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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
For the month of December 2000.
PROTHERICS PLC
(Translation of Registrant's Name Into English)
BEECHFIELD HOUSE
LYME GREEN BUSINESS PARK
MACCLESFIELD CHESHIRE SK11 0JL
ENGLAND
(Address of Principal Executive Offices)
(Indicate by check mark whether the registrant files or will file
annual reports under cover of Form 20-F or Form 40-F.)
Form 20-F [X] Form 40-F [ ]
(Indicate by check mark whether the registrant by furnishing the
information contained in this form is also thereby furnishing the information to
the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of
1934.)
Yes [ ] No [X]
(If "Yes" is marked, indicate below the file number assigned to the
registrant in connection with Rule 12g3-2(b)): 82-_________________.
The Registrant is furnishing a copy of its announcement as reported to
the Company Announcements Office of the London Stock Exchange on November 30,
2000.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the Registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
PROTHERICS PLC
Date: December 13, 2000 By: /s/ Andrew J. Heath
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Andrew J. Heath, M.D., Ph.D.
Chief Executive Officer
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[PROTHERICS LOGO]
30 November 2000
PROTHERICS PLC
ANGIOTENSIN VACCINE ENTERS PHASE II TRIALS FOLLOWING
EVIDENCE OF PROOF OF CONCEPT IN PHASE I
BLOOD PRESSURE REDUCTION FOUND IN NORMAL VOLUNTEERS
Protherics PLC, a UK-based biotechnology company, is pleased to announce that
analysis of results from the Phase I trial of its angiotensin vaccine indicates
that the product was able to lower blood pressure in normal volunteers.
Supported by these encouraging results, the product will now enter Phase II
trials.
In Phase I, the reduction in the blood pressure of the normal volunteers, as
compared to the control subjects who did not receive the vaccine, was
statistically significant (see notes). This result provides strong evidence of
pharmacological proof of concept for the angiotensin vaccine, a unique product
under development for the treatment of high blood pressure (hypertension) and
heart failure.
Protherics has received UK regulatory clearance to undertake Phase II trials for
the angiotensin vaccine. Having recently received its CTX (Clinical Trial
Exemption) for clinical trials in patients, Protherics intends to start the
initial Phase IIa study in December. This stage will involve a total of 24
patients with high blood pressure to establish the preferred dosing schedule for
the vaccine. Once this schedule is determined, Protherics will undertake a
larger Phase IIa trial to further demonstrate the ability of the vaccine to
control blood pressure in patients with hypertension. This programme is expected
to begin in the third quarter next year and take approximately 9 to 12 months to
complete.
Hypertension is one of the most common medical conditions in developed countries
and is a risk factor for developing heart attacks, heart failure, blood vessel
problems or kidney damage. Current treatments are tablet based and require daily
dosing, often for life. The pharmaceutical market for high blood pressure
treatment is the largest single therapeutic sector in the world, with sales
exceeding US $20 billion per annum world-wide.
CHIEF EXECUTIVE ANDREW HEATH COMMENTED:
"It is significant that early trials have been able to provide indications of
proof of concept for our angiotensin vaccine, demonstrating its ability to lower
blood pressure in people. This is an unusually strong foundation from which to
progress to Phase II trials and is another major step forward in building
Protherics' immunotherapeutic pipeline following the recent FDA approval of our
rattlesnake antivenom, CroFAb."
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FOR FURTHER INFORMATION:
Andrew Heath
Chief Executive, Protherics PLC +44 (0) 20 7426 4690
Arthur Rushton
Chief Operating Officer, Protherics PLC +44 (0) 1625 500555
Laura Frost
The Maitland Consultancy +44 (0) 20 7379 5151
NOTES ON PHASE I TRIAL RESULTS
Analysis of the repeat dose Phase I study (PMD3117/002) has shown that the 24
hour blood pressure profile in immunised volunteers receiving a low salt diet
was lower than in control. This effect was more marked during the night time,
when immunised subjects had, on average, a diastolic blood pressure more than
6mmHg lower than control subjects, and this difference was statistically
significant. Producing a similar reduction to that demonstrated in the Phase I
trials in patients with high blood pressure would be clinically beneficial.
BACKGROUND INFORMATION ON HYPERTENSION
Hypertension affects about 20 per cent of the middle-aged adult population with
the frequency of occurrence increasing with age to 50 per cent in the over 65s.
Many patients with high blood pressure fail to reach target levels of reduction
in blood pressure in part due to failure to take prescribed treatment regularly.
A recent UK survey by the Blood Pressure Association showed that half of the
1,500 high blood pressure patients surveyed were not having their blood pressure
adequately controlled while half of the respondents also experienced side
effects from their medication demonstrating the need for better treatments.
Protherics' Angiotensin vaccine is intended to replace or complement existing
treatments by reducing the number and dose of conventional drugs needed by the
patient. This should improve compliance with existing treatments and thereby
increase cost-effectiveness of treatment for this condition.
Protherics PLC
Protherics PLC was formed in September 1999 from the merger of Proteus
International plc and Therapeutic Antibodies Inc. Protherics, an international
biopharmaceutical company, has two platform technologies, the development and
production of immunotherapeutic products, based on its proprietary antibody and
vaccine technologies, and computer aided molecular design.
The Company's ordinary shares are listed on the Official List of the UK Listing
Authority and are traded on the London Stock Exchange.
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An electronic version of this will be available on the Company's website:
http://www.Protherics.com
This release, and oral statements made from time to time by Company
representatives concerning the subject matter hereof, may contain so-called
`forward looking statements'. These statements can be identified by introductory
words such as `expects', `plans', `will', `estimates', `forecasts', `projects',
words of similar meaning, and by the fact that they do not relate strictly to
historical or current facts. Forward-looking statements frequently are
discussing the Company's growth strategy, operating and financial goals, plans
relating to regulatory submissions and approvals and development programs. Many
factors may cause actual results to differ from the Company's forward-looking
statements, including inaccurate assumptions and a broad variety of risks and
uncertainties, some of which are known and others of which are not. Those and
other risks are described in the Company's filings with the Securities and
Exchange Commission, copies of which are available from the SEC or may be
obtained upon request from the Company. No forward-looking statement is a
guarantee of future results or events, and one should avoid placing undue
reliance on such statements.
