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Excellent point! It works both ways for loyalty to one another. IMO, when Xechem prospers, infusion of more investment dollars by the new and existing shareholders will sustain the exponential growth of the company. Investors' confidence soars with the reward of loyalty to the shareholders.
I believe we'll be there!
Many thanks to Monty!
YES! GO, CSO, GO!!!
WOW!!!
What a mighty good looking tree house! Thanks for your generosity!
Yes! Stand tall but watch your back, Monty!
Nothing compares to the personal disclosure of what you know...much like the way The Good Lord got His message across. So, I see that you've been walking those extra miles, literally!
God Speed, Monty!!!
Hi Raven,
I think you need a clone to help you out! Hard to believe that you can work so much at home and at work and still keep on top of things for Xechem.
Have a great day!
Good Morning All!
Perhaps someday soon we'll look back and realize those "9" and "1" are soooooooooooooooo DIRT CHEAP!!!
All the best to all the LONGS!
IMHO, you've passed the interview brilliantly, LOL! I am sure you already got the unamimous vote of confidence from all the shareholders! Just write your own ticket to get started whenever you see fit!
GO Monty GO!!! GO Monty GO!!! GO Monty GO!!!
Take care!
Light-heartedness = less stress... next best thing than soaking up the sun on the white sand beach of Aruba!?!?
Normally, a company like this would have its products distributed to the moon already, if there is SCD there. Unfortunately...
It takes good leadership with vision along with a dedicated BOD to realize the real potential of this company.
Whatever it is, don't you ever consider the word "OVERSIGHT"...
It stings!!!
In a nut shell, he is a God-send... a figure larger than life!
He is a workaholic of some sort, always stays in focus, in spite of dealing with seemingly endless challenges and frustration. He works relentlessly.
Without him, XeChem would have been long gone...
Without him, long-term shareholders like me and others would have lost faith in this company that could be so important for millions of Sickle Cell Anemia sufferers...
Without him, I could kiss good-bye to all my shares bought for the past several years at much higher prices...
No words can describe how grateful we are to a person of such integrity. We're looking forward to receiving his leadership to turn around XeChem and head for a bright future.
Yup! CSO is good for now. Quite appropriately, sweeping the dirty old BOD out and start a new BOD clean slate!!! You can wait a little for your CEO title, can't you? LOL!
You're very welcome, LOCHUTE!
Monty,
We're expecting your greetings from Aruba...knowing that you have a habit of "Forget-us-not"!
I would SECOND to that motion.
Belated Happy Anniversary, LOCHUTE!
We're with you all the way, Monty, with our ultimate ammunition: voting power to elect a new Board!
Go, new Board, go!!!
AMEN!!!
I admire your stamina to stay focus! I am sure it hasn't been easy.
Congratulations, Monty! Let your true grit of a good leader shine!
IMO,loyal long term holders will tip the critical balance eventually when the time comes to exercise our voting power. I'd rather see the voting power remains in the hands of the loyalists.
Hang in there, long terms! Your patience will be nicely rewarded.
All the best to you!
me four
Many thanks again, Monty, for staying on top of everything! No words can explain how grateful we are as shareholders. Let's hope that pharmaceutical grade Nicosan will soon be back in full scale production for good.
Good thought!
Dear Longterm42,
All the best to you and your company!
Regards,
Last time I heard from him was April 16. He was in the middle of a number of things, most importantly trying to work out deals with three different groups. That is all the extent of public disclosure that I want to make.
He'll be in touch soon!
Have a nice day!
Big pharma's mission is to make sure that herbal drugs do not erode their market share of colossal revenues. Any successful launching of herbal drugs is a potential threat to the big pharmas. RS would be a great candidate to work for any major pharmas with clandestine backing!
Morning all!
As far as I know, Monty has been extremely busy doing a lot of work behind the scene. He will give us an update as soon as he can.
Have a nice day!
I expect that all the detail evidence will be presented by our lawyer and Monty's team to the SEC, the judge and all the pertinent authorities.
Thank you.
It's the least that I can contribute...
AN OPEN LETTER TO PRESIDENT BARACK OBAMA
Carbon copy to:
http://investorshub.advfn.com/boards/getboards.asp?SearchStr=xkemqCC. 2iiINVESTORShUB.estorsHub.Com, Inc.
