-------------------- All post are my opinion. Do your own DD. Who's clicking your buy/sell button!? Posts: 7800 | From: Virginia | Registered: May 2006
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Xechem Receives Orphan Drug Designation From The FDA For Its Anti-Sickling Drug 5-HMF Tuesday June 6, 6:30 am ET
NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--June 6, 2006--Xechem International, Inc. (OTC BB: XKEM - News) Xechem International announced today that it has received Orphan Drug designation from the U.S. Food and Drug Administration (FDA), Office of Orphan Drug Products Development, for the five-membered heterocyclic anti-sickling compound known as 5-HMF for the treatment of patients suffering from sickle cell disease (SCD).
ADVERTISEMENT Research led by Dr. Donald Abraham of Virginia Commonwealth University (VCU) has shown 5-HMF to be "the best potential anti-sickling agent in 30 years of sickle cell research", performed by his group. 5-HMF not only is a natural product with very little, if any, toxicity, but it has a high affinity for sickle cell hemoglobin. It is also very active in genetically modified mice as shown by Dr. Toshio Asakura, Director, and his colleagues at the NIH-NHLBI Sickle Cell Disease Reference Laboratory at the Children's Hospital of Philadelphia, University of Pennsylvania.
According to Xechem's Chairman and CEO, Dr. Ramesh Pandey, "We are pleased with the FDA's decision granting Orphan Drug Designation to 5-HMF. This puts Xechem into a unique position where the company will have two drugs in the pipeline for treating patients with sickle cell disease. 5-HMF is a new type of drug that interacts specifically with intracellular hemoglobin without interacting with other proteins in the body. Today there are no non-toxic drugs available on the market to treat SCD. We are actively proceeding with our first drug (NICOSAN(TM)) in the hope of bringing it to the Nigerian market immediately following Nigerian regulatory approval. We are also preparing the Investigational New Drug (IND) application for 5-HMF for submission to the FDA in the coming months."
About Orphan Drug Designation
-------------------- "Great Day for Up!"....Dr. Seuss Posts: 3387 | Registered: Mar 2006
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The granting of the orphan drug status is designed to encourage the development of drugs which are necessary but would be prohibitively expensive/un-profitable to develop under normal circumstances.
In the United States, an orphan drug is any drug developed under the Orphan Drug Act of 1983, a federal law concerning rare diseases ("orphan diseases"), defined as diseases affecting fewer than 200,000 people in the United States or low prevalence is taken as prevalence of less than 5 per 10,000 in the community . This has been adopted as a subclause of the Food and Drug Administration (FDA) regulations. Because medical research and development of drugs to treat such diseases is financially disadvantageous, companies that do so are rewarded with tax reductions and a monopoly on that drug for an extended time (twenty years). Under the act many drugs have been developed, including drugs to treat HIV/AIDS, cystic fibrosis, and snake venom.
A similar status exists in the European Union, administered by the Committee on Orphan Medicinal Products of the European Medicines Agency.
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This has been running nice the last few days...If it breaks .030 it may keep going. Come on .030!
Posts: 2498 | Registered: Mar 2006
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Anyone catch the bounce/shake today at 10:30?
The shake yesterday was manipulated by 3 market makers in the last hour of trading. The rest of 'um stayed at .028 while three brought it down. It was easy to spot on the L2's.
-------------------- Buy Low. Sell High. Posts: 10754 | From: The Land Of The Giants | Registered: Feb 2005
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Damn peaser, I hope you took your profits, I warned ya.. Hey GNLB hit 1.70 sure hope people sold and didn't hold, that was a no-brainer pull back.
Posts: 10729 | From: oregon | Registered: Feb 2005
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We'll see. Meeting a lot of resistance. maybe people 2nd guessing nigeria as a starting point for this venture.
