were receiving that dosage will now receive a lower 900-mcg injection every two weeks. No safety concerns were cited with the lower dose.
Human Genome said it continues to expect Phase 3 data to be available by spring 2009 to support the filing of global marketing approval applications by fall 2009. The company is currently conducting two late-stage clinical trials of Albuferon in combination with antiviral medication ribavirin.
Albuferon is being developed by Human Genome and Novartis under a worldwide co-development and marketing agreement signed in June 2006. Albuferon is a new, longer-acting form of interferon alpha, a biological therapy used to treat various cancers. Interferon acts to weaken tumor cells and make them more susceptible to attack by the body's immune system.
Hepatitis C is a virus which infects the liver, causing severe liver damage or liver cancer.
HGSI HUMAN GENOME SCIENCES, INC. Fidelity Investments Last [Tick] 6.575[ + ] Change -3.445 % Change -34.38% ...............OUCH! Bid 6.56 Bid Size 4 Ask 6.58 Ask Size 11 Open 7.20 Volume 7,349,402 Day High 7.20 Day Low 6.55 Previous Close 10.02