A cervical cancer treatment originated in Kenya is set for a decisive research phase in Australia and New Zealand. The treatment, a combination of two HIV drugs, will from January be tested on 36 volunteers with early cervical cancer.
The one-year clinical trials will be testing whether the vaginal ointment is able to treat or cure cervical cancer in the early stages.
Sponsored by a New Zealand pharmaceutical company, the trials will also assess the effectiveness, safety and tolerability of the treatment.
An application to the Australian New Zealand Clinical Trials Registry shows the study will be recruiting women aged between 25-45 in the two countries.
The first human trials on the concept had been carried out at Kenyatta National Hospital (KNH), by Kenyan and UK researchers with results described as a wild success.
Researchers Dr Lynne and Dr Ian Hampson of University of Manchester, UK, and Dr Innocent Orora Maranga of KNH had put 40 cervical cancer patients on HIV drug lopinavir for two weeks.
When tested for cancer after three months, more than 90 per cent of the patients were found to have been cured of the disease. Announcing the results on March 5, 2014, suspended KNH CEO Lily Koros said this was a major breakthrough for the country, the hospital and Kenyan women.
“The message today is not just about mourning and despair; we stand surrounded by heroes who have identified a solution for cervical cancer,” Koros had told a press conference.
Kenyan researchers Dr Maranga and Prof Peter Gichangi of the University of Nairobi had then promised to move quickly and carry out a larger trial at the hospital. But even as the announcement was being made, there were signs all was not well for Kenya over ownership of the invention.
Information published in the UK media had indicated the ownership and patent had been applied for solely by the University of Manchester, and the UK couple.
Things became clear when, while responding to inquiries from The Standard, the University of Manchester said Kenya had no claim to the invention.
The invention had been claimed by the British couple, the patent by the University of Manchester, and manufacturing rights by a New Zealand firm.
“Kenyans have no ownership claim in any of this. They did not invent anything, do not co-own the patent while future research and manufacture is the business of the NZ pharmaceutical company,” said Dr Rich Ferrie, of the University of Manchester.
In response, Dr Maranga had vowed to fight for inclusion but there is no evidence KNH or anybody in Kenya ever made any effort to claim ownership. As to the new development, the UK groups had made it clear Kenya was out.
“There is no role envisaged in the specific research agreement for the Kenyan entities which has only two parties to it – The University of Manchester and the New Zealand firm,” said Dr Ferrie.
Ironically, the parties are only able to undertake the proposed human clinical trials because Kenya had allowed its women to act as the ‘guinea pigs’ for an untested treatment.
In earlier reports in the Telegraph of the UK, the clinical trials found their way to KNH because it would have been almost impossible to apply an untested treatment on human subjects in the UK.
Then, Dr Maranga a PhD student at the University of Manchester, working closely with the Hampsons had consequently introduced the project to KNH.
Once diagnosed with early stage cervical cancer, the patients were then put on one capsule of the antiviral drug twice a day for two weeks.
However, the proposed new trials are using a vaginal ointment containing a combination of two regular antiretrovirals – Lopinavir/Ritonavir.
The ointment, the study application says will be self-applied once a day for 21 days in up to three treatment cycles. The proposed trials may forever seal any prospects of Kenya making any claims to the invention.
This means, Kenyan women, like anybody else will have to pay for the treatment when and if it comes to the market.
The Standard Kenya