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Romance / Re: My Girlfriend And I Are Both AS by Asclepius: 9:32pm On Apr 25, 2008 |
United Nations Economic Commission For Africa Book Of Abstracts Science With Africa Conference March 3-7, 2008 page 30 Evaluation of Niprisan (Herbal Medicine) for the Management of Sickle Cell Anaemia Charles Wambebe and Hadiza Khamofu, International Biomedical Research in Africa, Abuja, Nigeria, wambebe@yahoo.com, Joseph Okogun, Nathan Nasipuri and Karynius Gamaniel, National Institute for Pharmaceutical Research and Development, Abuja, Nigeria. 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 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. http://www.uneca.org/sciencewithafrica/content/swa_book_of_abstacts-en.pdf |
Romance / Re: My Girlfriend And I Are Both AS by Asclepius: 9:32pm On Apr 25, 2008 |
Do many people in Nigeria know about Nicosan? It's a shame that a drug developed by NIPRD doesn't seem to be getting any government support. The least they could do would be to promote some educational campaign so that people are aware of it's existence. In clinical trials 80% of patients who took the drug experienced no crises and the other 20% their crises were reduced by half. In the U.S. we're anxious for this drug to be approved for use here! NICOSAN, FDA Orphan Drug for the Treatment of Sickle Cell Disease I would like to make you aware that there is a non-toxic viable treatment for sickle cell in the world and awaiting application for approval in the U.S. and E.U. In clinical trials 80% of patients had no crises and in the refractory 20% crises were reduced by half. Through awareness there may come availability for those who so desperately need it. All it is going to take is the effort of a few individuals, patients and doctors to make this drug a reality in the U.S. sooner than later. Although this drug was developed in Nigeria, the man behind it, Dr. Ramesh Pandey is a distinguished biochemist who has worked for the National Cancer Institute's (NCI) Frederick Cancer Research Center as a Senior Scientist, Head of the Chemistry Section, Abbott Pharmaceuticals and produced the first commercially viable generic version of Vancomycin for Lyphomed Inc., a Visiting Professor at the Waksman Institute of Microbiology at Rutgers, the State University of New Jersey, holds patents for biotechnology analysis and rare drug production processes. He also holds several US and international patents for paclitaxel and its new analogs. He is a member of the Editorial Board of the International Journal of Antibiotics and of several professional societies. He has been awarded several grants from NASA, NCI and NIH. The drug NICOSAN has been granted Orphan Drug Status by both the FDA and E.U, This new treatment for sickle cell is being produced in Nigeria by an American pharmaceutical company, trade name NICOSAN®, and it's proprietary name is NIPRISAN® . It was developed on the premise of traditional Nigerian plant based medicinal practices for the treatment of sickle cell disease. It has been tested through phase IIb clinical trials and found to be highly efficacious. Phase III trials have yet to be completed however it was approved for sale in Nigeria based on phase IIb trials and toxicity studies which showed it to be safe and non-toxic. Double-blind, placebo-controlled, randomised cross-over clinical trial of NIPRISAN® in patients with Sickle Cell Disorder 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 Efficacy of Niprisan in the prophylactic management of patients with sickle cell disease 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 NIPRISAN -- Nix-0699 Toxicity Studies http://www.biospace.com/news_story.aspx?StoryID=15890720&full=1 Niprisan (Nix-0699) improves the survival rates of transgenic sickle cell mice under acute severe hypoxic conditions http://www.blackwell-synergy.com/doi/abs/10.1046/j.1365-2141.2003.04536.x?journalCode=bjh THE DEVELOPMENT OF NICOSANTM/HEMOXINTM A DRUG FOR THE MANAGEMENT OF SICKLE CELL DISEASE. HISTORICAL BACKGROUND http://shestco.net/5_tech_park/nicosan.pdf NIPRISAN Case, Nigeria A Report for GenBenefit (2007) http://www.theparliament.com/NR/rdonlyres/F46A1A12-0A1A-41DA-9F5D-A11486CA9BFA/0/Nigerian_Case.pdf This drug is a major advancement in the treatment of sickle cell disease unfortunately it is not available in the U.S, Although the compound has been granted orphan drug status by the FDA and the regulatory body of the European Union, to date investigational drug applications for the approval process have yet to be submitted. Getting a drug approved in either area is extremely