tag:blogger.com,1999:blog-659197563728114440.post5210819856639049346..comments2023-09-15T05:36:24.265-04:00Comments on Marijke: Nurse Turned Writer: Sickle Cell AnemiaMarijke Vroomen-Durninghttp://www.blogger.com/profile/14436563110710429784noreply@blogger.comBlogger3125tag:blogger.com,1999:blog-659197563728114440.post-64333853607047409692008-06-13T16:55:00.000-04:002008-06-13T16:55:00.000-04:00excellent drugexcellent drugAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-659197563728114440.post-70903864712462723472008-03-05T23:39:00.000-05:002008-03-05T23:39:00.000-05:00United Nations Economic Commission For AfricaBook ...United Nations Economic Commission For Africa<BR/><BR/>Book Of Abstracts <BR/><BR/>Science With Africa Conference<BR/><BR/>March 3-7, 2008<BR/><BR/>page 30<BR/><BR/><BR/><BR/>Evaluation of Niprisan (Herbal Medicine) for the Management of Sickle Cell <BR/>Anaemia <BR/> <BR/>Charles Wambebe and Hadiza Khamofu, International Biomedical Research in Africa, Abuja, <BR/>Nigeria, wambebe@yahoo.com, Joseph Okogun, Nathan Nasipuri and Karynius Gamaniel, <BR/>National Institute for Pharmaceutical Research and Development, Abuja, Nigeria. <BR/> <BR/> <BR/>About 70% of all sickle cell anemia (SCA) subjects reside in Africa, estimated at over 12 million. The prevalence of SCA is estimated at over 2% while infant mortality is about 8% and survival rate of SCA babies in rural areas by five years of age is about 20%. These statistics indicate that SCA is probably the most neglected (and sometimes forgotten by health authorities) serious public health disorder with serious mortality and morbidity rates in Africa. The objective was to undertake pre-clinical and clinical assessments of a herbal extract vis-à-vis management of sickle cell anemia using Good Laboratory Practice and Good Clinical Practice principles respectively. In Africa, there is no standard treatment for sickle cell anemia, only palliative management is generally available. In view of this situation, most SCA subjects use herbal medicines. NIPRISAN is a standardized extract from four medicinal/food plants: Piper guineenses seeds, Pterocarpus osun stem, Eugenia caryophyllum fruit and Sorghum bicolor leaves. Short term toxicity study indicated that NIPRISAN was safe in laboratory animals. Bio-activity guided fractionation show that vanillin and aromatic aldehydes may be the bioactive moieties. NIPRISAN reversed sickled red blood cells and <BR/>protected them from being sickled when exposed to low oxygen tension. NIPRISAN dose-dependently delayed polymer formation of haemoglobin S. NIPRISAN induced 85% increased solubility of deoxy haemoglobin S. The in vivo efficacy study was undertaken at Children Hospital of Philadelphia, USA. Histological examination of lungs of control Tg transgenic mice carrying human sickle haemoglobin showed entrapment of massive numbers of sickled cells in alveolar capillaries. NIPRISAN significantly cleared the lungs of sickled cells. Furthermore, NIPRISAN induced profound effect on the survival time of Tg mice under hypoxic conditions (p<0.0001). The phase II clinical data indicated that all the subjects benefited from NIPRISAN with no serious adverse effect. About 80% of the subjects did not experience any crisis during the study (12 months). The subjects experienced significant reduction in hospital admission while attendance at school profoundly increased. Furthermore, there was no evidence of kidney or liver damage. NIPRISAN has been patented, licensed to an American company, registered and being manufactured at Abuja for global market. <BR/> <BR/>http://www.uneca.org/sciencewithafrica/content/swa_book_of_abstacts-en.pdf<BR/><BR/><BR/>NICOSAN / NIPRISANAsclepiushttps://www.blogger.com/profile/11618703917815137740noreply@blogger.comtag:blogger.com,1999:blog-659197563728114440.post-63250639194573901512008-02-17T12:44:00.000-05:002008-02-17T12:44:00.000-05:00NICOSAN for the Treatment of Sickle Cell DiseaseTh...NICOSAN for the Treatment of Sickle Cell Disease<BR/><BR/><BR/><BR/>There is a relatively new treatment for sickle cell being<BR/>produced in Nigeria by an American company called NICOSAN®,<BR/>it's proprietary name is NIPRISAN® . It was developed on<BR/>the premise of traditional Nigerian plant based medicinal<BR/>practices for the treatment of sickle cell disease.<BR/><BR/>It has been tested through phase IIb clinical trials and<BR/>found to be highly efficacious. Phase III trials have yet<BR/>to be completed however it was approved for sale in Nigeria<BR/>based on phase IIb trials and toxicity studies which showed<BR/>it to be safe and non-toxic. <BR/><BR/>Double-blind, placebo-controlled, randomised cross-over<BR/>clinical trial of NIPRISAN® in patients with Sickle Cell<BR/>Disorder<BR/><BR/>http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B7GVW-4DS346T-1S&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=211981d545303693affebb8c012d2cac<BR/><BR/><BR/><BR/>Efficacy of Niprisan in the prophylactic management of<BR/>patients with sickle cell disease<BR/><BR/>http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6VS8-43DFJCH-G&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=10528ecbab3ec7e977301fb9f2688ef6<BR/><BR/><BR/><BR/>NIPRISAN -- Nix-0699 Toxicity Studies<BR/><BR/>http://www.biospace.com/news_story.aspx?StoryID=15890720&full=1<BR/><BR/><BR/>Niprisan (Nix-0699) improves the survival rates of<BR/>transgenic sickle cell mice under acute severe hypoxic<BR/>conditions<BR/><BR/>http://www.blackwell-synergy.com/doi/abs/10.1046/j.1365-2141.2003.04536.x?journalCode=bjh<BR/><BR/><BR/>NIPRISAN Case, Nigeria <BR/>A Report for GenBenefit (2007) <BR/><BR/>http://www.theparliament.com/NR/rdonlyres/F46A1A12-0A1A-41DA-9F5D-A11486CA9BFA/0/Nigerian_Case.pdf<BR/><BR/><BR/><BR/><BR/>This drug is a major advancement in the treatment of sickle<BR/>cell disease unfortunately it is not available in the U.S..