Orphan Drug Status
15 Mai 2003 - 9:01AM
UK Regulatory
RNS Number:1121L
K.S. Biomedix Holdings PLC
15 May 2003
Embargoed until 0700 15 May 2003
KS Biomedix Holdings plc Tel: +44 (0)1483 307500
Dr Steven Powell, Chief Executive Officer
Weber Shandwick Square Mile Tel: +44 (0) 20 7067 0700
Kevin Smith/Graham Herring
KS Biomedix Holdings plc
European Commission Grants Orphan Drug Designation to KS Biomedix's KSB303 for
the Treatment of Pancreatic Cancer
Guildford, UK... KS Biomedix Holdings plc ("KSB" or "the Company") (LSE: KSB)
today announced that the European Commission has granted Orphan designation to
the Company's most advanced high affinity antibody product, KSB303, for the
treatment of pancreatic cancer, following a positive opinion from the European
Medicines Evaluation Agency's ("EMEA") Committee of Orphan Medical Products
("COMP").
KSB303 is a high affinity, radiolabelled monoclonal antibody, which is being
developed for a range of cancer indications. KSB has completed a Phase I imaging
study of KSB303 in patients with metastatic colorectal cancer in which the
antibody was well tolerated and demonstrated specific targeting and prolonged
retention at metastatic tumours. A Phase I/II trial of KSB303 in pancreatic
cancer is ongoing in clinical centres in Europe.
Pancreatic cancer represents a significant unmet medical need. The incidence of
pancreatic cancer is approximately 38,000 new cases per year in Europe and
30,000 cases in the USA. The majority of patients present with advanced disease
and, with current therapeutic approaches, the median survival time is only about
six months. The prognosis in these patients is very poor with an overall
long-term survival rate of only 0.4%.
The Orphan Medicinal Product legislation became law in the European Union in
January 2000 and provides 10 years of marketing exclusivity from similar
products in the designated therapeutic indication once marketing approval of the
product has been attained.
Dr Steven Powell, CEO of KS Biomedix Holdings plc, commented: "KSB303 is the
first of our high affinity antibody products to enter the clinic and its
development is consistent with our strategy of targeting niche oncology
indications. We are pleased with its progress and we believe that it has
significant value as a therapeutic for use in pancreatic and colorectal cancer,
areas that are poorly served by current therapies. The award of Orphan status is
a significant milestone in the KSB303 programme and, in addition to marketing
exclusivity on approval, we also hope to benefit from a streamlined regulatory
process that will accelerate the timetable to product launch."
- Ends -
Notes to Editors
KS Biomedix Holdings Plc (Guildford, UK) is a biopharmaceutical company
headquartered in the UK that is developing a late-stage pipeline of drugs for a
range of cancer indications. In addition, it has a number of technology
platforms based on its range of receptor-based targeting technologies one of
which is KSB's super high-affinity monoclonal antibodies (SMAs). The Company has
six active clinical programmes, including TransMID-107RTM for the treatment of
adult, recurrent, inoperable high-grade gliomas (brain tumours) and KSB303, an
anti-CEA antibody for the diagnosis and treatment of cancer.
For further details on KS Biomedix please visit www.ksbiomedix.com
This information is provided by RNS
The company news service from the London Stock Exchange
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