Nicosan

Nicosan (Hemoxin in US), previously Niprisan or Nix-0699, is a phytochemical (ethanol/water extract of Piper guineenses seeds, Pterocapus osum stem, Eugenia caryophyllum fruit, and Sorghum bicolor leaves) being tested for the treatment of Sickle-cell disease (SCD).

Development history
It was developed at the Nigerian National Institute for Pharmaceutical Research and Development (NIPRD) (U.S. Patent # 5,800,819 - September 1, 1998). NIPRD has already conducted Phase I, Phase IIa and IIb clinical trials and is currently conducting Phase III clinical trials in Nigeria.

In August 2002, Xechem International (XKEM/OTC:BB), a New Jersey company, acquired the exclusive world-wide rights to Niprisan (later re-named Nicosan/Hemoxin). On July 6, 2006 the drug was officially launched in Nigeria, with the President of Nigeria, Olusegun Obasanjo, personally in attendance.

The drug has begun with limited production, although it is expected that production will expand to meet demand.

Xechem International is currently in the process of preparing an Investigational New Drug (IND) Application for Nicosan/Hemoxin for submission to the United States Food and Drug Administration (FDA) and applicable EU agencies. Nicosan/Hemoxin has received orphan drug status in the USA and Europe.

Research findings
A Phase IIb trial of Nicosan was conducted at an army base hospital in Yaba, Lagos, Nigeria between 1996 and 1997. Xechem reports that "73% of the 30 patients who participated in the study experienced no crisis during the 12 month trial period and the remaining 27% experienced less frequent and less severe crises."

Main results

Reports of two trials were found, of which only one, including 82 participants, was eligible for inclusion in this review. This Phase IIB (pivotal) trial suggests that a phytomedicine, Nicosan®, was effective in reducing episodes of SCD crisis associated with severe pain over a six-month period. Nicosan® did not appear to affect the risk of severe complications or the level of anaemia. No serious adverse effects were reported.

Authors' conclusions

While Nicosan®, as a phytomedicine, appeared to be safe and effective in reducing crises associated with severe pain over a six-month follow-up period of this trial, further trials are required to assess its role in the management of people with sickle cell disease. The results of Phase III, multicentre trials are awaited. http://www.cochrane.org/reviews/en/ab004448.html

The established drug hydroxyurea acts in SCD as an antisickling agent, however not all patients respond to this drug and some experience adverse effects, including myelosuppression. Nicosan with possibly less adverse effects also appears to work through "a strong antisickling effect".