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Antisoma PLC (~292)

  Print      Mail a friend       Annual reports

Friday 10 November, 2000

Antisoma PLC

1st Quarter Results

Antisoma PLC
10 November 2000

Antisoma plc reports Q1 results

10 November 2000, London,UK Antisoma plc (LSE:ASM, EASD:ASOM) today announces
results for the quarter ended 30 September 2000.


  * Thioplatin, a novel platinum-based targeted anti-cancer therapy, joins
    development pipeline
  * Theragyn Phase III study recruitment expected to complete first quarter
  * £9 million gross raised in private placement of new ordinary shares
  * Losses for the period reduced to £1.7 million (Q1 1999: £2.1 million)

Dr Barry Price, Chairman, commented:

'We are very pleased that recruitment in the Theragyn Phase III study has
restarted. Patient accrual is picking up and we anticipate that results from
the study will be available in the second half of 2002. Since the end of the
first quarter, we have taken a significant step towards one of our principal
objectives for the year, namely the broadening and strengthening of Antisoma's
development pipeline with the addition of Thioplatin. We believe this shows we
are a partner of choice for the development of novel cancer therapies.'

For further information and press releases, please visit the Company's web
site at or contact:

Antisoma plc
Glyn Edwards, Chief Executive Officer           Tel: +44 (0)20 8799 8200

Val Tate, Investor Relations

Financial Dynamics
Jonathan Birt / Sarah Mehanna               Tel: +44 (0)20 7831 3113

This quarterly report contains forward-looking statements that involve risks
and uncertainties. No assurances can be given that such statements can be

Chairman's report


Although it is only eight weeks since the publication of the annual report, in
that time we have taken a significant step towards one of our principal
objectives for the year, namely the broadening and strengthening of Antisoma's
development pipeline. On 30 October, we announced the in-licensing of
Thioplatin, an innovative, tumour targeting version of a platin. Unlike
existing platinum-based drugs, Thioplatin is only 'switched on' by the acidic
conditions typically found in tumours, leaving healthy tissues essentially
undamaged. Thioplatin is expected to enter clinical studies within the next
two years.

Theragyn (pemtumomab)

Antisoma's lead product, Theragyn (generic name pemtumomab), continues to make
progress. Patient accrual into the Phase III (SMART) study in ovarian cancer
patients has been building following the temporary halt in recruitment earlier
this year. Early in July, Antisoma's SMART study Independent Safety Committee
strongly recommended that recruitment into the SMART study be continued.
Following discussions with the appropriate regulatory authorities, recruitment
was resumed in July and is projected to complete in the first quarter of 2001.
We still anticipate that results from the study will be available in the
second half of 2002.

Recruitment into the pilot Phase II gastric cancer study is now expected to be
complete in 2001. The Company is actively considering a second study following
revised eligibility criteria for patients entering the study with a view to
more rapid patient accrual than has been possible to date.


Therex is a humanised monoclonal antibody under development, initially for the
treatment of breast cancer. Antisoma has applied for patent protection
covering the humanised HMFG1 monoclonal antibody, which is the basis of
Therex, and has received notice of allowance from the US patent authorities.
The claims of the patent cover the humanised HMFG1 antibody and certain
methods of production. The projected expiry of the patent is in 2018.

Since the product was adopted from the ICRF earlier this year, we have
concentrated on manufacturing scale-up as the anticipated dose regimen is
significantly greater than for Theragyn. Development, focused on the
establishment of stable cell lines that secrete high yields of the antibody,
has been slower than anticipated. In addition, we decided that the first
production batch should be significantly larger than preliminary estimates.
Increased production capacity has now been secured, leading to a revised
estimate of mid-2002 for receiving clinical material for the projected Phase
IIa study.


Work on AngioMab is concentrating on identifying lead product candidates and
scale-up of manufacture ahead of starting clinical studies. We anticipate that
the first AngioMab product into the clinic will be a radiolabelled version of
the antibody to be used to treat glioma, a form of brain cancer. Clinical
studies are projected to start by the end of 2001.


