The idea of creating a company to complete the development of CV247 and exploit its potential arose at a meeting of John Carter’s associates, advisors, and consultants. One such subject was the programme necessary to undertake an initial study of CV247 in Human patients. During discussion of the details of such a study it became apparent that not withstanding the potential of Human Studies, John Carter was already well on the way to completing an initial proof of principle study in dogs, having treated, with apparently good results (through independent review), c25 dogs with proven evidence of cancer by histology.
Advice was taken from; a variety of advisers among which were: the statutory authorities, on what requirements the medicine would need to meet to obtain the necessary licences, from Corporate Advisers on the procedure to follow, from a Stockbroker to gauge potential market acceptance. All advice was very positive and first a limited company – “Ivy Medical Chemicals” was formed with directors drawn from previous advisers with the appropriate professional expertise needed operate the company.
Dr Duffield who had been advising Mr Carter separately joined the Board at this time. Following on from initial advice received the company created the necessary research and development plans, business plans, cash flow projections etc and with professional advice a prospectus was developed for an offering to potential share holders on the OFEX market. A gross £1.5m was raised on the offer and Ivy Medical Chemicals plc was established with Dr. Duffield as Managing Director, and John Carter as Chairman.
In the first year of operation IMC undertook a series of fundamental projects necessary to take the product forward. These were as follows:
- evolved a system of drug delivery
- developed a manufacturing system
- developed of quality assessment programme
- initiated a drug stability test programme
- completed necessary searches to advanced Patent protection for CV 247
- completed Clinical study CV 247 treatment of c50 dogs suffering from cancer.
This work was sufficient to enable Ivy to make an application to the veterinary regulatory authorities for a provisional market authorisation. In the response received Ivy were required to undertake a further study of 50 animals suffering from cancer treated wherever possible by independent Veterinary surgeons. Additionally the authorities made it clear to Ivy that any future application would need to be supported by the effect of the treatment on healthy animals from the target species.
Whilst working exclusively on the animal program interest in potential Human treatments continued to arise. Ivy was introduced to the consultant Oncologist from the Primrose Oncology Unit at Bedford Hospital who agreed to conduct an initial study in a range of cancers including colo-rectal, prostate and ovarian. The necessary clinical trial approval was obtained and 37 Patients were recruited, the treatment was well tolerated and the results are recorded separately.
Results were sufficiently encouraging for a further controlled study into early stage prostate cancer to be promulgated. Commercially Ivy negotiated an agreement with a private company to advance this study. The study was a blinded study comparing the effect of treatment with CV 247 against treatment with one of the principle ingredients of CV 247, sodium salicylate. Over 100 patients were recruited and the when available the results of the study will be separately reported on this web site.
Throughout this period a number of patients suffering from a variety of late stage cancers, had been given CV 247 on compassionate grounds through Mr Carter’s charity , The Carter Compassionate Trust, as a potential therapeutic treatment. It was noticed as in the case with the animal patients being treated that there were seemingly a number of cases where the well being of the patient or their “quality of life” improved as determined by independent medical assessment . Some of these patients were under treatment with a Hospice in the same catchment area, and patient reports interested their clinical Director in the effect of CV 247. Following an increasing involvement in the compassionate program interest culminated in an open-ended study being funded to explore the potential of using CV 247 in a palliative form. This study has concluded and results can be found elsewhere on this web site.
Meanwhile the animal programme continued, the 50 animal studies, shared by Mr Carter and two independent Veterinary Surgeons, were completed, the separate study into the effect on normal animals was concluded and a separate application to veterinary authority was made in 2006. The regulatory authority governing animal affairs responded in April 2007 and a meeting was held shortly after to discuss outstanding issues. Although it is considered that the studies carried out to date on dogs suffering from cancer have shown both efficacy and safety of CV 247 Ivy was required to carry out further clinical work to satisfy the European regulatory requirement.
Professor Andor Sebesteny, whose involvement with CV247 dated back to the 1980’s and who was the involved in UK dog trials as the named veterinary surgeon, organised a similar dog trial in Hungary. As a result of this trial, CV247 was granted a licence in Hungary for dogs as a substance with Therapeutic effect. A joint venture was set up in Hungary called Ad Astra-Ivy Medical Chemicals Kft to market CV247 In early 2009 Professor Sebesteny oversaw a study on rats at theSemmelweiss University in Budapest in which the antioxidant effects of CV 247 was conclusively demonstrated. Kidney damage caused by a single injected heavy dose of cisplatin on histological evaluation appeared to have considerably decreased when it was followed by CV 247 treatment.
In 2008 work has also been done by Dr Ioannis Papasotiriou of a Greek research company called Research Genetic Cancer Centre (RGCC) on human cell cultures of malignant tumours which when treated with CV247 exhibited signs of antitumour effect. Comparisons were made between CV247 and two of its components, sodium salicylate and vitamin C which indicated that the combination had greater effect on colon and breast cancer cells than its individual components on their own. Dr Papasitiriou also studied the effect of CV247 in conjunction with cisplatin which suggested the synergism of CV 247 and cytotoxic drugs used in chemotherapy.