April 15, 2009
Dear President Obama,
I don’t know if this letter will ever get to you in time since you have been such a busy President with a lot of important agenda to attend to. As this letter will be an open-letter published in the InvestorsHub website to communicate with all the shareholders and those interested in knowing about this company called Xechem Inc. (Ticker Symbol: Listed on Pinksheets = XKEMQ), one of the subsidiaries of XeChem International, Inc., I thought you should be aware of this open-letter as a “carbon copy”. In a nutshell, XeChem is on the verge of becoming bankrupt. I thought that as a long term supporter and shareholder of this company, I owe it to myself and this company that I have been supporting to plead with you for your help. Your help, if granted, is going to be for a very good cause to save millions of lives and millions of patients suffering from a disease called Sickle Cell Disease. This disease costs even more in terms of hospitalization and treatments that are so far quite ineffective and with much undesirable side-effects. Sickle Cell Disease is a disease that affects millions of people worldwide. In the United States alone, the disease affects about 70,000 people-mainly African Americans.
I would like to draw your attention to this very important humanitarian matter. Being a long term shareholder of XeChem, I would like to speak on behalf of all the shareholders who have been supporting this company for many years emotionally and financially, from its early research stage to presently at a stage that it has the credential and ability to mass produce Nicosan in the Nigerian subsidiary to become an important drug manufacturer. This could be a classic success story for many years to tell. It could be a major triumph of humanitarian success that crosses international borders in our global village to help millions of Africans as well as African-Americans. The existence of XeChem is currently at a very critical stage. Our hope is to save this company from going under and to give the shareholders some decent return on their investment. Ever since this company was taken over by Dr. Robert Swift, a lot of alleged abuse of funds and lack of compliance with the SEC have been documented. We need your help to make sure that the SEC is going to have a thorough investigation of all the evidences presented against Dr. Robert Swift, the CEO, and his collaborators. With your help and the investigation by the SEC, the judge can make an informed decision to resurrect XeChem. The creditors will likely grant us a second chance. As a result, there will be a good chance that XeChem can turn around and have a successful restructure under a new and competent board likely spear-headed by Mr. Monty Forthun who has been working relentlessly trying to turn this company around. If financial assistance in the amount of two to three million dollars can be given to XeChem as a grant, that will be vital --- bless your heart! However, a loan of the same amount to XeChem will help tremendously also. Unlike any other bail-outs, XeChem will be in a good position to pay back the loan in full in a relatively short period of time due to its ability to sell this highly demanded drug (Nicosan) that has been sold and manufactured successfully with proven track record in XeChem’s Nigerian subsidiary, XeChem Nigeria. For your information, Nicosan, a drug derived from herbal extracts indigenous to Nigeria, has been granted an Orphan Drug Status by the FDA, and has been proven to be very effective and non-toxic to treat this disease. More over, Dr. Ramesh Pandey, the founding scientist who has been working tirelessly to bring it from the research to the manufacturing level, will once again be able to oversee the scientific production and development of this life-saving drug and its affiliated medicines. For any inquiries, you may contact Mr. Monty Forthun* as noted in the post-script. For your further information please see the detail as following. Currently, the production of Nicosan has been halted due to insufficient management and funding. There are numerous corrupt allegations that we shareholders would like the SEC to look into to safeguard the interest of the shareholders as well as the survival of XeChem. If financial help is unavailable, at the least please help to ensure that SEC is doing their very best job possible in this regard. Your kind word to encourage the Nigerian Government to work with our new Board of Directors to turn around XeChem, Inc. will be greatly appreciated also.
• Xechem International, Inc. (PINKSHEETS: XKEM) (the "Company" or "Xechem") announced today, November 10, 2008, that it and one of its subsidiaries, Xechem, Inc., filed voluntary petitions for relief under Chapter 11 of the United States Bankruptcy Code in the United States Bankruptcy Court for the Northern District of Illinois (the "Bankruptcy Court") to suspend all litigation and to restructure its debt. The Company intends to work with all of its constituencies to reach mutually acceptable resolutions and to exit bankruptcy as expeditiously as possible. Xechem's operations are expected to continue as normal throughout the bankruptcy process, while the Company executes on its reorganization plans. Xechem's other subsidiaries are not part of this Chapter 11 filing. Xechem's Nigerian subsidiary, Xechem Pharmaceuticals Nigeria Limited, will continue its normal operations of the manufacturing and sale of NICOSAN(TM), a drug approved for marketing in Nigeria for the management of Sickle Cell Disease.
