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R&D news in brief

Our weekly round-up of R&D news in brief

HIV-type predicts survival
The case to support early and accurate diagnosis of the various forms of HIV infection was bolstered, after research at Johns Hopkins University revealed that people infected with HIV subtype D are likely to see their disease progress more rapidly than those with subtype A infections. Therefore, people with HIV subtype D infections are likely to die sooner, according to data which revealed that in 300 men and women examined in Uganda between 1995 and 2001, average survival (years from time of infection) for subtype A was 8.8 years, compared with just 6.9 years for subtype D. Survival for cases of co-infection with both HIV subtypes was reduced further to 5.8 years. It is thought that subtype D binds to both CCR5 and CXCR4 receptors, whereas subtype A binds only to the former. The data was presented at the 2006 Conference on Retroviruses and Opportunistic Infections.

Lancet: urgent change needed in early trials
Following the high profile case of six men left fighting for their lives at Northwick Park Hospital after taking an experimental antibody-based drug, medical journal the Lancet has called for ìurgent changeî in the approval and regulatory processes governing the operation of such early-stage trials. Despite investigations by the Medicines and Healthcare products Regulatory Agency, which so far have found that all safety conventions were adhered to by the trial operators, the Lancet has said that improvements and changes are needed in the way that phase I trials are permitted to run, in order to avoid a repeat of the Northwick Park trial disaster. Such trials are permitted to run only on the basis that any serious, or life-threatening, side effects evident in animal trials (preclinical) are understood and controlled; however, the severe inflammatory reactions seen in six men having taken TeGenero AG's TGN1412 were reportedly not seen in any animal models.

New asthma inhaler - more 'user-friendly'
One of a new generation of so-called `bulk reservoir' dry powder inhaler (DPI) devices which is claimed to be reliable and more user-friendly than older devices, is set to be unveiled at the upcoming Respiratory Drug Delivery conference, in Florida (April 23-27). Developers of the NEXT device - Cambridge Consultants and Chiesi Farmaceutici - have said that they designed it in accordance with the `wishes' of extensive user group research. It features breath activation, a reliable dose counter and holds up to 120 doses in a device style that is ìrobustî and ìmodernî. The firms claim that it guarantees an accurate and consistent dose delivery.

Evista beats tamoxifen in 19,000 patient study
Eli Lilly & Co has been bolstered by trial results, which were branded by the National Cancer Institute as ìgood news for womenî, and showed its osteoporosis drug Evista (raloxifene) to outstrip AstraZeneca's Gold Standard therapy Nolvadex (tamoxifen) in reducing the risk of breast cancer in older women. As part of a 19,000 patient-strong trial, raloxifene matched tamoxifen in reducing risk in post-menopausal women by approximately 50 per cent, yet Lilly's drug was linked to 36 per cent fewer uterine cancers and 29 per cent fewer blood clots than tamoxifen. Rates of heart attack and stroke were similar in both groups, however researchers said the findings should reassure women who know they have a high risk of breast cancer yet were reluctant to take tamoxifen due to the known array of potential side effects. Despite the good news however, Lilly's share price was seemingly unaffected with one analyst putting it down to a market that was seeking `something new', above and beyond an enhancement.

30th September 2008

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