The Pharmaceutical Journal
Vol 273 No 7325 p709
13 November 2004

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Novel therapies for breast cancer and infections in GSK’s pipeline

Novel therapies to treat breast cancer, HIV and hepatitis B infections are generating encouraging results for GlaxoSmithKline.

Recent trial data have revealed that lapatinib (GW572016) can stabilise and halt progression of metastatic breast cancer tumours that do not respond to trastuzumab (Herceptin). Lapatinib is a potent inhibitor of both ErbB1 and ErbB2; two receptors frequently over-expressed in human tumours. Phase II clinical trials of lapatinib have been carried out in 41 patients to date, and have shown that metastatic tumours in 17 per cent of patients did not progress with continuing lapatinib therapy at 24 weeks. The trial will continue in a total of 80 patients and phase III trials in patients with advanced metastatic breast cancer have now started.

Another drug being developed by GSK, for treatment of HIV infection, has shown promise in a phase II study designed to evaluate its short-term safety, tolerability and efficacy. The investigational compound 873140 is one of a new class of drugs that block CCR5 receptors to prevent binding and entry of HIV into target cells. Patients showed a dose-dependent decline in blood HIV levels after 10 days of treatment with the compound.

GSK Biologicals, based in Belgium, is expecting approval within the next few months for human use of Fendrix, a novel vaccine under investigation for prevention of hepatitis B in patients with renal insufficiency, and specific high-risk groups including patients who undergo haemodialysis. As well as a hepatitis B antigen, GSK Bio’s vaccine contains a novel adjuvant, AS04, which the company says helps boost the body’s immune system.