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Biotech / Medical : Kosan BioSciences -- KOSN

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From: nigel bates10/31/2005 10:23:37 AM
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Neutec / HSP90

(nb date of release - I've got a couple of months catching up to do...)

19 September 2005 - Manchester, UK:  NeuTec Pharma plc ('NeuTec') today
announces that it has recruited its first patient in a clinical study in breast
cancer patients. The phase Ib, pharmacokinetic, multi-centre, open label study
will evaluate the safety and efficacy of Mycograb(R) administered in
combination with Docetaxel in metastatic or recurrent breast cancer patients.

According to the American Cancer Society, breast cancer is the most common
cancer among women, except for non-melanoma skin cancers and it is estimated
that in 2005 about 211,240 new cases of invasive breast cancer will be diagnosed
among women in the United States. Breast cancer is the second leading cause of
cancer death in women, exceeded only by lung cancer. The chance that breast
cancer will be responsible for a woman's death is about 1 in 33 (3%). In 2005,
about 40,110 women and 470 men will die from breast cancer in the United States.
Currently there is no curative therapy for metastatic breast cancer despite
early diagnosis, and the five year survival rate for advanced cancers is only
18%.

Mycograb(R) is a human genetically recombinant antibody ('grab') that binds to
heat shock protein 90 ('hsp90') which has been identified as a tumour marker
which appears on the outside of certain cancer cells (as with fungi) and is
needed for cancer cell survival. The growth of cancer cells is particularly
sensitive to the effects of hsp90's inhibition and this anti-cancer activity has
been seen in a series of in vitro studies looking at the killing of human cancer
cell lines.

There have been over 460 papers describing the involvement of hsp90 in the
development of cancer. Consequently, hsp90 proteins are widely being evaluated
as targets for cancer chemotherapy in combination with other drugs and as stand
alone therapy. There are 21 on-going trials, involving a variety of cancers,
using agents based on variants of the chemical hsp90 inhibitor geldanamycin.
Dose-limiting toxicity, however, is a major hurdle in the development of
chemical hsp90 inhibitors. Mycograb(R) differs from all other hsp90 inhibitors
in having been originally developed for the treatment of fungal infections. It
is the subject of an on-going application to the European Medicines Evaluation
Agency ('EMEA') for market authorisation in Europe for the treatment of invasive
candidiasis. It has a unique site of action which is not dependent on
nucleotide displacement and, being a human antibody-based product, is
intrinsically safe.

NeuTec's study is taking place in three centres based in Serbia and Poland and
will involve approximately 20 patients who may have received prior cytotoxic
treatment as adjuvant therapy and have a measurable lesion. Patients will be
administered with six cycles of treatment, three weeks apart. The study's
primary objective is to observe the safety and tolerability of Mycograb(R)
administered in combination with current gold standard therapy and the secondary
objective is to monitor the response rate of the target tumours and overall
survival and progression-free survival through 7 months post treatment.

Prof James Burnie said, 'We already have evidence that Mycograb(R) has
clinical efficacy in patients with invasive candidiasis. We are now further
exploring potential activity of Mycograb(R) in breast cancer as a part of our
ongoing programme of exploring the drug's potential in a range of other
indications.'
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