is dreaming of Nicosan4All ;-)
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I do believe you would want to qualify that post with a publication date of a decade or so ago? That does not sound like current news to me - but you could fool me lol
You know, we have all been speculating about the size of the new XeChem Park being erected and outfitted at Shestco - and how it is likely to be used for the production of other drugs because surely it is too large for just Nicosan. There is definitve proof that this is indeed the case with this quote from the EXPORT-IMPORT BANK OF THE UNITED STATES:
REPORT TO THE U.S. CONGRESS ON SUB-SAHARAN AFRICAFISCAL YEAR 2007
The Xechem Pharmaceutical Plant will also produce other products for the treatment of Malaria, HIV/AIDS and related complications.
Seems to me we can stop speculating about this aspect at least and can anticipate that XPNL WILL have a hand in various other phytomedecines during the next five years and onward imo.
http://www.exim.gov/products/special/africa/pubs/FY2007ReporttoCongress-SSA.pdf
FIRST ANNOUNCEMENT WOCMAP IV
4TH WORLD CONGRESS ON MEDICINAL AND AROMATIC PLANTS–USING PLANTS TO BENEFIT PEOPLE
CAPE TOWN, SOUTH AFRICA,
9-14 NOVEMBER 2008
INTRODUCTION
In a meeting of the Secretariat of the International Union of Biological Sciences (IUBS) in Paris, nine international
organizations decided to establish an international non-governmental body entitled: International Council for Medicinal
and Aromatic Plants (ICMAP) [www.icmap.org] with the general objective of promoting international understanding and
cooperation between national and international organizations on the role of medicinal and aromatic plants in science,
medicine and industry, and to improve the exchange of information between them.
One of the functions of ICMAP is to arrange a world conference on medicinal and aromatic plants [WOCMAP] every five
years. The first was in Europe [Maastricht, Netherlands 1992], the second in South America [Mendoza, Argentina 1997],
and the third was held in Asia [Chiang Mai, Thailand, 2003]. Due to the geopolitical situation the participation was
remarkably lower than at previous WOCMAP conferences, nevertheless more than 600 attendants were present. The
proceedings of WOCMAP III were published in six volumes of Acta Horticulturae of the International Society for
Horticultural Science.
ICMAP Bureau has invited the Leader of the Phytomedicine Programme at the University of Pretoria to organize
WOCMAP IV in South Africa in 2008. We expect in the order of 1200 delegates for WOCMAP IV.
.
DETAILS
The organizing committee and sponsors warmly invite you to attend WOCMAP IV. The conference will be held at the
Cape Town International Convention Centre (CTICC) in Cape Town from 9-14 November 2008. The CTICC opened in
2003 and is ideally located in the heart of the panoramic city of Cape Town and within walking distance of an abundance
of superb accommodation and many tourist attractions, such as the world-renowned Victoria & Alfred Waterfront
(www.capetownconvention.com)
PROGRAMME
International Scientific Advisory Committee and Plenary speakers to be announced soon.
THEMES AND LOCAL ORGANIZING COMMITTEE/SCIENTIFIC COMMITTEE RESPONSIBLE FOR PROGRAMME.
Theme 1: Biodiversity prospecting and ethnopharmacology. Prof. Neil Crouch, South African National Biodiversity Institute,
Durban
Theme 2: Conservation, cultivation and sustainable use. Prof. Hannes van Staden, Leader Research Centre for Plant
Growth and Development, University of KwaZulu-Natal.
Theme 3: Perspectives in natural products chemistry. Prof. Berhanu Abegaz, Chemistry, University of Botswana
Theme 4: Targeted screening approaches for drugs and
cosmetics.
Prof. Marion Meyer, Botany, University of Pretoria.
Theme 5: Quality, efficacy and safety of phytomedicines and
phytocosmetics.
Prof. Alvaro Viljoen . Pharmaceutical Sciences, Tshwane
University of Technology, Pretoria
Theme 6: Developments in industrial processing of MAPs. Mr Ulrich Feiter, Managing Director Parceval, Wellington
Theme 7: The economics and marketing of medicinal and
aromatic plants.
Mr Myles Mander, Consultant, Durban
Theme 8: New developments in laws and regulations for the
use of MAPs. Trade and industry perspective.
Mr Thomas Brendler, Managing Director Plantaphile, Berlin
Theme 9: Traditional medicine and health systems for new
and old diseases.
Prof. Ben-Erik van Wyk, Botany, University of Johannesburg
Theme 10: Nutraceuticals. Prof. Ameenah Gurib Fakeem, Pro-Vice Chancellor, University of
Mauritius
Theme 11: Veterinary medicine: Prof. Kobus Eloff, Leader Phytomedicine Programme,
Paraclinical Sciences, University of Pretoria.
Theme 12: Diverse aspects not accommodated in other
themes.
Prof Anthony Afolayan, Botany, University of Fort Hare
WHY YOU SHOULD CONSIDER ATTENDING.
• Leading scientists in the world in this area will be invited to present plenary lectures focussing on developments in
different areas over the past five years and to discuss possible future developments and fruitful areas for research.
• All abstracts will be published in a special issue of South African Journal of Botany and will be listed in ISI
databases.
• Many different aspects of medicinal and aromatic plants will be discussed with delegates from all continents. We
expect in the order of 1200 delegates.
• There will be a MAP trade fair and special exhibitions running alongside the conference. These will include displays
of African herbal products, ingredients and publications and stands of international companies and organisations
offering technical and financial help to the MAP sector
• Sir Francis Drake called Cape Town “the fairest cape in the whole circumference of the earth” due to its natural
beauty.
• Carl Linnaeus called it heaven on earth due to the astounding floral diversity. We plan to hold an early evening
picnic at the world famous Kirstenbosch Botanical Garden on the slopes of Table Mountain.
• Cape Town has recently been voted as one of the prime tourist destinations in the world and previously as Best
City in Africa and the Middle East, Favourite Foreign City, Best City to Eat Out and One of the World’s Top 8
Creative Cities.
• The climate in November is excellent with temperatures ranging from 15-270C and 11 hours of sunshine per day.
• There will be a very interesting accompanying person’s programme.
• There will be exciting pre and post congress excursions to different places in South Africa – a world in one country.
DEADLINES
Abstract submission: 15 May 2008
Information on acceptance of abstract: 1 July 2008
Registration with payment to ensure inclusion of Abstracts in published Conference abstracts: 15 July 2008
Cancellation with full refund less bank charges: 15 July 2008
Cancellation with 75% refund less bank charges 15 Sept. 2008r
REGISTRATION COSTS
Before 15 May 2008 Before 15 July 2008 After 15 July 16, 2008
Delegate from high income economy countries* €360 €400 €460
Delegate from other countries €288 €320 €380
Students (with proof of registration) €234 €260 €320
Accompanying person €81 €90 €110
*See World bank definition at http://web.worldbank.org
SOCIAL FUNCTIONS
Registration cost includes: welcoming reception probably in the Castle of Good Hope, evening picnic at Kirstenbosch
Botanical Garden and Gala Dinner with traditional African dances and entertainment at a wine farm near Stellenbosch.