<BR/>Although the compound has been granted orphan drug status<BR/>by the FDA and the regulatory body of the European Union,<BR/>to date investigational drug applications for the approval<BR/>process have yet to be submitted. Getting a drug approved<BR/>in either area is extremely expensive. Until there is<BR/>funding available to proceed with the FDA and EU<BR/>applications it will be difficult for non-Nigerians to<BR/>obtain the drug.<BR/><BR/>I do say difficult but it is not impossible. If you have a<BR/>hematologist or hemoncologist who is willing to put fourth<BR/>the effort there are special dispensations available<BR/>through the FDA for the importation of unapproved drugs on<BR/>a compassionate use basis. <BR/><BR/><BR/><BR/>"Expanded access program (EAP). EAPs are typically designed<BR/>to provide widespread access to a drug that has proven<BR/>efficacy in clinical trials but is still awaiting FDA<BR/>approval. They’re similar to standard clinical trials with<BR/>a specific treatment plan and certain FDA requirements, but<BR/>they have looser patient eligibility criteria. More than<BR/>23,000 U.S. cancer patients enrolled in an EAP for Iressa<BR/>before it was FDA-approved, for example."<BR/><BR/>"Single patient use. This program offers an experimental<BR/>drug to an individual patient, rather than a group. The FDA<BR/>approves these uses on a case-by-case basis. Decisions are<BR/>based on other treatments already available and information<BR/>about the drug’s efficacy and potential toxicities."<BR/><BR/>http://www.curetoday.com/backissues/v3n3/departments/specialreport/index.html<BR/><BR/><BR/><BR/>To date I have no knowledge that anyone has sought any<BR/>single use or expanded access from the FDA for Nicosan.<BR/>Unfortunately regardless of the dissemination of this<BR/>information thus far no one has put forth the effort to<BR/>obtain the drug for use. <BR/><BR/>If just one person would start the ball rolling with a<BR/>caring and concerned medical practitioner it could open up<BR/>the drug for wide spread use by tens of thousands of<BR/>patients across the U.S. Unfortunately thus far the general<BR/>response I receive is that people don't believe that their<BR/>physician would be interested in going to this sort of<BR/>effort nor do they themselves seem to be inclined to seek<BR/>the use of a treatment that could potentially end their<BR/>crises. <BR/><BR/>There has to be at least one physician out there who has<BR/>enough care and concern for his patients to be willing to<BR/>put forth the effort necessary to obtain this medication<BR/>legally. I urge anyone who is effected by sickle cell to<BR/>approach their physicians with this information and attempt<BR/>to obtain this treatment not only for themselves but for<BR/>all patients who could potentially benefit from it's use. <BR/><BR/>We already know the benefits of the treatments available in<BR/>the U.S. and the E.U.. In many cases they are only<BR/>marginally effective or in the case of hydroxyurea cause<BR/>side effects so serious that many choose not to use it as<BR/>treatment. Here we have an opportunity to use a treatment<BR/>that has been shown to be highly effective, eradicating<BR/>crises in the majority of patients and reducing crises by<BR/>50% in the most refractory cases.<BR/><BR/>Although the clinical trial group was what the casual<BR/>reader might interpret as quite small it is common for<BR/>drugs which fall into the orphan drug category to use small<BR/>sample groups. Many orphan drugs have been approved based<BR/>on very small phase II and phase IIb clinical trials in the<BR/>U.S. In the case of FDA fast track status, a drug may be<BR/>approved during phase II trials if the drug shows<BR/>significant advantage over current approved therapies for<BR/>life threatening illness. <BR/><BR/>Fast Track Designation is a program that, if granted, is<BR/>designed to facilitate the development and expedite the<BR/>review of new drugs, thereby allowing the FDA to approve<BR/>drugs used to treat a serious condition or a<BR/>life-threatening disease with less safety data following<BR/>the conclusion of phase II studies, rather than phase III,<BR/>the normal practice.<BR/><BR/>The main criterion for a Fast Track Designated drug is the<BR/>potential to treat a life-threatening illness or fill a<BR/>major unmet medical need. Fast Track may be submitted with<BR/>the IND or at any time during the clinical development of<BR/>the drug. The Fast Track designation may allow a company's<BR/>application to follow Priority Review, Standard Review, or<BR/>a Rolling Review of the application.<BR/><BR/>http://www.fda.gov/CbER/gdlns/fsttrk.pdf<BR/><BR/><BR/><BR/>Nicosan by Western standards is an extremely inexpensive<BR/>drug. It is available in Nigeria without prescription at<BR/>$23/month for adults and child doses at $18/month. <BR/><BR/>Here is a link to the company and product website. <BR/><BR/>http://xechemnigeria.com/products.htm<BR/><BR/><BR/>I sincerely hope that you find this information helpful. I<BR/>would encourage you to to forward and post this information<BR/>to any person, blog or website where persons effected by<BR/>sickle cell anemia can have access to this information.<BR/><BR/>Feel free to write me with any questions or you may have.<BR/><BR/>NicosanForSickleCell@yahoo.comAsclepiushttps://www.blogger.com/profile/11618703917815137740noreply@blogger.com