Regarding Sickle Cell Disease:
• Sickle cell anemia is a serious disease in which the body makes sickle-shaped red blood cells. "Sickle-shaped" means that the red blood cells are shaped like a "C."
• Normal red blood cells are disc-shaped and move easily through your blood vessels. Red blood cells contain the protein hemoglobin. This iron-rich protein gives blood its red color and carries oxygen from the lungs to the rest of the body.
• Sickle cells contain abnormal hemoglobin that causes the cells to have a sickle shape. Sickle-shaped cells don't move easily through your blood vessels. They're stiff and sticky and tend to form clumps and get stuck in the blood vessels.
• The clumps of sickle cells block blood flow in the blood vessels that lead to the limbs and organs. Blocked blood vessels can cause pain, serious infections, and organ damage.
• Sickle cell anemia is an inherited, lifelong disease. People who have sickle cell anemia are born with it. They inherit two copies of the sickle cell gene-one from each parent.
• People who inherit only one sickle cell gene (from one parent) have a condition called sickle cell trait. Sickle cell trait is different from sickle cell anemia. People who have the condition usually have no signs or symptoms and lead normal lives. However, they can pass the sickle cell gene to their children.
• Sickle cell anemia affects millions of people worldwide. In the United States, the disease affects about 70,000 people-mainly African Americans.
• The most common signs and symptoms of sickle cell anemia are linked to anemia and pain. Sudden pain throughout the body is a common symptom of sickle cell anemia. This pain is called a "sickle cell crisis." Sickle cell crises often affect the bones, lungs, abdomen, and joints.
Signs and Symptoms Related to Pain
Sudden pain throughout the body is a common symptom of sickle cell anemia. This pain is called a "sickle cell crisis." Sickle cell crises often affect the bones, lungs, abdomen, and joints.
A sickle cell crisis occurs when sickled red blood cells form clumps in the bloodstream. (Other cells also may play a role in this clumping process.) These clumps of cells block blood flow through the small blood vessels in the limbs and organs. This can cause pain and organ damage.
The pain from sickle cell crises can be acute or chronic, but acute pain is more common. Acute pain is sudden from hours to a few days. Chronic pain often lasts for weeks to months. Chronic pain can be hard to bear and mentally draining. This pain may severely limit your daily activities.
Almost all people who have sickle cell anemia have painful crises at some point in their lives. Some have these crises less than once a year. Others may have 15 or more crises in a year.
The effects of sickle cell crises on different parts of the body can cause a number of complications.
Many factors can play a role in a sickle cell crisis. Often, more than one factor is involved and the exact cause isn't known. You can control some factors. For example, your risk for a sickle cell crisis increases if you're dehydrated (your body doesn't have enough fluid). Drinking plenty of fluids can lower your risk for a painful crisis. Other factors, such as an infection, you can't control.
Painful crises are the leading cause of emergency room visits and hospitalizations of people who have sickle cell anemia.
Complications of Sickle Cell Anemia
The effects of sickle cell crises on different parts of the body can cause a number of complications.
Hand-Foot Syndrome
Sickle cells can block the small blood vessels in the hands or feet. This condition is called hand-foot syndrome. It can lead to pain, swelling, and fever. One or both hands and/or feet may be affected at the same time.
You may feel the pain in the many bones of the hands and feet. Swelling often occurs on the back of the hands and feet and moves into the fingers and toes. Hand-foot syndrome may be the first sign of sickle cell anemia in infants.
Sickle cells can block the small blood vessels in the hands or feet. This condition is called hand-foot syndrome. It can lead to pain, swelling, and fever
Splenic Crisis
The spleen is an organ in the abdomen. Normally, it filters out abnormal red blood cells and helps fight infection. In some cases, the spleen may trap cells that should be in the bloodstream. This causes the spleen to grow large and leads to anemia.
If the spleen gets too clogged with sickle cells, it won't work right. This can cause the spleen to shrink. If this happens, you may need blood transfusions until your body can make more cells and recover.
