PHARMACY

Study: Liver disease may be reversed by blood pressure drug

BY Allison Cerra

NEW YORK A blood-pressure medicine has been shown to reverse the effects of early-stage liver failure in some patients.

Newcastle University researchers analysed a small clinical trial of losartan, a drug normally prescribed for hypertension, on 14 patients in Spain, who had Hepatitis C. The illness was at an advanced stage causing fibrosis — scarring in the liver — which would usually have progressed to liver failure.

Half of the patients in the trial saw the scars in their liver shrink allowing the organ to repair itself.

Professor Derek Mann from Newcastle University said: “At the moment we have no proven effective way of treating people with chronic liver disease other than transplantation. This early stage trial has shown that we can shrink liver scarring in some patients and shows promise for a treatment that could make a huge difference to the lives of thousands of people.”

The team, whose work is published in Gastroenterology, said this early stage trial is promising and they now want to carry out several much larger studies initially involving patients with liver disease caused by obesity and then later alcohol, hereditary and autoimmune diseases.

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Pfizer presents investigational cancer drug results at conference

BY Alaric DeArment

ORLANDO Data from a phase 2 study of an investigational lung cancer drug identify patients who may benefit from treatment with the drug, according to abstracts presented at a cancer conference.

Drug maker Pfizer presented three abstracts of a study on figitumumab (CP-751,871) at the 45th annual meeting of the American Society of Clinical Oncology in Orlando, Fla. The study showed a response rate of more than 60% in a single-arm extension cohort of 56 patients conducted to confirm preliminary findings from a 156-patient phase 2 study evaluating overall response with figitumumab when combined with carboplatin and paclitaxel in patients with non-small cell lung cancer.

“As we try to find the right drug to use in the right setting for each patient, we are encouraged by these data, suggesting a relationship between tumor histology and response to figitumumab,” Pfizer Oncology Business Unit SVP clinical development and medical affairs Mace Rothenberg said in a statement. “Given that patients with advanced NSCLC face a poor prognosis, it is important to be able to identify specific patients who may benefit most from different treatment options.”

The company recently started a phase 3 trial of the drug, an anti-insulin growth factor type 1 receptor antibody.

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FDA accepts NDA for epilepsy treatment

BY Allison Cerra

MARLBOROUGH, Mass. Sepracor announced Monday that the Food and Drug Administration has accepted the new drug application for its epilepsy treatment.

Stedesa (eslicarbazepine acetate) has been accepted for filing and is now under formal review. The NDA was submitted Mar. 31 for adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. Meanwhile, the Prescription Drug User Fee Act date for Stedesa is expected to be Jan. 30, 2010, subject to written confirmation, the drug maker said.

Sepracor is seeking approval of Stedesa  for adjunctive therapy with once-daily doses of 800 mg and 1200 mg in the treatment of partial-onset seizures in adults with epilepsy.

“We are very pleased to continue the advancement of Stedesa as a potential new adjunctive treatment for partial-onset epilepsy,” said Adrian Adams, president and CEO Sepracor. “Stedesa represents a significant and near-term opportunity for Sepracor, and the FDA acceptance of the NDA is yet another step forward in one of our near- and mid-term corporate objectives of expanding and advancing our pharmaceutical product pipeline.”

Stedesa, Sepracor said, was studied in three Phase III trials involving more than 1,000 patients in 23 countries. Sepracor acquired the rights to commercialize eslicarbazepine acetate in the U.S. and Canadian markets from BIAL, a privately-held Portuguese pharmaceutical company, in late 2007.

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