SPONSORS
Phytomedicine Programme, Faculty of Veterinary Science, University of Pretoria; www.up.ac.za/phyto
ICMAP International Council for Medicinal and Aromatic Plants; www.icmap.org
AAMPS; Association for African Medicinal Plant Standards; www.aamps.org
To be updated
COLLABORATING SOCIETIES AND ORGANIZATIONS
To be updated
CONTACT
Please let us know by e-mail (wocmap@up.ac.za) if you are interested in receiving the second circular.
Kobus Eloff,
Chairman Organizing Committee
http://www.phcog.org/WOCMAP4.pdf
We have quite a few shareholders here who have this gift of clarity in thought and expression and it surely is these visionary ablilities that are needed in shining light on XeChem.
Many of us here have felt that the XeChem Park being built has such enormity built into it that these cannot realistically be expecte to be solely for the production of Nicosan. My understanding is that the NIPRD facilities are minute in comparison to what is being assembled here at the SHEDA complex, and as we know, those NIPRD facilites have been recently been the subject of a rejuvination.
I fully believe that Nigeria wants/needs Nicosan as their phytopharmaceutical flagship. Way too much time, energy and money has been invested in the various components to being this drug to market in it's present form. There have been numerous spin-off benefits too, that will be employed in future developments. One of these is the formation of MOU's between herbalists (TM's) and Institutions of development.
---
Prof. C. O. N. Wambebe, Director General of the National Institute for Pharmaceutical Research and Development (NIPRD) at Abuja, Nigeria, provided the agreement which NIPRD enters into with the herbalist whose knowledge they use to develop drugs (see Annex 3.4.2). The agreement provides a very clear and comprehensive framework for obtaining the informed consent of the local herbalist for using his or her knowledge to develop commercial products. The NIPRD is obliged to inform the herbalists if the information provided by the herbalists already exists within the Institute or has been provided by other experts. The Institute is also obliged to furnish to the herbalist in writing, the results of every scientific test or analysis carried out on the material received from the herbalist.
The INSTITUTE shall apply for and obtain or cause to be granted and obtained the letters of patent on the products IN THE NAME OF THE INSTITUTE after the same has been developed and processed PROVIDED THAT THE CONSULTANT HERBALISTÆS NAME BE INCLUDED IN THE PATENT subject to the conditions hereinafter set forth.
Such a use of patents for the direct sharing of benefits arising from the use of biological resources and associated knowledge has not been found in any other public or private sector institutions as yet. The registration of trademarks and/or designs in any product supplied by the herbalist to the Institute are supposed to vest with the Institute from the date of delivery of the product by the consultant herbalist. However, the discovery of the herbal products by the consultant herbalists shall be acknowledged as such in the correspondence and literature, publications of the product as much as practicable.
The Institute would provide to the herbalists at least ten per cent of the net profit as royalty. In the case of the Bio-resources Development and Conservation Programme (BDCP), such explicit agreements have not yet been developed, although in spirit they have tried to follow these concepts and have been pleading for reciprocity and accountability in such transactions for almost twenty years.
tp://www.sristi.org/papers/nigeria_case.doc.
---
Years ago there developed recognition of TM's knowledge around the world and one of the US based organizations has direct application for knowledge gained from NIPRD's growth. The International Cooperative Biodiversity Group (ICBG), sponsored by the National Institute of Health, the National Science Foundation, and the US Agency for International Development, have a programme for conservation and sustained economic development through drug discovery.
One of the unique features of this ICBG is that the emphasis is on discovery and development of compounds for tropical diseases such as malaria, leishmaniasis and other parasitic infections rather than only for the treatment of diseases of global importance such as cancer, AIDS and metabolic disorders. The program is committed to the development of low-cost phytomedicines, in addition to the isolation of lead compounds for drug discovery. à the ICBG - Drug Development and Conservation of Biodiversity in West and Central Africa aims to demonstrate that sustainable drug development is a viable alternative to the common destructive activities such as timber harvesting, as a source of forest income for local communities.
The programme has used a combination of four approaches, namely the development of drugs which address the priority health needs of the United States and the participating countries, the inventorization of native species and indigenous knowledge, capacity building to achieve the goals of the research programme, and strengthening the scientific infrastructure in the host developing country.
They also encourage collaboration via postings from individuals and groups interested in collaborating on a 2007 ICBG application:
Expertise/interests: The Center has four areas of interest:
• Traditional Knowledge and Biotechnology.
• Identification, Characterization, and Monitoring of Biodiversity.
• Landscape Approach to Biodiversity Conservation.
• Sustainable Use of Biodiversity.
• Knowledge Sharing.
Potential role in project: The multidisciplinary team at IBSAR has expertise in identifying plants and molecules that possess bioactive properties. Many of the plants have a well established role in traditional Arab medicine and culinary practices. Plants from the region are collected and cultivated, extracted, and tested for their potential effects on major diseases such as cancer, inflammation, microbial infections, and to determine where they might have preventative healthcare uses. In the past few years, taxonomic identification and biological screening of water and methanolic extracts of plants against several normal and tumor cell lines led to the selection of several plants possessing potent bio-activites. Bio-guided fractionation procedures of plant extracts against a panel of inflammation, colon, skin, and lymphoma cancer cells led to the isolation and the identification of anti-inflammatory and anti-cancer compounds. IBSAR recognizes the tight coupling of chronic inflammatory diseases and cancer and this lends itself towards bio-prospection for both preventive and therapeutic cancer treatments. ibsar ongoing research aims at utilizing well-established molecular, cellular and animal models and markers of cancer and inflammation to explore the potential of Lebanese endemic plants in prevention and treatment. Skin, colon, and blood cancers cell culture models are used and those are coupled to in vivo models. In addition, In vitro cell models, a rodent mammary and intestinal cell models, and an in vivo rodent model of chronic inflammatory bowel disease (IBD) are also used to test for anti-inflammatory effects.
http://www.icbg.org/pub/collaboration.php
-
The programme is administered by the Fogarty International Center at the US National Institute of Health. Unlike most other projects, in this programme most of the processing and biological testing of the plant material is performed within the Group rather than in the institutions outside the Group. The idea was to build a team of scientists who will discover lead plants and develop active molecules into drugs. Selected plant products will then be developed to the pre-clinical stage before starting negotiations with commercial partners.
http://www.fic.nih.gov/index.htm
-
Additionally, there now appears to be three Centres for Phytomedicine Drug Development in the greater Abuja area. There is the XeChem Park at the SHEDA Complex, the upgraded NIPRD facility and The International Centre for Ethnomedicine and Drug Development (InterCEDD). The latter conducts an integrated research program for drug development, and commercialization of potentially useful natural products.