Infections
Both children and adults who have sickle cell anemia have a hard time fighting infections. This is because sickle cell anemia can damage the spleen, an organ that helps fight infections.
Infants and young children who have damaged spleens are more likely to get infections that can kill them within hours or days. Pneumonia is the most common cause of death in young children who have sickle cell anemia.
Meningitis, influenza, and hepatitis are other infections that are common in people who have sickle cell anemia.
Acute Chest Syndrome
Acute chest syndrome is a life-threatening condition linked to sickle cell anemia. It's similar to pneumonia. The condition is caused by an infection or sickle cells trapped in the lungs.
People who have this condition usually have chest pain and fever. They also often have abnormal chest x ray results. Over time, lung damage from acute chest syndrome may lead to pulmonary arterial hypertension (PAH).
Pulmonary Arterial Hypertension
Damage to the small blood vessels in the lungs makes it hard for the heart to pump blood through the lungs. This causes blood pressure in the lungs to rise.
Increased blood pressure in the lungs is called pulmonary arterial hypertension, or PAH. Shortness of breath and problems with breathing are the main symptoms of PAH.
Delayed Growth and Puberty in Children
Children who have sickle cell anemia often grow more slowly than other children. They also reach puberty later. A shortage of red blood cells causes the slow growth rate. Adults who have sickle cell anemia often are slender or smaller in size than other adults.
Stroke
Two forms of stroke can occur in people who have sickle cell anemia. One form occurs when a blood vessel in the brain is blocked. The other form occurs when a blood vessel in the brain bursts.
A stroke can cause learning disabilities and/or lasting brain damage, long-term disability, paralysis (an inability to move), or death.
Eye Problems
Sickle cells also can clog the small blood vessels that deliver oxygen-rich blood to your eyes. This can damage the retinas-thin layers of tissue at the back of your eyes. The retinas take the images you see and send them to your brain.
Without enough blood, the retinas will weaken. This can cause serious problems, including blindness.
Priapism
Males who have sickle cell anemia may have painful and unwanted erections. This condition is called priapism (PRI-a-pizm). It happens because the sickle cells block blood flow out of an erect penis. Over time, priapism can damage the penis and lead to impotence.
Gallstones
When red blood cells die, they release their hemoglobin. The body breaks down this protein into a compound called bilirubin. Too much bilirubin in the body can cause stones to form in the gallbladder.
Gallstones may cause steady pain that lasts for 30 minutes or more in the upper right side of the belly, under the right shoulder, or between the shoulder blades. The pain may happen after eating fatty meals.
People who have gallstones may have nausea (feeling sick to the stomach), vomiting, fever, sweating, chills, clay-colored stools, or jaundice (a yellowish color of the skin or whites of the eyes).
Ulcers on the Legs
Sickle cell ulcers (sores) usually begin as small, raised, crusted sores on the lower third of the leg. Leg sores occur more often in males than in females. These sores usually appear between the ages of 10 and 50.
The cause of sickle cell ulcers isn't clear. The number of ulcers can vary from one to many. Some heal quickly, but others persist for years or come back after healing.
Multiple Organ Failure
Multiple organ failure is rare, but serious. It happens if you have a sickle cell crisis that causes two out of three major organs (lungs, liver, or kidney) to fail.
Symptoms of this complication are a fever and changes in mental status, such as sudden tiredness and loss of interest in your surroundings.
• Sickle cell anemia has no widely available cure. However, there are treatments for the symptoms and complications of the disease. Treatments include medicines, fluids, and procedures. Bone marrow transplants may offer a cure in a small number of cases.
• You can't prevent sickle cell anemia because it's an inherited disease. However, you can take steps to reduce its complications.
• With good health care, many people who have sickle cell anemia can live productive lives. They also can have reasonably good health much of the time and live longer today than in the past. If you have sickle cell anemia, it's important to adopt or maintain a healthy lifestyle, take steps to prevent and control complications, and learn ways to cope with pain.
• If you have a child or teen who has sickle cell anemia, you can take steps to learn about the disease and help your child manage it.
• Researchers continue to look for new treatments for sickle cell anemia. These include gene therapy and improved bone marrow transplants.
Medicines and Fluids
Mild pain often is treated with over-the-counter medicine and heating pads. Severe pain may need to be treated in a hospital.
