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Published on 23/05/07 at 03:26pm

Breast cancer patients may be offered chemo-free treatment

Hormone therapy drugs such as AstraZeneca's Zoladex may be as effective as traditional chemotherapy in pre-menopausal breast cancer patients, according to a study from Cancer Research UK.

Researchers for the cancer charity analysed 16 trials involving LHRH agonists and found them to be as effective as conventional chemotherapy for many pre-menopausal breast cancer patients with the added benefit of them being better tolerated by patients. About two thirds of pre-menopausal patients have hormone sensitive breast cancer which equates to around 5,500 women being diagnosed in the UK every year.

This means women, whose breast cancer is hormone sensitive, may not need risk becoming permanently infertile or suffering the unpleasant side effects caused by chemotherapy. LHRH agonists stop the pituitary gland producing luteinising hormone, and so remove the stimulus for the ovaries to make oestrogen. But once the treatment stops the ovarian function usually returns to normal.

Overall 42,000 women are diagnosed with breast cancer every year in the UK. Of these around 80 per cent are over the age of 50.

Kate Law, head of clinical trials at Cancer Research UK, said: "This is a very encouraging finding and suggests breast cancer treatment for some pre-menopausal women could be less devastating while being equally effective as conventional chemotherapy."

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Genaera starts clinical trial of anti-obesity drug

Biopharmaceutical company Genaera has begun dosing in its phase I study of anti-obesity compound trodusquemine which works to decrease appetite and normalize blood sugar.

The study is enrolling healthy overweight and obese volunteers to evaluate the safety, tolerability, and pharmacokinetics of ascending single doses of intravenously administered trodusquemine (MSI- 1436). This ascending single-dose protocol will initially enrol approximately 35 subjects and is expected to be completed in the second half of 2007.

Jack Armstrong, president and CEO of Genaera, said: "What we learn in this first stage of clinical testing will help us understand how MSI-1436 performs in the human body and guide the determination of an optimal therapeutic dose for the larger efficacy trials which follow. The efficiency and quality of this work will be important benchmarks for Genaera moving forward."

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Obecure tests cardiovascular drug with simvastatin

Obecure has launched a phase II clinical trial to evaluate the efficacy of the company's cardiovascular drug candidate in improving the plasma lipid profiles of patients treated with simvastatin.

"It is believed that a low-fat diet can improve the cholesterol lowering effect of statin therapy in dyslipidemic patients. We believe that OBE101's anti-fat craving effect may provide the same benefit and assist patients taking Simvastatin, and further lower their plasma lipids," said Dr Yaffa Beck, CEO of Obecure.

The study will enrol about 30 subjects who are stably treated with simvastatin and randomise them into one of two treatment groups: a treatment arm, which will administer the drug twice daily, and a control arm which will receive a placebo.

The primary endpoints for the study include a statistically significant reduction in LDL levels from baseline in treated patients, as compared to placebo, as well as a significant difference between treatment and placebo in the percentage of patients whose LDL levels are reduced by greater than 10%.

Israel-based Obecure is currently conducting two additional phase II studies using the company's OBE101 drug candidate in the area of weight management.

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Vernalis and Servier begin cancer drug discovery partnership

UK-based specialty bio-pharmaceutical company Vernalis and French pharmaceutical player Servier Research Group have entered into a joint oncology drug discovery collaboration that will last for three years.

The companies hope that the partnership will result in novel therapeutic approaches for treating cancers by speeding up the discovery of innovative compounds with potential use in therapeutic indications with high unmet medical need.

Under the terms of the collaboration, which utilises Vernalis' proprietary drug discovery platform, Vernalis will receive an upfront payment and a share in the downstream success of the product. The terms of this have not been disclosed.

Simon Sturge, CEO of Vernalis, commented: "The collaboration with Servier is an important step for Vernalis and further validates our fragment-based drug discovery platform. This platform is currently being used to progress a number of our research programmes."

Laurent Perret, president of Servier research and development, added: "We are confident that the collaboration with Vernalis will efficiently complement our research activities and help us in reaching our objectives."

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Boehringer Ingelheim slashes price for HIV drug in developing countries

Boehringer Ingelheim has announced a preferential pricing policy that will effectively allow developing countries to buy generic versions of its HIV drug Viramune.

The company now issues short, non-assert declarations which can be given to all generic producers worldwide, prequalified by the WHO, and are free of licence fees or other charges.

Boehringer Ingelheim has also introduced a lower preferential price for original Viramune of $0.60, cutting the costs for Viramune in half compared to the former preferential price. Middle income countries, such Brazil and Thailand, will receive a 90% discount on the price for the treatment in highly industrialised countries, at $1.20 per day.

Dr Alessandro Banchi, chairman of Boehringer Ingelheim, said: "Preferential pricing is the only way how we can meet both conflicting needs in the fight against AIDS: we can refinance our high R&D costs for innovative, new treatments by the established price system in industrialized countries and can offer affordable medicines to patients in poor countries that otherwise cannot afford antiretroviral medication. The patent situation will not stand in the way of poor people who need our medication."

Drug companies that have failed to negotiate a low enough price with some governments have seen their drugs subject to compulsory licenses. Brazil recently issued a compulsory licence for Merck's Sustiva (efavirenz) after price negotiations over the HIV drug broke down, and will now be able to buy generic versions of the drug.

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