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CV247 |
History - CV247 as developed by Dr John Carter MRCVS MB AcA (Veterinary Surgeon). Its formulation was based on over thirty years experience in treating cancer in Cats and Dogs, Dr Carter has demonstrated some interesting anecdotal responses. Each animal was treated at his veterinary surgery in Harrow, Middlesex.
Animals given CV247 were monitored by the named Veterinary Surgeon of the Imperial Cancer Research Fund and the chief Veterinary surgeon of the Ludwig Institute of Cancer research, Andor Sebesteny BVSc Dip BACT MRCVS. In this uncontrolled setting there appeared to be some tumour regression with no reported toxicity.
Dr Carter approached Professor Beverly at the Middlesex hospital to perform a controlled experiment in 50 mice with implanted tumours. In this controlled experiment, tumour regression was also seen.
These encouraging anecdotal results prompted Dr Carter to supply the formulation to human patients with terminal malignancy on a compassionate basis. Patients came to him by word of mouth and were seen in his own practice. Again in this prospective but uncontrolled setting there appeared to be some tumour regression or stabilization without any reported toxicity.
IVY medical chemicals, the registered owner of CV247 sponsored clinical trials at Bedford Hospital starting in 2001 and two human trials have been completed so far:-
Trial one - Does CV247 influence quality of life & malignant progression ?
Publications:
Preliminary phase II results of the
salicylate rich formula CV247 in patients with malignant disease.
Robert James Thomas, Sara Godward, Madeleine M. Williams, Wassif F.
Wassif. Abstract Book of the 27th ESMO
Congress, Sup5, Pg 30.
Preliminary phase II results of the
salicylate rich formula CV247 in patients with malignant disease. Thomas R,
Godward S, Williams M, Wassif W. BOA Annual Scientific
Meeting in association with BASO,
Trial 2 - A randomised double blind phase II study of CV247 versus sodium Salicylate in patients with early prostate cancer.
Introduction - Since the introduction of testing for serum Prostatic Specific Antigen (PSA) the reported incidence of prostate cancer had risen rapidly and this is most prominent in the relatively younger group of men between 55 - 70 years, and those with less aggressive tumour.In this group there is significant debate as to the best treatment, and as less than 5% of the patients with indolent tumours will die of their disease, the vast majority are being over treated with therapies which carry significant toxicities, namely radiotherapy, brachytherapy or surgery. For indolent prostate cancer many physicians recommend a watch and wait strategy. This strategy is often interpreted as “no treatment” and is often unacceptable to the patients once they received the very emotive label of cancer. Furthermore, there is also considerable debate and very little confirmed randomised data for the optional management for relapsing patients, post radical treatment. The general consensus from NICE and WACN guidelines is to adopt a watch and wait policy. This trial, therefore, is open to patients in both these categories.
One mechanism of action of CV247 is blocking the over expression of the COX genes which are integrally involved in the fundamentals of cancer progression, namely; reduced apoptosis (immortality), adjacent organ invasion, development of new blood vessel formation (angiogenesis) and spread to other areas of the body (metastases). Over expression of COX-2 is also associated with other markers of malignancy namely increased activation of tyrosine kinase signalling (e.g. EDF, PDGF SRC & ras). Inhibitors of tyrosine kinase have also been shown to reduce COX-2 expression. Direct inhibition of COX expression is now, understandably, the subject of intensive pre-clinical and clinical research.
CV247 also has antioxidant properties of
Vitamin C and trace mineral essential for the formation of Superoxide Dimutase
(SOD).
Trial
Objectives
1. To investigate the effectiveness and tolerability of CV247 in patients with indolent or relapsing prostate cancer.
2. To compare the effectiveness and tolerability of CV247 with sodium salicylate.
Trial
design
All patient were required to have progressive disease measured by their PSA doubling time and can either have had no previous radical therapy or be relapsing post radical therapy. For the former group the definition of PSA progression is based on at least two PSA’s calculating a doubling time of less than 4 years; for patients post radical therapy the ASTRO definition is adopted (two consecutive increases in PSA from three consecutive analysis > 1.5 ug/dl) .
[1]
Unsatisfactory therapeutic response - This
trial is unusual because the patient and physician may define a satisfactory
response as a reduction in PSA or a prolongation of the doubling time. In this
latter scenario, a decision to withdraw is based on the preferences and
individual circumstances of each patient and clinician, who are both blind to
the treatment arms. For example, one patient may have a high threshold for
stopping the trial and starting hormone therapy, so a small prolongation in
doubling time is acceptable. Another patient may only be comfortable if his PSA
has stabilised or dropped. A Kaplan-Meyer survival curve will be plotted for
each group. To calculate PSADT for PSAa
to PSAb between time (t):
PSAa x t
PSAb - PSAa
Trial
contact To
find out more about these and other trials contact Madeleine Williams at the
Primrose Research Unit, Bedford Hospital. MK42 9DJ.
Email madeline.williams@bedhos.anglox.nhs.uk
Further general information Your doctors and specialist nurses are in an ideal position to give you relevant information on your disease and treatment as they know your individual circumstances. Cancerbackup has a telephone help line ( 0808 800 1234) and a prize winning video available in English, Italian, Urdu, Bengali, Gujarati and Hindi explaining Radiotherapy & Chemotherapy. Cancernet.co.uk has over 500 pages describing cancer, common tests, its management, treatment side effects, tips to alleviate them, advice on fertility, bone health, clinical trials, and practical issues such as travelling, finance, support groups, sexuality, smoking, diet and exercise.
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