The usual treatments for acute (short-term) pain crises are fluids and pain-killing medicines. Fluids help prevent dehydration, a condition in which your body doesn't have enough fluids. Fluids are given either by mouth or through a vein.
Common medicines used to treat pain crises include acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and narcotics such as meperidine, morphine, oxycodone, and others. (Narcotic abuse and addiction are issues that must be considered in any pain control plan.)
Treatment for mild-to-moderate pain usually begins with NSAIDs or acetaminophen. If pain continues, a narcotic may be added. Moderate-to-severe pain is often treated with narcotics. The narcotic may be used alone or with NSAIDs or acetaminophen.
Hydroxyurea
If you have severe sickle cell anemia, you may need a medicine called hydroxyurea. This medicine helps reduce the number of painful crises you have. Hydroxyurea is used to prevent painful crises, not to treat them when they occur.
Given daily, this medicine reduces how often painful crises and acute chest syndrome occur. People taking the medicine also need fewer blood transfusions and have fewer hospital visits.
Early studies of hydroxyurea in children show that they have improved growth. These studies also suggest that this medicine may help preserve organ function.
Hydroxyurea can cause serious side effects, including an increased risk for dangerous infections. People who take hydroxyurea must be carefully watched. Your doctor may need to adjust the dose of this medicine to reduce the risk for side effects.
Nicosan
From Wikipedia, the free encyclopedia
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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).
Contents
[hide]
• 1 Development history
• 2 Research findings
• 3 Footnotes
• 4 External links
[edit] 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, 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.
[edit] 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."[1]
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" .[2]
[edit] Footnotes
1. ^ "Xechem International - Annual Report". December 31 2005. http://sec.gov/Archives/edgar/data/919611/000114420406015544/v040579_10ksb.txt. Retrieved on 2006-07-21. - submission to U.S. Securities and Exchange Commission
2. ^ Iyamu E, Turner E, Asakura T (2002). "In vitro effects of NIPRISAN (Nix-0699): a naturally occurring, potent antisickling agent.". Br J Haematol 118 (1): 337–43. doi:10.1046/j.1365-2141.2002.03593.x. PMID 12100171.
[edit] External links
• http://www.xechemnigeria.com Xechem Pharmaceuticals Nigeria homepage
NICOSAN™ is a non-toxic, Phyto-pharmaceutical, product for the treatment of Sickle Cell Disease (SCD). NicosanTM is obtained from the mixture of four Nigerian plant materials e.g. Piper guineese (Seeds), Pterocarpus Osun (Stems), Eugenia caryophyllum (Fruits), Sorghum bicolor (Leaves), in a standard ratio which produce a hygroscopic, reddish-brown powder with a pungent odour.
In July, 2002, Xechem acquired exclusive worldwide license from the Ministry of Health, Federal Government of Nigeria to develop and market NICOSAN™ (HEMOXIN™ in the US).
NICOSAN™ (HEMOXIN™) was shown to be a safe and efficacious medicine for the management of patients with Sickle Cell Disease. As published in the May 2003 issue of the British Journal of Hematology, Dr.Toshio Asakura and colleagues from Children's Hospital of Philadelphia (CHOP), USA and the University of Pennsylvania demonstrated the anti-sickling effects of NICOSAN™ (HEMOXIN™) in transgenic mice.
The quality and standardization of the medicine has been tested and proved by High Performance Liquid Chromatography (HPLC) and bioassay.
NICOSAN™ Characteristics
A 100 % Nigerian indigenous Product.
Product available in Capsules, pleasant tasting with no known side effects.
Dose determined and Clinical Trials conducted.
The pricing strategy will favor the poor and underprivileged.
BENEFITS OF NICOSAN™
1. It is used for prophylactic management of sickle cell disease (SCD).
2. It has potent anti sickling effect on sickled erythrocytes, obtained from patients with SCD and on transgenic mice that produced human sickle hemoglobin, thus useful in preventing painful crisis experienced by SCD patients.