InterCEDD provides a full service Phytomedicine research facility, that standardizes traditional remedies with clearly demonstrated safety and efficacy profiles.
The core research focus of InterCEDD includes:
Ethnomedicine
Microbiology
Pharmacognosy
Medicinal Chemistry
Pharmacology and Drug Metabolism
InterCEDD has capabilities to perform several research and scientific procedures which include:
Chemical analysis
Standardization of botanicals
Processing and standardization of phytomedicine
Organic certification and authentication of cultivated botanicals
Biological Assays
Access to a full herbarium and ethnobotanical database
A library of extracts and isolates of African medicinals for drug discovery
For Ethnomedical validation the centre employs a unique
methodology which consists of:
- Conducting surveys of plants used for indigenous treatments
- Subjecting the list to biological and chemical dereplication
- Using an innovation system know as COBEL
(Clinical Outcome Based Ethnomedical Leads)
Our basic approach consists of the following steps:
Conducting surveys of plants used for indigenous treatment of diseases that have clearly identified symptoms or symptom-complexes;
Subjecting the list to biological and chemical de-replication and selecting only those plants that are used across large communities, areas or among different ethnic groups and the plants did not belong to groups already designated undesirable by several criteria;
The plants still in current use as traditional remedies are evaluated using the Clinical Outcome-Based Evaluation;
The few plants that are positive in the COE study are then selected for in-dept laboratory studies. Our method has led to the identification of several plants as potential therapeutic agents.
http://www.nextdaysite.net/intercedd/index.htm
As you say, the IPO will come because this is a Nigerian Effort in response to a Nigerian Need that has a Nigerian Solution. Not only does it make economic sense, but there are also significant political rewards. I suspect we see little mention of Nicosan specifics because of the political need to provide transparency in favoratism. Perhaps even there are negiotions ongoing. We do not know, but the silence from here and across the pond means something. Nicosan and XPNL will do well imo and if XeChem Intl goes Bust!, XPNL will quickly be autonomized, subsiduary or not. I do not believe this to happen because it would appear that XPNL is all that XIntl has today.
Meantime various African countries continue to recognize the potential of TM/TK and natural remedies' health and economic impact.
Intellectual property, partnerships and people
by Joseph Wekundah, Biotechnology Trust Africa (BTA), Nairobi
This article examines the legal arrangements with respect to the products resulting from public-private research partnerships, and the implications for small farmers in East Africa.
Most countries in East Africa have modelled their intellectual property laws on international conventions and agreements that are intended to promote creativity through the granting of intellectual property rights (IPRs). These include industrial property laws (covering patents, trademarks, geographic indications, etc.), copyright laws, and plant breeders' rights. Kenya has developed and enacted legal frameworks for all of these areas, while Uganda and Tanzania have copyright and trademarks laws, but use the African Regional Industrial Property Organization (ARIPO) for their industrial property laws.
---
Remodeling traditional & indigenous knowledge
by Cindano C. Gakuru
Knowledge, in all its forms, is a means to the attainment of economic self-determination and self-reliance. Every aspect of human activity in terms of the use of knowledge is becoming a vital component of socio-economic and political interaction. This has prompted many a commentator to proclaim that we have entered the 'Information Age'. Information is power, so the cliché goes. However, not all knowledge is perceived to be power generating; not all knowledge is perceived to be providing a competitive edge. Such is the case with traditional knowledge (TK). For a considerable period, TK has been considered little more than a nostalgic remembrance of our varying pasts, being preserved only as superstitious folklore best relegated to museums. Thankfully this is changing as TK has recently assumed a major significance globally especially with regard to knowledge of genetic resources and their contribution to pharmaceutical and agricultural industries.
http://knowledge.cta.int/en/content/view/full/3006
Anyway, just rambling along on this Sunday ... but time to get on dealing with other tasks for what has been a Summer-like weekend here in Ontario's Near North country.
A beautiful mind is such a sexy thing! (lol-eom)
Experts Call For Increased Budget For Health
Stella Eze
18 April 2008
Governments of West African countries have been asked to dedicate 15 per cent of their budgets towards revamping the health sector. This call was made by stakeholders at the Sub-Regional Meeting on ‘Ownership and Leadership of Sexual and Reproductive Health in West Africa’, which ended on Tuesday in Abuja.
In a communiqué, the participants argued that adequate funding of the health sector would help raise the health status of the people in the region, and thus put the countries on the path to achieving the Millennium Development Goals. They also called for increased public private partnership in the provision of health services, increased training and retraining of health service providers and a conducive working environment that will ensure the retention of trained personnel.
The meeting convened by the International Planned Parenthood Federation,, Africa Region and West Africa Health Organization (WAHO)/ECOWAS was attended by delegates from Burkina Faso, The Gambia, Ghana and host country Nigeria, parliamentarians and development partners.
http://www.leadershipnigeria.com/product_info.php?products_id=26207&osCsid=0d670e53ef66637c6cf224909c4b76dc
Phew! Waited all day! Yup, I'm 55!
... for another month
We are exploring a network to develop new medicines for neglected developing world diseases...
Statement to WHO Executive Board
24 January 2008 Geneva,Switzerland
R&D-based Pharmaceutical Industry’s Growing Engagement
in Health Partnerships for the Developing World
International Federation of Pharmaceutical Manufacturers & Associations
• A Network for Neglected Disease Discovery. We are exploring a network to develop new medicines for neglected developing world diseases, through sharing of disease targets between industry and other research groups, allowing them to be screened against company compound libraries. Work is currently focused on defining detailed operating principles and adding to the number of companies that have already agreed to collaborate.
• A Sustainable R&D Funding Initiative. This aims to lay the foundations for adequate,
sustainable and predictable funding for R&D into neglected diseases, through realistic
estimation of additional funding needed to complete the portfolios required to deliver
sufficient numbers of new medicines, and evaluation of appropriate mechanisms for raising
funds, prioritizing their allocation and governance. It is also working to raise awareness and
build consensus amongst R&D organizations, potential donors and other stakeholders.
• A Capacity Development Program. Industry recognizes the serious impact of shortfalls in
health care and regulatory capacity in many developing countries and is looking at
harnessing industry and other expert resources help build capacity in affected areas.
http://www.ifpma.org/pdf/2008_01_24_Statement_to_EB.pdf
Worldwide Pharmaceutical Industry Launches Global Health Progress Initiative
International Federation of Pharmaceutical Manufacturers & Associations (Geneva)
16 April 2008
The worldwide pharmaceutical industry today launched Global Health Progress, an initiative to bring research-based biopharmaceutical companies, global health leaders and policymakers together to build on current partnerships to improve health in the developing world.