In August 2000 the Company raised £8.7 million net of expenses through the
issue of 7.68 million new ordinary shares at 117p per share. Continental
European investors represented over 30% of the new money received. After the
quarter end, the Company received a further £2.6 million on the exercise of an
option by Altium Capital Limited ('Altium') to purchase 2.2 million new
ordinary shares at an exercise price of 117p per share. Altium (previously
Apax Partners & Co. Corporate Finance Limited) were granted the option in
December 1996 in connection with a private fund raising completed on
Antisoma's behalf.

New Director of Clinical Development

At the beginning of October, we announced the appointment of Dr Tony Whitehead
as Director of Clinical Development. Tony joined us from Pfizer Ltd, where he
has been Medical Director since 1995 and was involved in the successful UK
development of five major new drugs. He brings experience of running major
multinational clinical studies, as well as broad expertise in regulatory and
medical affairs.

We were sorry that Dr Luiz Porto, who Tony replaces, is leaving the Company
for health reasons. Luiz has played a central role in the growth of Antisoma.
On behalf of the Board and his colleagues, I would like to thank Luiz Porto
for his outstanding contribution to the Company over the past four years.

Financial review

Three months ended 30 September 2000

Revenue received in the period totalled £0.8m (Q1 1999: £nil). This was the
third development milestone payment due under the Development and Licence
agreement signed in October 1999 with Abbott Laboratories ('Abbott'). As a
consequence of this income and increased interest income from cash on deposit,
the losses for the period were reduced to £1.7m (Q1 1999: £2.1m). Net
operating expenses were £2.7m (Q1 1999: £2.1m). Operating expenses include
research and development spending of £2.0m (Q1 1999: £1.5m). The increased
spend in research and development reflects the increased number of products in
the development pipeline.

Liquidity and financial condition

In August 2000 the Company raised £9.0m, before expenses of £0.3m, through the
issue of 7.68 million new ordinary shares priced at 117p per share. Cash in
the bank and held in short term investments totalled £12.2m at 30 September
2000, compared to £4.4m at 30 June 2000 and £1.8m at 30 September 1999. The
net cash outflow from operating activities was £1.1m in Q1 (Q1 1999: £2.0m).
In October, after the end of the quarter, a further £2.6m was received
following the exercise of an option by Altium to purchase 2.2 million ordinary
shares at an exercise price of 117p per share. Following the issue of these
shares on 7 November 2000, the Company has 87,553,298 ordinary shares in

Creditors have increased to £3.4m from £1.1m as at 30 September 1999 and £2.5m
as at 30 June 2000. The increase in creditors since September 1999 is largely
due to the receipt of advance funding in respect of the Theragyn clinical
trials and to a provision of £166,000 (30 June 2000: £122,000; 30 September
1999: £11,000) for employers' national insurance on share options issued on or
after 6 April 1999. The further increase in creditors from 30 June 2000 is due
to a general increase in activity.


The Theragyn Phase III ovarian study is now firmly back on track, and we will
now concentrate on speeding up development of the growing number of products
in the pipeline. Thioplatin is the first of several novel cancer therapies we
intend to add to our development pipeline to build shareholder value through
product acquisition. I look forward to reporting further progress for the
second quarter.

Dr Barry Price
9 November 2000

Antisoma plc

Consolidated profit and loss account
for the three months ended 30 September 2000
                                      3 months        3 months            Year
                                         ended           ended           ended
                                  30 September    30 September         30 June
                                          2000            1999            2000
                                     Unaudited       Unaudited         Audited
                                         £'000           £'000           £'000
Revenue                                    826               -           1,543
Net operating expenses                 (2,652)         (2,098)         (9,616)

Operating loss                         (1,826)         (2,098)         (8,073)
Interest receivable                        145              29             224
Interest payable and similar              (14)            (16)            (69)

Loss on ordinary activities            (1,695)         (2,085)         (7,918)
before and after taxation and
retained loss for the period

