The Sickle Cell Cure Foundation Inc.

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About SCCF

SCCF Purpose

Global Mission

MALARIA & SCD

CORPORATE DONORS

SCCF’S GLOBAL MISSION: “Pro Humanitate”*

Sickle cell disease (SCD) is a global problem. As the most common genetic disease in the world, SCD touches the lives of millions and affects many more. People of at least five racial groups and numerous ethnic origins have inherited the sickle gene. SCD is correctly classified as a “tropical disease”, since it is most common among populations living close to the equator, in tropical and subtropical regions. The populations in which SCD occurs most frequently live in Africa (which has about 75% of the cases), in Mediterranean countries, in the Middle East, and in India, with significant numbers in the Caribbean, Brazil, and Oceania. Migrations of people from these regions have resulted in significant numbers of SCD suffers in North America, South America, and Europe. The prevalence and continued high incidence of sickle cell is due in large part to resistance to the chronic effects of malaria that is conferred by the presence of sickle hemoglobin in the red blood cells of carriers, as well as SCD patients fortunate enough to survive childhood. However, this benefit of the sickle trait comes at a very high cost to those who inherit two copies of the sickle gene. SCD is a terrible disease that brings with it pain that is frequent and often severe, life-threatening organ damage, and limitations to the daily lives of the sufferers and their families. In developing countries short on comprehensive medical care, SCD is a death sentence that terminates life early, often within the first two years.

SCCF has a cure that prevents manifestations of the bodily damage which results from SCD! Our cure is the product of 33 years of research funded by NIH and other non-profit foundations. This cure is truly unique, very stable, easy to deliver, and has very low likelihood of side effects. The effectiveness has been proven in more than 50 types of laboratory experiments, each repeated multiple times by different investigators.

The SCCF is committed to alleviating this terrible disease in as many suffers as can be reached. To this end, the SCCF has a global plan for distribution of the cure at a cost that 80% of the SCD sufferers in the world can afford. Our plan combines safety and clinical trials with a cost-effective business plan that includes a “north-south” dialogue and “west-east” cross subsidies from advanced economies to economically less affluent regions in such a way that all people may receive the “cure” at a cost much lower than what they now incur for inferior, much less effective treatments. This global plan has SCCF partnering with other charities to create teams with the management skills, medical knowledge, multi-cultural experience, timely funding, and – above all -- passionate commitment, as well as the experience on the ground to deliver this long-awaited cure to humanity. How Oklahoma came to be the discovery location for a tropical disease is a story in its own right composed of new facts, sound growth policies, and the occasional stroke of genius. Oklahoma’s pro-business policies certainly favor economic development of the bio-medical sector. Insights into evolutionary and developmental biology influenced how to structure the “search”. Discoveries in basic science rarely unfold on schedule, within budget, with no detours. In a field as creative as biomedical research, there will always be the “unknown” where insight and intuition merge.

* “Pro Humanitate” is the motto of Wake Forest University, North Carolina USA, the alma mater of Dr. Robert H. Broyles, discoverer of the cure.

HbF is a Possible Deterrent to Malaria

HbF (fetal hemoglobin) suppresses the expression of sickle cell disease. In addition, a recent literature review by the imminent Dr. David Weatherall suggests that HbF protects infants from malaria during the first year of life,until HbF levels decline to modest levels through a normal developmental transition as quoted below:

In vitro studies have shown that β-thalassaemic red cells are invaded at the same rate as normal red cells and that the rate of parasite growth is also indistinguishable from normal. However, both in human red cells and in transgenic mice carrying human γ-genes, it has been found that those which contain human fetal Hb are associated with ineffective development of P. falciparum or P. yoelli (Pasvol et al, 1977; Shear et al, 1998). As there is strong evidence that the rate of decline of fetal Hb after birth is delayed in β-thalassaemia heterozygotes (Weatherall & Clegg, 2001a), this could provide a mechanism of protection during the first year of life, but no longer; the studies of Passvol et al (1977) suggested that retardation of parasite growth required 5-7 pg/Hb F per cell.Source: Weatherall, David J. (Professor Sir). “Genetic Variation and Susceptibility to Infection: the Red Cell and Malaria” British Journal of Haematology. Vol. 141, 2008. p. 280.

Indeed! If one were to revive and sustain the body’s production of HbF --- the infantile “mechanism of protection” (HbF) of which Dr. Weatherall speaks so eloquently -- then one would have discovered by association not only a cure for SCD but also a novel, genetically based approach to the control and management of malaria. Such a discovery would be on a totally different order of magnitude. To wit, some 370 million new cases of malaria occur each year – over a thousand times the incidence of new SCD cases. WHO and the CDC estimate global malaria mortality to be 800,000 with 90% of the victims children below the age of 5.

In 2006 Dr. Broyles demonstrated how to activate and sustain the HbF “trigger” – a discovery which forms the operational basis for the SCCF project. SCCF is in possession of a discovery that provides a phenotypic “cure” for SCD and may also confer a resistance to malaria!

Sickle Cell: A Global Disease, and a Global Plan with a Cure

Tuesday, 05 August 2008

The map below shows the global distribution of hemoglobin diseases (sickle cell and beta-thalassemia) in terms of number of sickle cell infants per 1,000 births. Each year, 340,000 infants die of sickle cell disease-related causes.

This figure is from the World Health Organization online document "Genes and human disease," at http://www.who.int/genomics/public/Maphaemoglobin.pdf

and is used with permission of WHO.

Executive Summaries (outlines) of "more than non-profit," "non-lucratif et encore (French)," and "beyond for-profit only" versions of our Business Plans may be viewed below.