Serving as a convening point for the industry and its partners, Global Health Progress will facilitate interaction between the private sector, NGOs and governments to share research and best practices; raise awareness of global health challenges; and build partnerships to improve global health.
"Research-based biopharmaceutical companies contribute hugely to health partnerships for the developing world, through their unique expertise in R&D, regulatory affairs, manufacturing, logistics and many other fields, but we can't work alone." said Dr. Harvey Bale, Director General of IFPMA. "The Global Health Progress initiative should help to expand the range and scope of global health partnerships supported by our industry."
Global Health Progress today unveiled its web site, www.globalhealthprogress.org, which houses a database of research-based biopharmaceutical companies' global health programs, including information on more than 300 partners, 400 programs and ongoing investments of billions of dollars annually in products and man-hours. Featuring stories of health workers on the ground, the site highlights organizations and individuals who are making a difference in global health.
"Research-based biopharmaceutical companies have a longstanding commitment to improving global health – this initiative is a recognition of our unique role and desire to accelerate progress in fighting disease and strengthening health care systems in developing countries " said Billy Tauzin, President and CEO of PhRMA. "As individual companies and a united industry, we recognize that our efforts to address universal health challenges are best realized through partnerships with governments and NGOs that are dedicated to saving lives throughout the world."
Global Health Progress will leverage strengths in private industry to form new partnerships to further access to medicines; build capacity of health workers in developing nations; advocate for global action to address health challenges; and continue R&D to develop new tools to fight diseases that plague the developing world.
"Global Health Progress is a groundbreaking initiative to focus the expertise of the pharmaceutical industry to work with a diverse array of partners to create lasting, sustainable global health change," said Brian Ager, Director General of EFPIA. "We recognize that global health challenges are complex and we want contribute our experience and resources to developing new solutions."
http://www.ifpma.org/pdf/2008_04_16_Release_Global_Health_Progress_Launch.pdf
Below is the Global Health Progress website, but sadly not a single mention of Sickle Cell anywhere on their pages. The site itself is well presented and appears current, so there is hope in this significant initiative imo
http://www.globalhealthprogress.org/index.php?parent=homepage
You will want to use
info@shestco.net
the .org domain was lost last year.
Sorry, nothing new there either... eom
Thanks J, seems like a plausible scenario you have there. Perhaps the villain is both. ... certainly sloppy. Resolution should therefore be relativly straight forward imo, but seems not so, likely because of the stakes.
Well, that was just my point, how could she not determine this illegality question/answer during the conversation...
" umm... Ms. xxx these loans were not legal... She: ... well, what do you mean? Why not? He: well, they just aren't ..." just does not make sense in that type of context - at least to me.
I don't see this as an issue with the attorney, the loans weren't illegal and still aren't illegal otherwise Dr. Swift wouldn't be giving her an offer to buy them. If they are illegal, then there's a problem with the attorney and them being shopped out. If they are not, why is she being told they are? There are problems both ways here.
Obviously these incongruencies wrt the legality of the loan(s) would have/should have been addressed at the moment of the offering (of anothers' purchase for discount). I, like others, would like to know what Dr. Swift's reply is to this specifically.
Also, what is it that makes the loans illegal today and not yesterday? Your acquaintance should already have these answers I would expect, directly from Dr. Swift, no? Final Q would be - does she have a different phone number to access Dr. Swift?
Progress toward nutrition, health, education, and other development goals off track, Global Monitoring Report Finds
Press Release No. 08/75
April 8, 2008
A new World Bank-IMF report warns that most countries will fall short on the Millennium Development Goals (MDGs), a set of eight globally agreed development goals with a due date of 2015. Though much of the world is set to cut extreme poverty in half by then, prospects are gravest for the goals of reducing child and maternal mortality, with serious shortfalls also likely in primary school completion, nutrition, and sanitation goals.
( We might hope that a subsidisation program for Nicosan would become a priority here for reducing child and maternal mortality...)
"In this Year of Action on the MDGs, I am particularly concerned about the risks of failing to meet the goal of reducing hunger and malnutrition, the `forgotten MDG'," said Robert B. Zoellick, President of the World Bank. "As the report shows, reducing malnutrition has a `multiplier' effect, contributing to success in other MDGs including maternal health, infant mortality, and education."
Halfway to 2015 - Fast Facts
• Though the overall aid landscape is expanding, official development assistance (ODA) —estimated at $103.7 billion in 2007—has stalled. To meet the G8 promises to increase aid by $50 billion by 2010, ODA must expand. Meanwhile, new donors like China and India are growing in size and importance.
• Growth momentum will have to be sustained and broadened in developing countries in the face of financial turmoil. The IMF projects global GDP growth will slow from 4.9 percent in 2007 to 3.7 percent in 2008. Developing countries' growth will ease to 6.7 percent, but persistent financial market turmoil and knock-on effects on growth pose significant downside risks.
• The number of people living on under $1/day in the developing world declined by 278 million between 1990 and 2004, and a stunning 150 million in the last 5 years of that period.
• Rapid progress is possible. Vietnam reduced poverty from 58 percent in 1993 to 16 percent in 2006.
• Forty million more children are in school and gender disparity in primary and secondary schools has declined by 60 percent, but 75 million children remain out of school.
• Every year, three million more children survive, and 2 million lives are saved by immunization. But every week, 10,000 women still die from treatable complications of pregnancy and birth, and over 190,000 children under five are lost to disease. Two million people now receive AIDS treatment, but about the same number die every year of the disease, and over 33 million are infected with HIV.
• The economic burden of environmental health hazards is estimated at 1.5 to 4 percent of GDP. Worldwide, environmental risk factors play a role in 80 percent of diseases, including malaria, diarrhea, and respiratory infections. A child dies of malaria every 30 seconds.
• A billion people lack reasonable access to safe drinking water and 2.6 billion people (40 percent of the world population) do not have access to basic sanitation. Meeting the water and sanitation targets will require doubling the current annual investment to about $30 billion.
... there is more at this link
http://www.imf.org/external/np/sec/pr/2008/pr0875.htm
Our 5-HMF has a close connection to one of the most important traditional Chinese medicines Rehmanniae Radix (Di Huang).