Loss per 1p share
Basic and diluted                        2.0 p           2.9 p          10.6 p

Weighted average number of              82,685          71,565          74,858
shares (000's)

Consolidated balance sheet
at 30 September 2000
                             30 September       30 September            30 June
                                     2000               1999               2000
                                Unaudited          Unaudited            Audited
                                    £'000              £'000              £'000
Tangible fixed assets                 400                380                421
Current assets
Debtors                             1,511                335              1,268
Short term investments             11,597              1,600              4,250
Cash at bank and in                   553                216                173

                                   13,661              2,151              5,691
Creditors: amounts                (3,368)            (1,132)            (2,511)
falling due within one

Net current assets                 10,293              1,019              3,180
Creditors: amounts                   (84)               (53)               (65)
falling due after more
than one year

Net assets                         10,609              1,346              3,536

Capital and reserves
Called up share                     5,185                716              5,108
Share premium account              28,548             16,226             19,857
Other reserves                      4,300              4,300              4,300
Profit and loss                  (27,424)           (19,896)           (25,729)

Total shareholders'                10,609              1,346              3,536

Shareholders' funds
analysed as:
Equity shareholders'                6,277              1,346              (796)
Non-equity                          4,332                  -              4,332
shareholders' funds

                                   10,609              1,346              3,536

Consolidated cash flow statement
For the three months ended 30 September 2000
                                   3 months          3 months              Year
                                      ended             ended             ended
                               30 September      30 September           30 June
                                       2000              1999              2000
                                  Unaudited         Unaudited           Audited
                                      £'000             £'000             £'000
Net cash outflow from               (1,063)           (2,008)           (7,151)
operating activities

Returns on investments
and servicing of finance
Interest received                       116                29               224
Interest paid                             -              (16)                 -
Interest paid on finance               (14)                 -              (69)

Net cash inflow from                    102                13               155
returns on investments
and servicing of finance

Capital expenditure and
financial investment
Purchase of tangible                   (37)               (1)             (196)
fixed assets

Net cash outflow before               (998)           (1,996)           (7,192)
management of liquid
resources and financing

Management of liquid
Purchase of current asset           (7,347)             2,060             (590)
Issue of shares                       8,986                 -             8,046
Expenses paid in                      (218)                 -              (23)
connection with share
Repayment of principal                 (43)              (73)             (293)
under finance leases

                                      8,725              (73)             7,730

Increase/(decrease) in                  380               (9)              (52)

Notes to the financial statements

 1. Basis of reporting

    The quarterly financial statements have been prepared in accordance with
    UK Generally Accepted Accounting Principles ('UK GAAP') on the basis of
    the accounting policies set out in the Group's 2000 statutory accounts.
    The statements were approved by the Board of Directors on 9 November 2000
    and are unaudited.

    The financial information contained in this announcement does not
    constitute statutory accounts within the meaning of Section 240 of the
    Companies Act 1985. The figures for the year ended 30 June 2000 have been
    extracted from the statutory accounts which have been filed with the
    Registrar of Companies and which are available on request from the Company
    Secretary at Antisoma plc, West Africa House, Hanger Lane, Ealing, London
    W5 3QR. The auditors' report on those accounts was unqualified and did not
    contain any statement under section 237(2) or section 237(3) of the
    Companies Act 1985.

 2. Net operating expenses
                                 3 months            3 months        Year
                                    ended               ended        ended
                             30 September        30 September        30 June
                                     2000                1999         2000
                                Unaudited           Unaudited       Audited
                                    £'000               £'000        £'000
    Administrative                    625                 557        3,144
    Research and                    2,027               1,541        6,472
    development -
    current year

    Net operating                   2,652               2,098        9,616

    Administrative expenses include a charge for employers' national insurance
    arising on share options issued on or after 6 April 1999 of £42,000 (1999:
    £11,000). The total provision held within creditors is £166,000 (1999: £

 3. Reconciliation to International Accounting Standards
    The Company's consolidated quarterly statement has been prepared under UK
    GAAP which differs in certain respects from International Accounting
    Standards ('IAS'). The principal difference between UK GAAP and IAS that
    affects the Group is set out below.

