National Headquarters
2025 E Street, N.W.
Washington, DC 20006
www.redcross.org
Contact: Lesly Simmons
Phone: (202) 303-4467
Cell: (301) 642-7365
SimmonsL@usa.redcross.org
WASHINGTON, Thursday, September 13, 2007 — Sickle Cell Anemia affects more than 70,000 people in the United States, and most of them are African-American. September is Sickle Cell Anemia Awareness Month, a perfect time to make an appointment to give blood in support of the thousands of people across the country suffering from this disease. One in every 12 African Americans carries the trait for sickle cell disease.
One of the most common treatments for Sickle Cell Anemia, which causes red blood cells to form an abnormal crescent shape, is regular blood transfusions to help reduce the risks of stroke, damage to major organs that can lead to severe infections, and other complications that can arise from the disease. Many patients need blood transfusions every few weeks to help keep the effects of the disease at bay, and transfusions from blood donors of the same ethnic background are even more beneficial because they have less chance of causing complications for the recipient.
“Giving blood is an easy way to help someone in need and feel good about doing it,” said Red Cross National Celebrity Cabinet Member Patti LaBelle. “With so many people in our community suffering from sickle cell anemia, it’s also the right thing to do to help our neighbors and friends in need.”
Additionally, African Americans are more likely to have blood type O and B than other populations. These types are particularly in need, so scheduling a donation can also help alleviate blood shortages around the country.
To schedule an appointment to donate blood, call 1-800-GIVE LIFE, or visit http://www.blogger.com/img/gl.link.gif.
The American Red Cross helps people prevent, prepare for and respond to emergencies. Last year, almost a million volunteers and 35,000 employees helped victims of almost 75,000 disasters; taught lifesaving skills to millions; and helped U.S. service members separated from their families stay connected. Almost 4 million people gave blood through the Red Cross, the largest supplier of blood and blood products in the United States. The American Red Cross is part of the International Red Cross and Red Crescent Movement. An average of 91 cents of every dollar the Red Cross spends is invested in humanitarian services and programs. The Red Cross is not a government agency; it relies on donations of time, money, and blood to do its work.
Thursday, September 13, 2007
Give the Gift of Life During Sickle Cell Anemia Awareness Month
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2 comments:
NICOSAN for the Treatment of Sickle Cell Disease
There is a relatively new treatment for sickle cell being
produced in Nigeria by an American company called NICOSAN®,
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
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 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 or you may have.
NicosanForSickleCell@yahoo.com
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
NICOSAN / NIPRISAN
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