5-Hydroxymethyl-2-furfural, a clinical trials agent for sickle cell anemia, and its mono/di-glucosides from classically processed steamed Rehmanniae Radix
Journal Journal of Natural Medicines
Publisher Springer Japan
ISSN 1340-3443 (Print) 1861-0293 (Online)
Issue Volume 62, Number 2 / April, 2008
Category Original Paper
DOI 10.1007/s11418-007-0206-z
Pages 164-167
Subject Collection Biomedical and Life Sciences
SpringerLink Date Wednesday, October 31, 2007
Abstract
Rehmanniae Radix (Di Huang) is one of the most important traditional Chinese medicines (TCM), and is used for multiple therapeutic purposes. In our investigation of the chemical constituents of Rehmanniae Radix, steamed roots were prepared by the classical processing method. Reversed-phase HPLC of the 50% MeOH extract of steamed Rehmanniae Radix yielded three 5-hydroxymethylfurfural derivatives. The new furfural disaccharide 5-(α-d-glucopyranosyl-(1→6)-α-d-glucopyranosyloxymethyl)-2-furancarboxaldehyde (1) was isolated and characterized, together with its known aglycone 5-hydroxymethyl-2-furfural (3), which is currently in sickle cell anemia Phase I clinical trials, and its corresponding monosaccharide 5-(α-d-glucopyranosyloxymethyl)-2-furancarboxaldehyde (2), which was isolated as a natural product for the first time. The presence of these three compounds, particularly 3, which were not found in the unprocessed extract of Rehmanniae Radix, could substantiate the traditional medicinal use of steamed Rehmanniae Radix.
Keywords Rehmanniae Radix - Traditional Chinese medicine (TCM) - 5-Hydroxymethylfurfural (5-HMF) - Reversed-phase HPLC
http://www.springerlink.com/content/m7g4852136j77416/
'lmf1264' ,you know what the board problem is? In large part, most of us left here have been here for years and are substantially disillusioned, considerably burnt-out, and quite tired of trying to maintain a positive view of the negative situation (wrt shareholders treatment and pps). We all put on a brave face for months/years, making the best we could of what continuously apppears to be a worsening condition.
We all know the buildings at XPNL will be completed and outfitted. We all know that 5-HMF has wild-card potential that may be realised for Xechem (sooner perhaps than later). We all know that Nicosan is the SCD treatment of choice, if not today, then in due time. What we do not know is will we, who have supported this company for years, will we be part of the company going forward? Present evidence suggests that our participation in the success of Nicosan is not a certainty, and may be tenuous at best.
We have lots of hopes, but we are tired of 'working' it. Or at least that is how I feel, so this is only my opinion. Rest assured that your presence here is most welcomed, and you are a breath of fresh air for us I think. Thing is, some of us need more than the fresh air, we need oxygen en masse lol
UNICEF Tasks FG, States on Infant Mortality
From Christopher Isiguzo in Abakaliki, 04.06.2008
To the NFG: It's time to provide Nicosan to the masses and save thousands of infant and maternal lives every year. A no brainer really, so get to it!
United Nations Children Emergency Fund (UNICEF) yesterday in Abakaliki, Ebonyi State, called on the country’s political leaders, from the federal, state to the local government levels to fashion out a policy framework aimed at reducing the increasing rate of infant and maternal mortality if it has any intention of realising the Millennium Development Goals (MDGs).
Speaking during a Zonal Network for Children organised by the UNICEF A Field Office, Enugu in collaboration with the office of the Secretary to the Ebonyi State Government for Secretaries to the Governments of ten states in the South east, South-south and North Central, the UNICEF country representative, Dr Robert Limlim stated that his agency was ready to work with third world countries in realising the goal. He noted that they equally needed the commitment of the governments of the various countries.
“How can we allow infants to die before their first birthdays? What right do we have to claim moral authority over the people we lead when we allow incessant deaths?
The various governments must show the political will to halt this situation because our report on infant and maternal mortality in this country is alarming,” he stated.
He also urged the various state houses of assembly who are yet to pass the Child Rights Bills to do so, as that would be a stepping stone to achieving success in the mortality issue, adding that by the time the bill was passed, the various rights of the child would have been guaranteed.
“We must allow our children access to basic need of life, especially to good health, basic education. It will also go a long way in curbing such unfortunate issues as child trafficking, child labour, exploitation of children. We can’t continue to stigmatize our children under any guise. Therefore time to act is now,” he noted.
On the issue of HIV/AIDS, the UNICEF country representative also urged the state and federal government to make more effort in checking further spread of the disease, noting that the fact that the issue was the number six in the eight goals contained in the MDGs made it mandatory for there to be concerted effort in that direction.
Also speaking, the Chief of A Field Office of UNICEF, Mrs. Pelucy Ntambirweki stated that the meeting was very crucial since it was the first time political leaders in the region were coming together to review “and fulfill that imperative of leadership-having the best interest of children at the heart of policies, programmes, and activities.
She therefore tasked the leaders to reflect deeply on the points that make for progress in programme delivery for children and those that have often impeded programming for children in the respective states.
In a remark before declaring the forum open, the Secretary to the Ebonyi state government, Chief Fidelis Mbam stated that the coming together of the SSGs to discuss the issues that affect children and mothers was very necessary, since as the administrative heads in their various states, they stood the better chance of informing their governments on how to key into UNICEF programmes.
He further stressed that the Ebonyi state government was deeply committed to partnering with all the development agencies in the realisation of the MDGs.
THISDAY reports that top government functionaries from Abia, Imo, Enugu ,Anambra, Bayelsa, Rivers, Cross-River, Akwa-Ibom and Benue were represented at the one day forum.
http://www.thisdayonline.com/nview.php?id=107898
Perhaps, but this placeholder has been at the front door for about two years now, so I imagine things here are stalled imo.
http://www.xetapharm.com/
It certainly explains the pps drop following his removal as CEO and the 'distancing' evidenced. Still, with rumours about 'no deal' with the suits, it would appear he remains much closer to the Company than the current management, especially wrt 'connections' and modus operandi overseas imo.
In part I imagine that Xechem divested itself of XetaPharm because it is/was one of Dr. Pandey's projects (imo)
http://www.xetapharm.com/aboutus.html
http://www.xetapharm.com/technical.html
I would presume the individual you are so very graciously assisting is aware that it could take up to six months before benefits are realized? Of course, it might not work for them at all, however this likelyhood would seem low.
Hopefully there are benefits felt in only one month and we all look forward to hearing the patient's comments in due course. Thanks for sharing the success of the purchase. With a little marketing, this entrepreneur in Nigeria could find him/herself very busy imo.
This is the only site I am aware of today where consumers can legally? purchase Nicosan...
http://buy.nicosan.googlepages.com/about
Do you not feel that it would be much better for you to share your knowledge, having just spoken with her, rather than have 30 of us call her during the next two hours? By the time the 10th caller has called her, that mood of hers may be turning into a bad day experience... imo. Those who do not believe what you can share may call anyway, but what you are doing here with this post does nothing to help this board or Xechem shareholders - imo.
This is what leads us to believe production is up...
http://investorshub.advfn.com/boards/read_msg.asp?message_id=27469209
I think this was the one...
http://investorshub.advfn.com/boards/read_msg.asp?message_id=26085685
Well now, is that not the crux of the matter with Nicosan?
unfortunately potential sales aren't nearly that valuable, unless you can actually show you can make the drug in mass quantity and sell it (distribution plans, sales force, etc.).