    Cash flow statement
    Under UK GAAP, cash does not include short term deposits and investments
    which cannot be withdrawn without notice and without incurring a penalty.
    Such items are shown as short term investments. Under IAS, deposits with a
    maturity of three months or less at inception and which are readily
    convertible to a known amount of cash, are included as cash and cash
    equivalents. Additionally, IAS requires only three categories of cash flow
    activity to be reported: operating, investing and financing. The table
    below sets out the effect of differences between UK GAAP and IAS and
    provides the relevant disclosures required.

                               3 months            3 months                Year
                                  ended               ended               ended
                           30 September        30 September             30 June
                                   2000                1999                2000
                              Unaudited           Unaudited             Audited
                                  £'000               £'000               £'000
Under IAS:
Operating cash                  (1,063)             (2,008)             (7,151)

Investing cash                     (37)                 (1)               (196)

Financing cash                    8,827                (60)               7,885

Changes in cash                     380                 (9)                (52)
under UK GAAP
Adjustment for                    7,347             (2,060)                 590

Changes in cash                   7,727             (2,069)                 538
and cash
under IAS   

Notes to the Editor

Company profile

Antisoma is a biopharmaceutical company focused on cancer drug development.
The Company's shares are traded on EASDAQ, the pan-European stock exchange,
and on the London Stock Exchange, where they are included in the TechMARK
All-share index. Established in 1988, Antisoma has in-licensed much of its
intellectual property, including clinical development candidates Theragyn
(pemtumomab) and Therex, from cancer research, and other academic,
institutions. Theragyn is in a Phase III study in ovarian cancer and a Phase
II study in advanced gastric cancer. Therex is completing a Phase I study in
breast cancer. There are five other development programmes.


Antisoma fills its development pipeline by acquiring promising early stage
cancer products from both academic and commercial institutions rather than
from in-house research. Antisoma's core activity is the management of
pre-clinical and clinical development to demonstrate the safety and efficacy
of drug candidates. Pharmaceutical partners will complete clinical
development, filing for regulatory approval and marketing. This strategy is
demonstrated by the progress of Antisoma's lead product, Theragyn
(pemtumomab), from an in-licensed product candidate into a Phase III study.
Antisoma has signed an exclusive agreement with Abbott Laboratories to
complete clinical studies and to commercialise the product worldwide.

Clinical pipeline

Theragyn (pemtumomab) is a monoclonal antibody targeting intra-abdominal
epithelial cancers to deliver radioactivity. Long-term follow up of women,
treated with Theragyn whilst in remission following initial surgery and
chemotherapy enrolled in a Phase II study, indicates encouraging data. 81%
treated women have survived five years or more. This compares to a published
five-year survival rate of 55% for a historical control group. Now in a Phase
III study recruiting 300 women, Theragyn has US FDA orphan drug designation as
an adjuvant treatment for ovarian cancer, conferring a seven-year market
exclusivity period, if approved. Antisoma estimates that the total ovarian
cancer market in North America, Europe and Japan is worth around US$850
million per year. Therex, a humanised monoclonal antibody, was adopted from
the ICRF who conducted a Phase I study showing it to be well tolerated. It
will be developed initially as a potential therapy for advanced breast cancer.

Development pipeline

TheraFab is a radioactive antibody that will initially be tested in clinical
studies as a treatment for lung cancer in combination with external beam
radiotherapy. The AngioMab programme, a potential treatment for most solid
tumours, employs a monoclonal antibody to target and destroy newly formed
blood vessels that feed rapid cancer growth. The Targeted Apoptosis programme
aims to push cancer cells growing out of control into the natural cell death
cycle of apoptosis. It is potentially non-toxic and a gentler way to kill
cancer. The programme could produce several candidates. Thioplatin is a novel,
platinum-based anti-cancer therapy which is activated by the acidic conditions
found at the site of a tumour. Therex was the first candidate out of the
Immunotherapy programme. Another antibody, potentially of use in colorectal
cancer, is being assessed in a collaborative development programme.

