… Promising therapies now in limbo
Research has been the bedrock of several scientific discoveries and breakthroughs across the globe. With researchers having to contend with the challenge of developing drugs to combat certain ailments, efforts at developing a potential therapy for sickle cell diseases and other ailments by the National Institute for Pharmaceutical Research and Development (NIPRD), Abuja seems to have hit the rock.
This is following recent reports which suggest that the institute, which develops traditional herbal remedies into drug candidates failed to secure the funding it expected this year and this has grounded research at the institute. Following this development, scientists are urging the Nigerian government to provide the financial support needed to save research programmes at the institute.
The institute has already developed a potential therapy for sickle-cell disease (SCD) and has encouraging results for compounds to treat malaria and tuberculosis. Sadly, a key grant from the United States National Institute of Allergy and Infectious Diseases (NIAID) has run out and the Federal Ministry of Health has failed to deliver an expected increase to its contribution. As a result of this, research on all three drugs has come to a standstill.
According to Karniyus Gamaniel, director general, NIPRD, the N49 million (US$325,000) NIPRD institute received this year from the Ministry of Health is not enough to cover the institute’s annual running costs of 265 million naira.
Gamaniel noted that the institute also received N70 million from the ministry in 2010 for capital projects, but lamented that this falls short of the more than US$2 million needed to buy equipment and for other infrastructural projects.
“There are lots of things we don’t do because we have no money. For instance, the institute needs N50 million in addition to its running costs to mount an 800-patient phase III clinical trial on its anti-malaria drug. In addition, one of the institute’s flagship laboratories, set up in 2005 with a grant of US$25 million from the National Institute of Allergy and Infectious Diseases (NIAID), is lying idle. NIPRD needs about N23million a year to cover maintenance costs and ensure a constant supply of electricity,” Gamaniel disclosed.
Joseph Okogun, a consultant phytochemist for NIPRD, said: “Without funding for this lab, it cannot carry out essential analyses of the structures of chemical compounds in their tuberculosis drug candidate, which is a mix of herbal extracts that have been shown to slow the growth of the tuberculosis bacterium. If funded, maybe, in six to 10 years time, we might get something developed into a drug.”
No doubt, the effects of the funding problems on efforts to test Nicosan (Niprisan) might jeopardise the institute’s potential treatment for sickle-cell anaemia — a genetic disease said to be associated with complications and a reduced life expectancy in people affected with the disease.
Patients with the disease have ‘sickle’-shaped red blood cells, which can clump together to block blood vessels, thereby causing strokes or pain. Based on West African plant extracts, Nicosan appeared to slow the clumping of blood cells in lab tests and early trials of the drug in patients suggested that it relieved some of the painful symptoms of the disease.
The Phase IIB (pivotal) trial suggests that Niprisan was effective in reducing episodes of severe painful SCD crisis over a six-month period. It did not affect the risk of severe complications or the level of anaemia. No serious adverse effects were reported. The single trial of Cajanus cajan (Ciklavit) reported a possible benefit to individuals with painful crises, and a possible adverse effect (non-significant) on the level of anaemia.
Furthermore, Nicosan was being produced in the country by the Nigerian subsidiary of US chemical company Xechem International. Just last year, Xechem International closed its factory and despite promises by the Nigerian government that it would restart production, the drug is currently unavailable.
Although the results of phase III clinical trials with Nicosan, funded by NIPRD, are yet to be published, Gamaniel admitted that they were “inconclusive.” In addition, financial constraints have hindered NIPRD from doing more phase III trials of the drug.
Taking a cursory look at the treatment of sickle cell disease, the sickle-cell drug hydroxyurea was marketed nearly two decades ago. However, the list of drugs able to treat the symptoms of the disease has been “abysmally short to nonexistent.”
Though no conclusions can be made regarding the efficacy of Ciklavit currently, based on the published results for Niprisan and in view of the limitations in data collection and analysis of both trials, phytomedicines (medicine derived from plants in their original state) may have a potential beneficial effect in reducing painful crises in SCD. This needs to be further validated in future trials to ascertain the safety and efficacy of phytomedicines in managing SCD.
No doubt, the NIPRD and other research institutes in the country are in a position to develop products or processes which can compete with imported technologies that are saturating the economy if well funded. Furthermore, efforts should be made by the institute, including other research institutes in the country, to draft a proposal for funding to the World Bank, the Global Fund to fight AIDS, tuberculosis and malaria, and other philanthropic organisations for grants. In this way, much of the funding can be used to upgrade the institute’s laboratories so that they can push forward the work on their drug candidates.
By alexander Chiejina
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