Perhaps he knows that we have a HOD of .0033 on 8M shares tomorrow...
Promising quest for cure
Hopkins doctors laud new method to fight sickle cell
By Stephanie Desmon | Sun reporter
March 30, 2008
Today, doctors at Johns Hopkins Hospital say that Newton is one of the first adults in the world to be cured of sickle cell disease - and the first using an experimental bone marrow transplant that could cure thousands like her who have been told they will never get better.
Word of a breakthrough gives hope to the roughly 80,000 Americans - and millions around the world - who suffer from this debilitating and usually fatal disease, which is predominant among African-Americans and Hispanics.
"It could very much open things up," said Dr. John F. Tisdale, a senior investigator at the National Heart Lung and Blood Institute. "Everyone's cautiously optimistic."
What makes the Hopkins procedure different is that it allows patients to receive bone marrow from a donor who is not an exact match - a longtime obstacle to healing large numbers of people.
...
Until now, few have been cured - and there has been little progress in developing new treatments. Only one drug has been approved for treatment of sickle cell. Painkillers and antibiotics help patients live longer, but nothing has addressed the core problem of the genetic defect.
Newton's hematologist, Dr. Robert Brodsky, and his colleagues say they hope to change that. They are trying to enroll 25 patients in a clinical trial.
Still, the procedure is not without risk. When performed on patients with leukemia and other diseases, it has a mortality rate of 16 percent.
"We may shorten people's lives, but this is their only chance for a cure," Brodsky said. "Would you offer this to every sickle cell patient? Absolutely not. But the patient who is ending up in the emergency room three and four times a month and having organ-threatening and life-threatening complications from the disease ... should be able to make that decision."
Critics say the risk associated with Hopkins' procedure is too high, even for a small trial. They say most sickle cell patients aren't likely to die immediately without a bone marrow transplant.
'It's a bad therapy, but it's all we've got'
... more ...
http://www.baltimoresun.com/news/health/bal-te.sickle30mar30,0,6112155.story
The 16-20M number worldwide is reported as being those who have SCD. The number carrying the trait is roughly 4-8x higher. The majority of those carrying SCDisease are rural and more difficult to reach with treatment. In Nigeria, it was estimated that out of the 4M afflicted only about half (2M) have crises requiring treatment and would be expected to take Nicosan - eventually. Once full production and distribution was in process, it was anticipated that it would take about 5 years to reach half of that number (1M) as actual users of Nicosan.
So, in theory, we can realistically expect 1M users of Nicosan by about 2013, implying revenue (sales) of about $250M Gross.
Presuming a 5:1 sales:pps ratio = $1.25B market cap or roughly 50cents per share. Actual pps can be anywhere from 30c to $1 (in 5yrs). IMO
That's about it! Very well said imo. Thanks! eom
I suppose too that the REGDEX would be good news in that someone has been told something and they are thus willing to infuse cash for shares ... however I know little about such things, so very much just an opinion here...
Below are past filings of REGDEX forms... seems the last one was one year ago, prior to that three in 2005...
REGDEX [html][text] 1 KB [Paper]Notice of Sale of Securities [Regulation D and Section 4(6) of the Securities Act of 1933], items 04 and 06
Acc-no: 9999999997-08-016486 (34 Act) 2008-03-25 021-91961-1N
08044662
REGDEX/A [html][text] 1 KB [Amend][Paper]Notice of Sale of Securities [Regulation D and Section 4(6) of the Securities Act of 1933], item 06
Acc-no: 9999999997-07-013376 (34 Act) 2007-03-19 021-91961-1N
07047924
REGDEX [html][text] 1 KB [Paper]Notice of Sale of Securities [Regulation D and Section 4(6) of the Securities Act of 1933], item 06
Acc-no: 9999999997-05-041760 (34 Act) 2005-10-05 021-91961-1N
05067686
REGDEX [html][text] 1 KB [Paper]Notice of Sale of Securities [Regulation D and Section 4(6) of the Securities Act of 1933], items 05 and 06
Acc-no: 9999999997-05-038462 (34 Act) 2005-09-01 021-91961-1N
05065458
REGDEX [html][text] 1 KB [Paper]Notice of Sale of Securities [Regulation D and Section 4(6) of the Securities Act of 1933], item 06
Acc-no: 9999999997-05-011440 (34 Act) 2005-03-10 021-91961-1N
05046727
REGDEX [html][text] 1 KB [Paper]Notice of Sale of Securities [Regulation D and Section 4(6) of the Securities Act of 1933], item 06
Acc-no: 9999999997-04-004698 2004-02-09 021-91961-1N
04007634
REGDEX [html][text] 1 KB [Paper]Notice of Sale of Securities [Regulation D and Section 4(6) of the Securities Act of 1933], item 06
Acc-no: 9999999997-02-034081 2002-05-24 021-91961-1N
02038884
Companies selling securities in reliance on a Regulation D exemption or a Section 4(6) exemption from the registration provisions of the '33 Act must file a Form D as notice of such a sale. The form must be filed no later than 15 days after the first sale. The exact form type is usually REGDEX, but may be a REG D-1 or similar.
say what Fox? these were during last hour of open trading, no?
way too high imo...
... being at 1.6c
Neimeth is first successful buy-out in Nigeria –Ohuabunwa
By AZOMA CHIKWE
Tuesday, July 31, 2007
There are certainly reasons for a buyout/buyup? of XeChem... maybe not by Nigeria herself, but there must be some interest from the various behemoths these days imo
President and Chief Executive Officer of Neimeth Pharmaceutical Plc, Mazi Sam Ohucbunwa, says that the past 10 years have been those of experiential learning, experimentation and masterly ownership of enterprise for the drug manufacturing giant.
Speaking at the 10th anniversary logo launch of the company, at their corporate headquarters in Ikeja, Ohuabunwa said the company has been taken through exciting stages of management practice and has forged several alliances with reputable overseas pharmaceutical companies for sole agency of their key products.
...
"While a significant number of people and organizations, which knew or interacted with us as Pfizer Products Plc, believed in our ability to manage our new enterprise successfully, some were skeptical about our capabilities. A few others opted to watch us from an aloof and convenient distance.
"These 10 past years have been those of experiential learning, experimentation and masterly ownership of enterprise for us all.
We have taken this baby of ours through exciting stages of management practice. We have been able to forge several alliances with reputable oversea pharmaceutical companies for sole agency of their key products. We have been able to establish a full-fledged research unit, which focuses on development of products and chemical for the treatment of ailments not in the purview of research units of global pharmaceutical companies.
"We are also into the development and commercialization of efforts of local medical research scientists. Our flagship product, CIKLAVIT the pioneer product for the management of sickle cell disorder is a result of this kind of local collaboration. CIKLAVIT is registered by NAFDAC, endorsed by WHO and registered in Ghana, where it is bringing succour to sicklers. During the period, we were also able to launch 16 proprietary and seven consumer drugs as well as four nutritional/well being products.