Clinical pipeline

Antisoma has two products currently in clinical development, Theragyn and
Therex. Both are based on monoclonal antibodies that specifically target and
bind to cancer cells, potentially limiting the side-effects experienced by the

Theragyn (pemtumomab) in ovarian cancer

Theragyn is a murine monoclonal antibody capable of conjugation to the
radioisotope Yttrium-90. The antibody is specific for PEM, a marker
overexpressed on the surface of epithelial tumour cells including ovarian,
gastric, pancreatic, colorectal, breast and lung. This product was originally
developed by the ICRF whose scientists carried out a long-term Phase II study
treating 52 women with ovarian cancer, many with late-stage disease, with
Theragyn. Their study identified a subgroup of women who were in remission at
the time of Theragyn treatment that responded well to treatment.

Ovarian cancer is the second most common gynaecological cancer. Survival rates
are poor because the majority of women present with advanced disease. Antisoma
is developing Theragyn as an additional treatment for ovarian cancer following
initial surgery and chemotherapy. While technically these women may be in
remission, with no detectable disease, a high proportion of them relapse.
Treatment with a single intraperitoneal dose of Theragyn is thought to target
and destroy any cancer cells remaining after surgery and chemotherapy, thus
preventing or delaying relapse.

Antisoma is conducting a randomised, prospective Phase III study in over 50
centres in North America, Europe and Australia. The SMART study is designed to
demonstrate Theragyn's potential survival advantage for treated women and
safety profile, and to provide data suitable for a registration submission in
the US and Europe. The study will enrol 300 patients, half of whom will
receive active treatment. Follow up will average 2.5 years, the primary
endpoint being survival.

On 29 October 1999, Antisoma concluded a major licensing agreement with Abbott
granting a worldwide exclusive license to develop, market and sell Theragyn.
The deal has the potential to exceed US$100 million in total for equity,
development costs and milestones. The Company will also receive royalties as a
percentage of net sales.

Theragyn (pemtumomab) in other indications

Results from studies to date treating ovarian cancer patients suggest that
Theragyn may be effective in treating the intra-abdominal spread of other
epithelial cancers such as gastric, colorectal, uterine and pancreatic.

Antisoma is conducting a pilot Phase II study for Theragyn with advanced
gastric cancer patients. Worldwide, gastric cancer is the second most common
cancer after lung cancer. Approximately 90% of patients die within five years
of diagnosis because the majority of tumours are not detected until they have
spread. Antisoma estimates that there are over 100,000 advanced gastric cancer
patients who could be treated with Theragyn annually in North America, Europe
and Japan.

As part of the development and commercialisation agreement, Abbott has rights
to develop Theragyn for other intra-abdominal indications including gastric,
pancreatic, uterine and colorectal cancers. Abbott also agreed to support
Antisoma's ongoing pilot Phase II study in gastric cancer.


Therex, based on a humanised form of the Theragyn monoclonal antibody, is
under development initially to treat women with breast cancer who have
relapsed following first line treatment. Nearly 500,000 women are diagnosed
with breast cancer every year in North America, Europe and Japan. The antibody
targets most epithelial cancer cells. Since many breast cancers are
epithelial, Antisoma estimates that Therex could treat over 112,000 cases
annually. This would indicate a total market potential in excess of US$1

The Breast Cancer Biology Group at Guy's Hospital, funded by the ICRF who
originally developed Therex, conducted a Phase I clinical study to test the
product's safety and tolerability following repeat administration. Results
from 18 patients following treatment for primary breast cancer indicate that
the drug is well tolerated at the doses given. Antisoma is now progressing
Therex's development into a Phase IIa clinical study and has contracted with
Lonza Biologics to provide clinical-grade material for the study.

