Once again our apologies for the long delay since our last post. The primary reason has been the ongoing political and military instability in Mali, which has significantly slowed down the coordination of our efforts to make LDN available to the health community in that Country.
As you know, we published two papers in the Journal of AIDS and HIV Research (JAHR) late in 2011that describe the two phases of the Mali Project initiated five years ago. The first paper:
“Single cohort study of the effect of Low Dose Naltrexone on the evolution of immunological, virological and clinical state of HIV+ adults in Mali”
describes the results of giving LDN to a group of 57 HIV positive adults, all of whose CD4 count fell between 350 and 600 cell/mm3 and who showed no symptoms of AIDS. The second paper:
“Impact of Low Dose Naltrexone (LDN) on antiretroviral therapy (ART) treated HIV+ adults in Mali: A single blind randomized clinical trial”
describes the results of comparing the health of two groups of 57 adults each, all of whom were HIV positive, had a CD4 count below 350 cells/mm3 and were receiving standard ARV medications. One group was also given a 3.0 mg dose of LDN and the other a placebo. The purpose of this phase of the study was to see if LDN improved the standard ARV treatment in a significant way.
The complete papers appear in the “LDN Articles” page of this web site. Briefly, in the first study we found that LDN significantly helped HIV positive individuals to maintain their CD4% over a nine-month period. Although the same was not true for the absolute CD4 count, the increase in that measure was less than for a similar population of untreated patients. Since the CD4% is increasingly being seen as a more stable and indicative measure of immune system health, we found these results encouraging.
In the second study involving a population in ARV treatment, LDN improved the CD4 count significantly relative to the control group after six months and marginally after nine months. Although LDN also improved the CD4% over this period of time, those results were not statistically significant. Taken together, the conclusion from the two studies strongly suggests that LDN has a promising role to play in treating HIV/AIDS.
Currently we are preparing to initiate the second cycle of the Mali Project, which includes a large population, possibly multi-country, clinical evaluation of LDN for HIV positive individuals—in other words a “phase III study.” We are considering a variety of subpopulations–including infants, children and adults—as well as comparing the efficacy of LDN in improving the standard ARV treatment, as we did in the first cycle of the Project.
In addition, as planned, we have begun the formal process of bringing LDN into Mali for the treatment of autism, primarily in cream form for infants and children. As we indicated in our previous post, this strategy will take advantage of the world-wide acceptance of LDN in treating autism to familiarize the Mali Health Ministry with its potential in treating that and other autoimmune disorders. Autism is not prevalent in Mali and much less controversial than HIV/AIDS. Familiarizing the Mali medical community with LDN in the context of autism will also direct attention to its use (in dermatological form) with infants and children—which, as you remember, was a major part of the original project vision. Once LDN is available in pharmacies for autism, and the large populations studies are completed, it will be less of a challenge to encourage its use in treating other auto-immune illnesses, including, HIV/AIDS.
When we started the Mali Project six years ago, the interest in LDN was limited to a few practitioners and researchers, mostly working with the treatment of autism and to a lesser extent, Crohn’s Disease. That situation is changing dramatically now, particularly during the past two years. In particular, Transparency Life Sciences (TLS) through its subsidiary, TNI BioTech (TNIB), is in the final phase of setting up an LDN manufacturing plant in Managua, Nicaragua. Here is a summary from a recent exciting TLS press release:
Dr. Nicholas Plotnikoff, Chairman of TNI BioTech, recently announced that his company has acquired all of Dr. Bernard Bihari’s use-patents for low dose naltrexone. This will enable TNIB to proceed with its plans for a phase III clinical trial in both Africa and the US within the next 12 months, as well as plans to manufacture and sell the drug.
TNIB has begun construction of a large pharmaceutical plant in Managua, Nicaragua for the production of LDN, under the trade name of IRT-103. The plant expects to be in operation by the end of 2012 and is to be capable of manufacturing well over one billion of the capsules annually.
Several months ago TNIB contacted us with the aim of finding out more about the Mali Study and involving us in the phase III study they are planning. Since this fit in perfectly with our plans, we have agreed to work with them to create a Pan-African, large scale clinical program that could include as many as four countries. When we first heard about TNIB’s plans, we had some concerns about what would happen to the price of LDN should a large pharmaceutical company take over its manufacturing and distribution. So we were delighted to receive a recent statement from TNIB’s CEO that her company is committed to charging no more than $1.00 a day for LDN,”…because TNIB does not want to undermine LDN’s use as an affordable treatment.”
So in five or six years, LDN has moved from relative obscurity to the frontier of the new medicine in which strengthening the immune system directly plays a central role in the treatment of autoimmune illnesses. Thanks to all of you who have supported our Mali Project. There is still a huge amount of work to do to bring LDN to the millions who can benefit from its capabilities, both as a stand-alone medication and in conjunction with other standard treatment programs. But progress has been made—and the implications for the treatment of HIV/AIDS are unbounded.
We will keep you informed in a more timely way in the future.