Herbal-based sickle cell drug shows promise in multi-centre clinical trials

Maurice Iwu is a professor of pharmacognosy and Chief Executive Officer (CEO) of Bioresources Development Group (BDG). Iwu in this interview with The Guardian ahead of the 4th Summit on Clinical Trials held earlier this week in Abuja and the World Sickle Cell Day, June 11, 2016, said that another herbal-based sickle cell drug produced by Neimeth Pharmaceuticals, a subsidiary of BDG, has shown great promise in the management of patients with sickle cell anaemia. The pharmacognocist among other things called for more partnerships in the country towards the development of traditional medicine products. CHUKWUMA MUANYA writes. Excerpts:

June 11 is World Sickle Cell Day. Sickle Cell is one of the most important diseases in Nigeria. How far with the search for herbal cures?
We are still not talking about cure yet because the disease is still far from being well understood. To think that one genetic aberration can cause so much harm and pain to children is still subject of intense study. In our group, we have looked at a lot of drugs but we are concentrating on food substances. We have developed two types of medicines are they are both based on food. One is currently being marketed by Neimeth Pharmaceuticals, but Professor Ekeke from University of Port Harcourt, Rivers State, initiated the work. My group when were at Nsukka looked at it and we found out that it is a very effective product for the treatment of sickle cell disease.

The product is going to be a subject of clinical trial report. Some doctors from University of Lagos, University of Calabar and some other places even the Military Hospital came together. They have done some serious research to prove the clinical efficacy of Ciklavit. The results were presented at the 4th Summit on Clinical Trials held from Monday June 6 to Wednesday June 8, 2016. The other product that was not developed by us but is worthy of mention is the one done by the Nigerian Institute for Pharmaceutical Research and Development (NIPRD) Abuja and also a private company in Lagos called Joblyn and they are all based on the same issue of using sorghum as a base just like Ciklavit that is based on Pigeon pea (Cajanus cajan), which gives you the idea that they are all food based.

What my group has done is that we have just set up a facility at Umuna Okigwe in Imo State. We now want to take it to the next level. We now want to have some foods that children will take and they will not have need for any medication. It is ready to eat therapeutic food that we want to advance.

Is it part of what is call Smart Foods?
Yes they are smart foods in a sense but these ones are specifically going to be for sickle cell?

Can you throw more light on the clinical trials?
There is no need jumping the gun. The people from the universities concerned will do justice to that. This is a research led by a medical doctor who has been a consultant in that area for long.

Is it a cure for sickle cell?
It is a treatment. It is not a cure. You just came back from Kigali where you attended a conference organized by the African Union (AU) on how to improve Traditional Medicine. What were the fallouts?

It was a meeting of experts. We are trying to develop standards, harmonise standards from various countries so that Africa will have a standard. So if want to say Moringa for example, you will say Moringa oleifera is this not that this person has a different terminology. What are the standards that you have to keep? It was a meeting that the Standard Organisation of Nigeria (SON) represented Nigerian interest and the body for the AU is called African Regional Standard Organisation (ARSO). What we did was that Nigeria has proposed some plants which was accepted as plants that they were going to work on to develop standards for. They include Moringa oleifera, Garcinia kola (bitter cola) and eight other plants. These are plants that have been worked on that we have standards for them. Even Vernonia amygdalina (bitter leaf) is part of the plants we have proposed and were accepted by our other colleagues that they are worthy to be studied. We are also putting efforts to adopt other standards other people have developed for example the standard for gum Arabic, which grows a lot in the northern areas of the country. We need to have the standards to be able to make our products to meet international standards.

How about the plans by AU to facilitate the integration of Africa Traditional Medicine into the conventional practice?
It is about standards because without standards even nomenclature you have to standardize it. What do you call African Traditional Medicine (ATM)? What do you mean by phytomedicine? What do you mean by nutraceuticals? So if you develop those standards on ATM you will now be to move forward. The conference was on traditional medicine but how to harmonise standards so that every African country will be able to speak with one voice on what to consider ATM and what it is not. Even the World Health Organisation (WHO) recognizes that our traditional medicine is very unique as different from that of Asia and Latin America.

Another big issue is how to ensure the availability of raw materials for herbal medicine products?
We have farms of our own all over the country; they are about ten hectares. But what is important is that we make sure that we cultivate them in organic manner. We try not to use fertilisers; we try also not to introduce external chemicals into the place. In our farms we do not even use generators we try to use solar. Without cultivation you cannot go far in herbal medicine. But there are some plants that are by nature agroforestry, they take time to grow and that is where you need government to come in because the farmers will not like to commit their money for that because it takes about four to five years to recoup. We also have contract farmers that we engage. But farming without processing doesn’t add any value. That is why we are trying to urge the people concerned to maintain minimum processing that the farm produced can be protected and used when needed.