Development pipeline


TheraFab, derived from the same monoclonal antibody as Theragyn, is designed
for intravenous administration to treat some of the more common cancers of
epithelial origin, including lung and breast. TheraFab will be developed in
combination with external beam radiotherapy using Antisoma-owned methodology
called RACER (Radioactive Antibody Combined with External beam Radiotherapy)
as a way of delivering a high dose of radiation directly to cancer cells while
reducing damage to healthy, surrounding tissue.

In the first instance, TheraFab and RACER will be explored in the treatment of
lung cancer, where two-thirds of patients present with extensive disease.
Radiotherapy is usually used in conjunction with chemotherapy to improve local
control and extend survival. Over half a million new cases of lung cancer are
diagnosed annually in the world's three major markets.

BioInvent, Sweden, is producing clinical-grade material for a Phase I
biodistribution study due to start with lung cancer patients by the end of the
year 2000.


Rapidly-expanding tumours induce the formation of their own blood supplies.
Antisoma has in-licensed a monoclonal antibody BC-1, specifically targeting a
protein produced by these new blood vessels. Therapies based on BC-1, acting
alone or carrying a killing agent, will be developed to interrupt the tumour's
blood supply and directly or indirectly to cause its death. Since essentially
all solid tumours, including those of the brain, lung, breast, colon and
prostate, need their own blood supply, products based on this antibody have
the potential to treat many different cancers.

The first product candidate is likely to be a radiolabelled antibody to treat
glioblastoma, the commonest form of brain tumour, in combination with RACER
technology. Glioblastomas produce high levels of the BC-1 target protein and
grow into adjacent brain tissues, causing neurological damage. Most
glioblastoma patients survive for less than 2 years after diagnosis. So far as
the Company is aware, there are currently no treatments that improve survival
rates. Therefore, many of these patients would be eligible for AngioMab

Targeted apoptosis

One of the major goals in cancer drug development is to eliminate the side
effects currently associated with most forms of therapy whilst retaining
tumour-killing potential. In Targeted Apoptosis, an antibody for tumour
specificity is combined with the enzyme DNase, a natural enzyme that is found
in blood as part of the body's cleaning mechanism but, once inside the cell
nucleus, it will trigger cell death.

It is essential that the targeting antibody is internalised, which we know to
be the case for Antisoma's targeting antibody, HMFG1. We also have shown that
DNase is highly toxic when injected directly into isolated tumour cells,
killing the cells by inducing apoptosis, which causes the cells to break down
into small particles that could be cleared by natural scavenger cells. This
may avoid the significant inflammatory responses, known to be
life-threatening, that are experienced by some cancer patients treated with
conventional therapies. Further in vitro experiments confirmed that, whilst
neither the antibody nor the enzyme alone was toxic, in combination they show
rapid cell killing.

More than one potential therapy could be developed out of this programme,
using either an alternative antibody to target a specific cancer type or a
different apoptosis triggering enzyme.


Thioplatin is a tumour targeting version of a platin, the 'gold standard',
platinum-based drug class that forms the cornerstone of cancer treatments
against a range of solid tumours, including lung, ovarian and testicular
cancers. Although effective, the therapeutic dose for current platinum-based
drugs is limited by potentially serious side effects, including damage to the
kidneys and small intestine.

Thioplatin, which was developed at the German Cancer Research Centre in
Heidelberg, is only 'switched on' by the acidic conditions typically found in
tumours, leaving healthy tissues essentially undamaged. Experiments using
Thioplatin in isolated tumour cells and in animal models have shown that,
whilst its efficacy is similar to that of the widely-used platinum-based drug
cisplatin, its toxicity is strongly reduced. This indicates that it may be
possible to give Thioplatin in higher doses than conventional platinum-based
drugs, thereby potentially increasing the cancer-killing effect.

Platinum-based therapies are amongst the most successful anti-cancer therapies
on the market. In 1999, the combined sales for three of the four branded
platinum compounds were in excess of US $820 million.


a d v e r t i s e m e n t