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Pharma news from Datamonitor

Published on 26/04/07 at 01:51pm

Gemin X compound effective in leukemia

Gemin X has said its compound that treats acute lymphoblastic leukemia produced positive results in a recent study.

According to the study, GX15-070 demonstrated potent single agent activity against acute lymphoblastic leukemia (ALL) blast cells, and also enhanced chemosensitivity and was synergistic with cytotoxic drugs. GX15-070 is a small molecule specifically designed to inhibit all relevant members of the Bcl-2 protein family, a validated cancer target, restoring the natural cell death process of apoptosis.

"GX15-070 is an appropriate candidate for ALL treatment because the imbalanced expression of Bcl-2 family proteins in this cancer leads to impaired apoptosis," said Gordon Shore, chief scientific officer of Gemin X.

"Additionally, this study further upholds what we already have observed about our lead candidate's utility as a single agent and in combination with other therapies."

Gemin X is currently conducting several clinical trials of GX15-070 in multiple cancer types as a combination therapy and as a single agent. In phase I studies, GX15-070 was well-tolerated and resulted in clinical and biological activity.

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Hormone therapy linked to increased incidence of ovarian cancer

A large study conducted in the UK has demonstrated that women who take hormone replacement therapy are more likely to be diagnosed with ovarian cancer and to die of the disease.

Results from the study, show that over five years there is one extra case of ovarian cancer in every 2,500 women who take HRT. And for every 3,300 women who take HRT, there will be one additional death from ovarian cancer.

The researchers, who are largely funded by Cancer Research UK, estimate that use of HRT since 1991 has resulted in an extra 1,300 cases and 1,000 deaths from ovarian cancer. The study also suggests that a woman's risk of ovarian cancer returns to a normal level within a few years of stopping HRT. The research showed that the risk of ovarian cancer was increased regardless of which kind of HRT the women were taking.

Previous results from the study have linked the use of HRT with breast and endometrial cancer, a cancer of the womb lining.

The overall incidence of these three cancers in women who take HRT is 31 cases for every 1,000 women over five years. This compares with 19 cases in women who have never taken HRT.

"This study clearly shows that taking HRT increases a woman's chance of getting ovarian cancer and her chances of dying from the disease," said professor John Toy, Cancer Research UK's medical director.

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Gilead reports positive data for cystic fibrosis antibiotic

Gilead Sciences has reported positive results from a phase III study evaluating inhaled antibiotic aztreonam lysine in patients with cystic fibrosis who have pulmonary Pseudomonas aeruginosa.

In the study, a 28-day treatment course of aztreonam lysine significantly improved the time to need for inhaled or intravenous antibiotics versus placebo. All patients received an initial 28 days of treatment with tobramycin inhalation solution prior to receiving study drug. Aztreonam lysine for inhalation was well tolerated and patients also experienced significant improvements in pulmonary function and respiratory symptoms.

The study was designed to assess the safety and efficacy of a 28-day treatment course with aztreonam lysine for inhalation following a 28-day treatment course of tobramycin inhalation solution in people with cystic fibrosis who have pulmonary Pseudomonas aeruginosa.

"Pulmonary pseudomonal infection remains the leading cause of sickness and death in people with cystic fibrosis," said Karen McCoy, chief of the Division of Pediatric Pulmonology.

Gilead plans to submit a new drug application for aztreonam lysine for inhalation for the treatment of people with cystic fibrosis who have pulmonary Pseudomonas aeruginosa to the FDA in the second half of 2007.

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