-------------------- All post are my opinion. Do your own DD. Who's clicking your buy/sell button!? Posts: 7800 | From: Virginia | Registered: May 2006
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March 3rd, 2006 Obasanjo to launch locally produced sickle cell drug
President Olusegun Obasanjo will by June launch NIPRISAN (HEMOXIN(TM)), the locally produced drug for sickle cell disorder. PATIENCE OGBE Abuja
The president will also use the occasion to commission Xechem International Inc. factory in the country in a move seen as a landmark investment in Nigeria. The company owns the exclusive rights to NIPRISAN
The drug NIPRISAN (HEMOXIN(TM), which is at present, undergoing final stage of registration with NAFDAC is a phyto-pharmaceutical drug for the treatment of patients suffering from Sickle Cell Disease (SCD). SCD is an insidious and painful genetic blood disorder often resulting in death at an early age.
Science and Technology Minister, Turner Isoun who disclosed this in Abuja noted that location of the factory in Nigeria would further crash the price of sickle cell drugs in Nigeria.
Isoun stated that Niprisan (HEMOXIN(TM)) was a drug cocktail, with phyto-pharmaceutical composition of four traditional plants extracted in a proprietary process. The licensor of the technology is the National Institute for Pharmaceutical Research and Development (NIPRD) in Abuja, Nigeria.
Nigeria is said to have the highest sickle cell disease population in the world ranging from four to six million representing roughly three to five percent of the country's population.
Isoun spoke at the inaugural meeting of the Ministers’ Council for the National Biotechnology Development Agency (NABDA) where he also called on the government to involve more laboratories for the control and analysis of the bird flu menace.
On the situation of bio technology in Nigeria, he called on the stockholding agencies to ensure that Nigeria benefits from the judicious and safe use of modern biotechnology.
"Biotech is a gold mine and important to this nation. Almost every Nigerian is affected by the operations of biotech. To be able to achieve all these, we will require the concerted political will and a focused leadership drive. It is therefore the collective responsibility of all of us key stakeholders of modern biotechnology to join forces in realizing this vision.
It is my belief that this collective mission will not jeopardize our separate mandates but will promote the effective coordination of our effort towards achieving the same ultimate goal."
To achieve the nation’s targets in biotech, the Director General of the National Biotechnology Development Agency (NABDA), Bamidele Solomon called for the establishment of biotechnology development fund.
The fund, he stressed, could help the nation support competent researches and be ready to tackle problems like the bird flu.
He also disclosed that Nigeria in collaboration with Trinity Biotech of the Republic of Ireland will establish a facility at SHESTCO Abuja for the production of test kits for HIV/AIDS and other diseases like HB, malaria and so on.
He added that the Federal Government has approved the sum of $28 million as counterpart commitment for the project.
He also spoke of Nigeria’s collaboration with Shantha Biotechnics Limited of India for the establishment a facility for the production of Hepatitis B vaccine and other vaccines for related diseases like typhoid, polio, DTP and related ailments.
"Government approved the sum of N10 Million in the 2004 capital budget to support carrying out of a detailed feasibility study and fulfilling other MoU requirement."
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in at .0115 and 0112 gonna cover tomorrow at .043
-------------------- All post are my opinion. Do your own DD. Who's clicking your buy/sell button!? Posts: 7800 | From: Virginia | Registered: May 2006
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I put in a back fill at .018 it'll probably fill the way this thing moves around. commisions says I'm averaged at .0146 my 0115 was act. .018 ...I shouldn't do this without my glasses lol.
-------------------- All post are my opinion. Do your own DD. Who's clicking your buy/sell button!? Posts: 7800 | From: Virginia | Registered: May 2006
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didn't get my fill and looks like it aint gonna fill. Cool with me!
-------------------- All post are my opinion. Do your own DD. Who's clicking your buy/sell button!? Posts: 7800 | From: Virginia | Registered: May 2006
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XKEM continues to move in the right direction,gaining momentum. Closed Friday * .029 Thats a 166% increase in less than 2 weeks.
-------------------- How long a minute is depends on what side of the bathroom door your standing. Posts: 8 | From: California | Registered: Jun 2006
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