expensive. Until there is funding available to proceed with the FDA and EU applications it will be difficult for non-Nigerians to obtain the drug. I do say difficult but it is not impossible. If you have a hematologist or hemoncologist who is willing to put fourth the effort there are special dispensations available through the FDA for the importation of unapproved drugs on a compassionate use basis. "Expanded access program (EAP). EAPs are typically designed to provide widespread access to a drug that has proven efficacy in clinical trials but is still awaiting FDA approval. They’re similar to standard clinical trials with a specific treatment plan and certain FDA requirements, but they have looser patient eligibility criteria. More than 23,000 U.S. cancer patients enrolled in an EAP for Iressa before it was FDA-approved, for example." "Single patient use. This program offers an experimental drug to an individual patient, rather than a group. The FDA approves these uses on a case-by-case basis. Decisions are based on other treatments already available and information about the drug’s efficacy and potential toxicities." http://www.curetoday.com/backissues/v3n3/departments/specialreport/index.html To date I have no knowledge that anyone has sought any single use or expanded access from the FDA for Nicosan. Unfortunately regardless of the dissemination of this information thus far no one has put forth the effort to obtain the drug for use. If just one person would start the ball rolling with a caring and concerned medical practitioner it could open up the drug for wide spread use by tens of thousands of patients across the U.S. Unfortunately thus far the general response I receive is that people don't believe that their physician would be interested in going to this sort of effort nor do they themselves seem to be inclined to seek the use of a treatment that could potentially end their crises. There has to be at least one physician out there who has enough care and concern for his patients to be willing to put forth the effort necessary to obtain this medication legally. I urge anyone who is effected by sickle cell to approach their physicians with this information and attempt to obtain this treatment not only for themselves but for all patients who could potentially benefit from it's use. We already know the benefits of the treatments available in the U.S. and the E.U, In many cases they are only marginally effective or in the case of hydroxyurea cause side effects so serious that many choose not to use it as treatment. Here we have an opportunity to use a treatment that has been shown to be highly effective, eradicating crises in the majority of patients and reducing crises by 50% in the most refractory cases. Although the clinical trial group was what the casual reader might interpret as quite small it is common for drugs which fall into the orphan drug category to use small sample groups. Many orphan drugs have been approved based on very small phase II and phase IIb clinical trials in the U.S. In the case of FDA fast track status, a drug may be approved during phase II trials if the drug shows significant advantage over current approved therapies for life threatening illness. Fast Track Designation is a program that, if granted, is designed to facilitate the development and expedite the review of new drugs, thereby allowing the FDA to approve drugs used to treat a serious condition or a life-threatening disease with less safety data following the conclusion of phase II studies, rather than phase III, the normal practice. The main criterion for a Fast Track Designated drug is the potential to treat a life-threatening illness or fill a major unmet medical need. Fast Track may be submitted with the IND or at any time during the clinical development of the drug. The Fast Track designation may allow a company's application to follow Priority Review, Standard Review, or a Rolling Review of the application. http://www.fda.gov/CbER/gdlns/fsttrk.pdf Nicosan by Western standards is an extremely inexpensive drug. It is available in Nigeria without prescription at $23/month for adults and child doses at $18/month. Here is a link to the company and product website. http://xechemnigeria.com/products.htm I sincerely hope that you find this information helpful. I would encourage you to forward and post this information to any person, blog or website where persons effected by sickle cell anemia can have access to this information. Feel free to write me with any questions you may have. Kristina Bruce RN NicosanForSickleCell@yahoo.com |
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