What are you doing about poor research and development in the herbal medicine industry?
We are about one of the oldest private research institutions in the country. We started in the 1990s. We have sustained viable research programmes in areas that are of interest to us. We are interested in metabolic diseases like diabetes, hypertension and so on. We are also interested generally in cardiovascular diseases. We are interested in the diseases of the ageing processes. Of course we have started a process on highly infectious diseases. We are not talking about ordinary infections but highly infectious diseases. It is a major part of our work. We have also realized that there are two major aspect that we don’t touch; we don’t do primary research, we allow universities that we are collaborating with to do that so that we can have student that are doing preliminary studies and then we pick it up from there; we do more of development.

We also don t do clinical research because we also want clinicians to partner with us. Right now we have sponsored quite some clinical researches in areas that are of interest to us. We are collaborating with Nnamdi Azikiwe University Awka, Anambra State. We are collaborating through Neimeth with some Universities including University of Lagos on clinical trials. While it is also important that we don’t do it ourselves is to remove the issue of bias but if it is academics that are doing the research, they will be balanced and fair.

When you say we, how do you men?
Bioresources Development Group (BDG) is a group of six companies. We have our core laboratory, which is at Nsukka in Enugu State called the International Centre for Ethnomedicine and Drug Development called Intercedd for short. Then we have Bioresources Institute of Nigeria (BIOIN), which is more into raw material research, into a lot of developmental studies and we have model farms under it. We then have Intercedd Health Products (IHP) that is supposed to market those health products developed by Intercedd. We are very specific in the kind of products that they market; they don’t get into pharmaceuticals at all.

We than have Nature’s Emporium. These are unique outlets where only natural products that have satisfied either the National Agency for Food Drug Administration and Control (NAFDAC) and regulatory authorities where they were imported from so that people can have chance to buy wholesome medicinal plants, herbal medicines, dietary supplements and things like that in a particular setting. We have five shops like that in five cities in the country. In a place like Abuja we have about three and about two in Lagos. In this particular concept we allow franchise. People who want to do business in herbal medicine but don’t know how, we will be able to supply them the materials. They become like a distributor but the important thing is that they would be obliged or be restricted to comply with this high ethical standards that we have set in marketing them so that Nigerians will have alternative rather than just all they can do is either they go to Babalawo or they go for foreign medicine.

So those who want to be healthy but want natural-based products will have this middle ground. Then we have Global Biotrade where we have to make sure that Nigerian medicinal plants are traded oversees in a very ethical manner. So example some Nigerian medicinal plants are sought after overseas but because of low standards they don’t fetch premium prices. We work with suppliers who are interested in value enhancement. We don’t take ownership of their material, all we do is to provide them scientific handling of what they do. Some states are buying into this and we help their people.

BIOIN also runs entrepreneurship programme. So when we talk about we it is these institutions collectively. We are also key promoter and shareholder of Neimeth, our pharmaceutical industry. So things that are pharmaceutical in nature like Ciklatvit, we promote through Neimeth. Neimeth is not just a pharmaceutical company; it is an African pharmaceutical company. We want to pride ourselves that we are still the only one we know that makes active pharmaceutical ingredients locally and have them of international standards. It is not just that we are interested in making money; we are also interested to develop that sector.

How about your plan to set up centers across the country?
Yes, we just set up a model processing plant in Imo state, one because we had the land, the facility, we are seeking to have a plot here in Abuja to set up another processing centre. We intend to have them in all the six-geo political zones. The idea here is that if we do not have Good Manufacturing Practice (GMP) level manufacturing facility, you can never really compete with the rest of the world. We want something that if the United States Food and Drug Administration (FDA) comes to inspect, they would say ‘this is good enough or it is not as good but it will pass that the basic laws are followed in term of infrastructure and in terms of the process. So we intend to commence work and we also having another plant purely for pharmaceuticals at Amawbia in Oka in Anambra state.

That one again is because we had a partnership with the former governor and he was generous in giving us the premises. So the areas of the country that are seriously interested in medicinal plant, in adding value to their crops, because it is not only the medicinal plants we use in those facilities, we can also do other things there. We are thinking seriously of setting up a special purpose plant around the southwest to be able to cater to the pharmaceutical companies in Lagos and so on, just to be making pharmaceutical attaches, excipients for manufacturing of drugs. Our Natures’ Emporium, that is the outlet setting of shops all over the country and also asking individuals who are inclined to come forward and negotiate with our Natures’ Emporium people, because we do not want to own the shops ourselves in most cases.