"We have a rich pipeline of products at various stages of development.
...
"Following our ambitious growth activities, we have had to raise funds from the capital market twice in the last decade, the first being a learning one. Our recent effort was quite successful and the proceeds have enabled us to improve, modernize and expand our production capabilities in line with new GMP standards. This means a higher and diverse production capacity to deliver high volumes. We have also improved on our distribution and logistics system to ensure timely coverage of the entire country to meet customer needs and demands. Our working capital has significantly improved, thus enabling us to meet our operations’ financial needs more efficiently.
"Added to these positive indicators, we have been blessed with a crop of committed, dedicated and reliable well-trained staff who have collectively kept faith with management vision, thus making Neimeth a strong going enterprise. Our staying power has remained very strong by the grace of the Almighty God.
"We have thus been able to remain fully focused on our core competence areas of drug manufacture, marketing and distribution. The challenges of manufacturing drugs in Nigeria have been quite numerous and daunting but we intend to keep going."
http://www.sunnewsonline.com/webpages/features/goodhealth/2007/july/31/goodhealth-31-07-2007-003.htm
Wow! We've had many posts that included these two Ministers...
... this is some serious houscleaning going on... the pending of which may also be part of the delay we seem to have experienced in XPNL operations imo
Last Updated: Mar 25th, 2008 - 17:29:52
President Yar’Adua accepts resignations of Ministers of Health
Mar 25, 2008, 17:17
President Umaru Musa Yar’Adua on Tuesday March 25 accepted the voluntary resignations of the Minister of Health, Prof. Adenike Grange and the Minister of State (Health), Arc. Gabriel Aduku.
Both ministers are leaving the Federal Executive Council following charges of corruption brought against them by the Economic and Financial Crimes Commission (EFCC).
It is expected that without the burden of their ministerial duties, they will be better placed to respond to the charges against them.
In a statement signed by the Special Adviser to President Yar’Adua on Communications, Mr Olusegun Adeniyi, the President has also ordered the Head of the Civil Service of the Federation, Engr. Ebele Okeke to direct that the Permanent Secretary in the Federal Ministry of Health, Prof. Simon Ogamdi, the Director of Administration, Dr. H.B. Oyedepo and the Director of Finance, Hanafi Muhammed who participated in the subversion of his directive on the return of unspent Budget 2007 funds to the Treasury should proceed on immediate suspension in accordance with extant civil service rules pending further disciplinary action by Government.
Another Director, Mr. M.S. Hamid, a Chief Accountant, Abdulrahaman Ambali, a Principal Administrative Officer, Mr. Donald Ekanem, a Principal Transport Officer, Mr. Donatus Iyang and seven other civil servants in the Ministry were also affected by the suspension order.
The Minister of Labour, Dr. Hassan Muhammad Lawal is to oversee the affairs of the Federal Ministry of Health until further notice.
http://www.nigeriafirst.org/article_8120.shtml
State may lose race for sickle cell cure
Raven, U ROCK GIRL !!!
March 25, 2008
State may lose race for sickle cell cure
By Rick Harmon
rharmon@gannett.com
Researchers at the University of Alabama Birmingham believe they can cure sickle cell disease in the next five years -- or they did before they saw proposed across-the-board budget cuts for higher education.
Cutting budgets for state research universities will mean fewer dollars, a loss of discoveries and in the case of a medical research facility such as UAB, the loss of lives, said university officials.
UAB researchers created a gene replacement process that has cured sickle cell disease in mice, which have similar physiology to humans. But to show that the cure will work safely in humans will require massive testing, a top facility, and the retention and recruitment of some of the best minds in the field.
It will take money.
Richard Marchase, UAB's vice president for research and economic development, fears a funding drop.
"A cure that is five years out might become a cure that is seven or eight or 10 years out," he said.
And when that cure comes, it might come from somewhere else.
"We are clearly in the lead right now, but there are other institutions and other countries that are putting much more money into these types of strategies than we are, and a further cut in our research capacity could very easily mean that the place that does this first could easily be a place other than Alabama," he said.
Tim Townes has been searching for that cure at UAB for 24 years. He wants his team, UAB and Alabama to come up with the cure before "the Japanese, the Chinese, the French or the British, and on a national level, the Harvards and the Stanfords."
"We want to win this race," said Townes, chairman and professor of biochemistry and molecular genetics at UAB. "We want to be the first to cure sickle cell disease and we want to do it here in Alabama, where we believe at UAB we can go from initial discover all the way to treatment of patients, all at one place."
But despite his competitive spirit, he and the other scientists working on the project clearly realize how secondary winning that race is.
"I was just out talking to a group about what we are doing and met a mother whose child had died from sickle cell disease. Then I talked to a father with two children who had the disease," he said. "That's the motivation. Yes, we want to be the first to find the cure, but most important is that there is a cure."
More than 70,000 people in the United States have the disease that affects their red blood cells, and about 1,000 babies are born with it each year, according to the U.S. Centers for Disease Control and Prevention.
About one in 500 African Americans has the disease.
Besides the human suffering the disease has a significant economic impact. A study showed that between 1989 and 1993, it resulted in about 75,000 hospitalizations and almost half a billion dollars in health costs in the U.S., according to the CDC.
UAB may direct its limited funding to the cure for sickle cell disease, but if it does, other cures could be lost or delayed.
What are they?
"We could make a very long list for you," Marchase said.
He said UAB is making advances in Parkinson's disease and Alzheimer's that could bring about results just as spectacular as those with sickle cell disease.
They are researching why Southerners, particularly blacks, have more strokes than the rest of the country.
They are creating a new cancer compound in partnership with the Japanese company Sankyo that will bring a stream of income to the university for the foreseeable future based on sales.
The fruit of the research can mean an increase in income for the university.
"This past week we found out that we will be one of eight diabetes centers funded by the federal government," Marchase said, adding that this is one more reason why talk of huge budget cuts to higher education perplexes him.
The research institutions can leverage state funds into more money for the state.
For the diabetes center, UAB needed to pledge around $330,000, for which it needed state funding. But those funds will result in about $6.4 million returning to the university for the diabetes center.
"Most of our grants are about 50 percent for salary for workers and faculty and 50 percent for supplies, equipment and other things," he said. "So that means that the investment will result in about $3.2 million in jobs."
Townes said he isn't an economist and doesn't know how much money the science he practices creates. But he does know something about big business: It likes good universities.
"When big businesses are recruited here, the quality of the state's universities is one of the things used to recruit them, especially research universities like UAB," he said.
_______________________________________________________
Reader Comment Sun Mar 23, 2008 3:51 pm
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
Reader Comment Sun Mar 23, 2008 3:50 pm
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.
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..