3. It reduces hypoxic stress experienced by SCD patients (due to trapping of sickle cell in lungs), drastically.
4. It removes the incidence of blood transfusion in SCD PATIENTS.
5. It prevents clinical sequel (i.e. painful crisis).
6. It prevents ocular damage
PRESENTATION
NicosanTM comes in two different strengths:
250mg (Children Dose)
350mg (Adults Dose)
It is presented as 30 capsules, packaged in 60ml, HDPE bottles
DOSAGE
Adult Dose:
One (1) capsule (350mg) daily at meal time with water.
Child Dose:
One (1) capsule (250mg) daily at meal time with water.
SIDE EFFECTS
Rare:
Mild non- itching muscular rash
Mild headache.
TOXICITY
- Non Toxic
- Higher doses of 2000mg 5000mg/kg LD50 (A lethal Dose at which 50% of the population of experimental mice were expected to die), there was no death recorded.
- No kidney or liver damage was observed both in human volunteers and in experimental animals during and after the clinical trials, the drug is safe in humans at the
recommended dose.
CONTRAINDICATION
There is no known contra-indication in both mice and human to all the active ingredients. The potash used for extraction and the binding agent (Lactose) are safe for human consumption.
No health hazard was observed, when administered in the proper dosage form.
INTERACTION
It can be safely combined, with other drugs, even the cytotoxic drugs like Indinavir, Zidovudine, Lamivudine and Vevirapine used in the management of HIV/AIDS.
Paracetamol was found to increase the invivo concentration of NicosanTM care must be taken, when they are co administered.
TERATOGENECITY
There is no known teratogenic effect produced by NicosanTM, even some pregnant women who opted (against clinician's advice) to continue taking NicosanTM had normal babies.
STORAGE CONDITION
To be stored in a dry clean place storage temperature is 25oc. Protect from moisture and humidity.
CONCLUSION
NICOSANTM is an effective and safe drug of choice for the management of sickle cell disease (SCD)
NICOSAN for the Treatment of Sickle Cell Disease
In clinical trials NICOSAN eliminated crises in 80% of patients and in the refractory 20% reduced crises by half.
This relatively new treatment for sickle cell being
produced in Nigeria by an American company called NICOSAN®,
it’s proprietary name is NIPRISAN® was developed on the
premise of traditional Nigerian plant based medicinal practices
for the treatment of sickle cell disease. 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..
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 forward and post this information
to any person, blog or website where persons affected 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
For additional information about this drug you can visit the
Xechem Nigeria company website.
Kind regards,
Larrywh
P.S.
*Mr. Monty Forthun
Email: lamontef@yahoo.com
Hi!
All the best!
Well said!
If justice is going to be upheld by the Nigerian Government and our judge, Nicosan will be produced the way it should be done---efficiently and effectively, with the scientific leadership of Dr. Pandey and a new Board of Directors for the common benefits of a lot of SCD sufferers and the shareholders. I still have a lot of faith in the American stock market system. It is designed to reward investors who support the growth and success of any corporation. There are checks and balances built into the system even though the system may not be perfect. It would be a good example of humanitarian success for President Obama to cite for many years to come. XEKEM can still be the pride and joy of the USA and the Nigerians. Scientific research and cooperation can cross borders and boundaries in our global village. Corporate scandals can happen anywhere in the world. All we need is to let our conscience be our guiding light for a better world and act accordingly. As a longterm supporter and investor of XKEM, I am looking forward to receiving the blessing of the creditors and to have them come on board with us. Let's pray and hope that Monty and his team shall prevail!
Have a Happy Easter, everyone!
Thanks Monty!
It's good to hear from you again!
We're all ears!
Kind regards...
I salute to the judge and those SEC officials for taking the time to scrutinize the plot of Dr Swift and his collaborators to screw the shareholders.
Let there be JUSTICE!!!
Imf,
Thanks very much for your update! Way to go......
Thank God we do have transparency after all! I believe the judge will draw parallel from bonuses versus consultation fees and abused funds.
In AIG, there are those up at the top that robbed the tax payers and give themselves huge bonuses. The government shall see to it that those bonuses will be voluntarily returned to the rightful owners --- the tax payers.
In XeChem, there are those sitting on the Board who repeatedly robbed the company and shareholders who have been trying hard to help those debilitated by Sickle Cell Disease. Frauds were committed while breaking all the regulations required of a publicly traded company. The question is: how should those consultation fees and abused funds be returned?
The day of reckoning is near! LET JUSTICE PREVAIL!!!