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
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
http://www.montgomeryadvertiser.com/apps/pbcs.dll/article?AID=/20080323/NEWS/803230310/1001
NHLBI Announcement: Institute to Realign its Sickle Cell Disease Research Program
For Immediate Release
March 10, 2008
8:00 AM
The National Heart, Lung, and Blood Institute (NHLBI) announced today a comprehensive and innovative restructuring of its research program in sickle cell disease (SCD).SCD is a serious inherited blood disorder that most commonly affects people with origins in Africa, Latin America, the Middle East, or the Mediterranean.Since 1972, the NHLBI has developed and maintained a major research effort to improve the lives of individuals with SCD.The studies have led to a number of effective approaches for the management and treatment of the disease, and today’s patients live longer and have a better quality of life than was the case in previous generations.However, there is no cure for SCD, and therapies that exist do not benefit all patients.
The recent issuance of the Institute’s Strategic Plan (http://apps.nhlbi.nih.gov/strategicplan/) and the scheduled renewal of the Comprehensive Sickle Cell Centers (CSCC) program provided an opportune time to rigorously assess the NHLBI program in SCD.The National Heart, Lung, and Blood Advisory Council conducted an extensive review of the Institute’s research and training portfolio in SCD, taking into account responses received to a public solicitation for input from patients and lay and professional constituencies about the top scientific and clinical priorities.A detailed report on the Council’s findings and deliberations can be found at http://www.nhlbi.nih.gov/resources/docs/scd_program.htm. Recommendations include the following.
Basic science — Research should focus on disease mechanisms; new treatment approaches; genes and genetics; molecular biology and biomarkers; vascular biology; erythropoiesis and red blood cell biology; and animal models.Progress in this area will require stimulation of investigator-initiated research applications, with careful attention to appropriate peer review, and expanded involvement of scientists from areas other than hematology.
Translational and clinical research — Emphasis should be placed on pain pathophysiology and management; fetal hemoglobin induction; trials of promising alternatives to hydroxyurea; approaches targeting disease pathophysiology; curative therapies; and prediction, prevention, and management of severe manifestations and end-organ damage.The NHLBI should provide research resources such as databases for genotype–phenotype data and repositories for biological samples, encourage resource-sharing among investigators, and assist investigators in bringing clinically relevant basic science discoveries to the point where they are ready for human trials.
Participation in clinical research — The Institute should increase the pool of potential participants for interventional and observational studies and to provide opportunities for geographically broad participation by individuals and investigators in research.
Translation and dissemination to the community — Timely and thorough application of research findings should be promoted through development of evidence-based practice guidelines and their widespread dissemination via educational programs for physicians, other health-care providers, and patients.
Based on the NHLBAC recommendations, the NHLBI is moving forward with the following innovations to its SCD portfolio.
Support for basic research will be expanded through funding of investigator-initiated grant applications and through NHLBI-initiated RFAs (requests for applications) focused on the pathophysiology of SCD, the biology of pain in SCD, fetal hemoglobin switching, and genetic modifiers of disease expression and progression.
The Institute will reconfigure the CSCC program into a Basic and Translational Research Program by funding meritorious projects submitted in response to the recent RFA (http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-06-008.html). The program will emphasize fundamental investigations and their translation into initial studies in humans, as well as community translation to promote evidence-based clinical practice. SCD Scholars programs for the career development of young investigators and Summer-for-Sickle-Cell-Science programs for research training and mentoring of high-school students also will be supported as part of a larger effort by the Institute to prepare the next generation of scientists to advance the field of SCD research.
The NHLBI has requested comments from its constituency regarding interest in joining the RAID (Rapid Access to Interventional Development) program of the National Cancer Institute, which provides contract services to aid in the translation to the clinic of potential new therapeutic agents originating in academia (http://grants.nih.gov/grants/guide/notice-files/NOT-HL-08-111.htm). The RAID offers an avenue for swift progress in evaluation of promising therapeutic approaches such as innovative drugs to stimulate fetal hemoglobin production.
The NHLBI will develop a new Clinical Trials Research Network (CTRN) designed to open participation in clinical research to a much larger number of investigators and individuals with SCD than is currently possible. Structured similarly to the Children’s Oncology Group (http://www.childrensoncologygroup.org/, which offers clinical trial participation to all eligible subjects and investigators, the CTRN will, in time, subsume the current SCD Clinical Research Network (http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-05-006.html).
The NHLBI will expand its support of genomic research in SCD beyond the boundaries of current efforts being conducted within the framework of the CSCCs (http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-05-006.html) by developing a program like the Framingham SHARe (SNP Health Association Resource— http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000007.v2.p1) with contributions of genotypic and phenotypic data from many investigators and their patients and free access to qualified researchers.
Finally, the Institute will undertake a focused effort to develop evidence-based guidelines for the care of individuals with SCD across the life-span that can be used by health-care practitioners throughout the world. An educational campaign will be launched, in partnership with the Sickle Cell Disease Association of America and other patient advocacy groups and professional organizations, to raise awareness about SCD and bring nationwide attention to its diagnosis and treatment.
By implementing these recommendations, the NHLBI intends to take advantage of existing scientific opportunities and make SCD resources more widely available, better serving both the SCD research and the patient communities.
Inquiries may be directed to:
Susan B. Shurin, M.D.
Deputy Director
National Heart, Lung, and Blood Institute
Building 31, Room 5A48
9000 Rockville Pike
Bethesda, MD 20892- 2486
Telephone: (301) 496-1078
Fax: (301) 402-0818
Email: Shurinsb@nhlbi.nih.gov
http://public.nhlbi.nih.gov/newsroom/home/GetPressRelease.aspx?id=2556
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As an aside, the NHLBI is likely aware of both Nicosan and 5-hmf from a presentation by Pandey in Nov 2006:
PRESENTATIONS
The first presenter was Dr. Ramesh Pandey from Xechem Co. . Support personnel included Dr. Renuka Misra, Dr. Peter Gillette, and Dr. Don Abraham. Dr. Pandey presented new information on two anti-sickling drugs that have great potential, NICOSAN and 5-HMF (5-hydroxy methyl-2-furfural). 5-HMF is a water-soluble aldehyde that is easily absorbed, slowly metabolized and free of any significant side effects. It is a strong anti-sickling agent by virtue of its ability to shift the oxygen saturation curve of hemoglobin to the left, thereby making it more difficult to polymerize. In the sickle mouse model, 5-HMF significantly extends the survival time following episodes of hypoxia. Concentrations up to 3 mM effecting 95% of the available hemoglobin have been obtained. NICOSAN is an herbal extract from four separate plants. In addition to its anti-hemoglobin S polymerization properties it acts to hydrate the cells. This counteracts the dehydration of cells that often occurs during reversible sickling. Dehydration concentrates the hemoglobin and makes it more susceptible to polymerization.
http://www.nhlbi.nih.gov/meetings/scd/2006-11minutes.htm