"More Than Non-Profit"

EXECUTIVE SUMMARY

S I C K L E C E L L C U R E

Foundation Overview, Disease Burden, and Management Style

The Sickle Cell Cure Foundation, Inc. (SCCF) is a new 501c3 biomedical research firm located in Oklahoma City, USA. Under the leadership of Dr. Robert H. Broyles, SCCF has discovered and patented a cure for sickle cell disease (SCD), humanity’s oldest and most frequent genetic disorder. The cure tentatively branded DREPAC© (FTH-GRT, scientific designation) treats the cause instead of the symptoms. The name DREPAC is derived from drépanocesse, a combination of the ancient Greek drépano meaning pruning hook or scythe and the French cesser meaning to stop.

This year some 340,300 children will be born with SCD. Most will die before their first birthday. Today over 107,000 patients are receiving conventional SCD treatment primarily in Europe and North America averaging $14,443/year only to die an early death at age 42-45. Peer reviews of Dr. Broyles’ cure have brought acclaim to SCCF for its non-invasive, non-surgical breakthrough. It has no observed side effects, is 100% effective, and costs 4% the price of today’s comprehensive care. Presentations to the world’s scientific community are noted below.

SCCF’s co-op management style dubbed “more-than-non-profit” has five goals: (1) market drugs worldwide at affordable prices reducing prices as soon as feasible; (2) maximize distribution first and profits second; (3) share independent research as a north-south norm; (4) educate the public; and (5) grow the SCCF asset base. These “more-than-non-profit” goals reflect our belief that basic health care is an obligation and a right – not an option or a privilege. Numerous patents have already been issued.

Solicitation for Funds and Search for Management Partners

SCCF seeks grant funding to finance safety and Trial II activities leading up to field activities under Trial III. Recognizing SCCF’s newness to the world of drug development, we are searching for seasoned fellow charities at home and abroad to raise $5.30 million to bring the cure up to Phase III within four years. SCCF would offer a portion of royalties to compensate cooperating partners for their upfront financial and managerial assistance in this venture. Competitively procured and negotiated pharmaceutical license holder(s) would conduct Phase III trials. As patent holder and SCCF founder, Dr. Broyles intends to extend licensing and distribution rights consistent with guidance from the World Intellectual Property Organization. SCCF would consider awarding partner charities with reciprocal board memberships and/or a stream of royalty payments as negotiated among licensee(s), patent holders, non-governmental
organizations, and participating charities both local and expatriate.

We expect to eliminate 58% of the expression of SCD by 2016 and 87% by 2028.

FTH-GRT (DREPAC©) and Technology

The product is ferritin-heavy chain (FtH), a protein that occurs naturally in the body. It has been shown to deactivate the sickle cell gene and to reactivate a dormant, healthy replacement gene. Yet, FtH does not permanently alter the genes. The cure addresses the embedded genetic cause of SCD – not its external symptoms. The cure is specific to the ailment and easy to administer. Quite stable, FtH requires no refrigeration making it easier to market and distribute in tropical, developing countries where over 90% of SCD sufferers reside. The drug’s detailed identification, its modes of application, and salutary effects are unique, proprietary, and patent-protected.

Of course, the biggest barriers to marketing are time-consuming regulatory hurdles: continued patent applications, safety trials, clinical trials here and abroad, and approval from regulatory bodies such as the U.S. Food & Drug Administration (FDA) or the European Medicines Agency (EMEA).

Anticipated Benefits of the “Cure” for SCD Sufferers

+ 100% medical efficacy + No side effects + No high risk surgery or chemo

+ up to 340,300 infants saved each year (2008 estimate)

+ 4% cost of current care + 107,000 current SCD patients each save $13,865/year

+ Sufferers can look forward to a full lifespan (age 82) instead of dying about age 45

SCCF Management Team
Robert H. Broyles, PhD – President and Founder of SCCF, Professor of Biochemistry & Molecular Biology, specialized in molecular biology and developmental biology, discoverer of the SCD cure. Strengths: comprehensive scientific analysis, able to identify multi-talented teams, biomedical grant management. B.S. chemistry and PhD bio-chemistry Wake Forest University, National Institute of Health fellowship/grants. Community service: American Red Cross, Boy Scouts, First Unitarian Church.

Gary W. Bricker, CFP- Program Director (designate) of SCCF. B.A. economics University of Connecticut, M.S. urban planning (Third World) Columbia University. 25 years in developing country economic planning, specialized in sub-Saharan Africa grants/loans in public health sector. Strengths: overseas financial planning, technical contract and charity management. Community service: United Nations intern (New York), Habitat for Humanity, School without Boundaries, primary school creation, Black Sea University lecturer, First Unitarian Church. Work/study: Zambia, Somalia, Ghana, Burkina Faso.

To Be Identified - Chief Financial Officer of SCCF. 5+ years experience in finance, fund-raising, investment syndication, project incubator skills, 501c3 advice, corporation tax, legal requirements and filings. Strengths: objective personnel assessments, leadership skills, team builder advice, mentoring others in bookkeeping. CPA and/or MBA. Resident in Oklahoma City. Community service: TBD.

Market Opportunity

Market size historically small due to estimated 75% infantile and child mortality. With the cure tentatively branded as DREPAC © (FTH-GRT), the SCD survivor community could grow by as much as 340,300 per year. Few viable competitors. Product free to assume major market niche limited only by logistics and distribution barriers in remote rural areas, presuming cross-subsidization pricing is effective.

Funds Sought, Financial Projections, and Exit Strategy

Seeking $5.259 million in grants/concessional rate loans over five years ($1.188 million in 2008; $1.152 million in 2009; $1.496 million in 2010; $1.330 million in 2011; $0.093 million in 2012). Option “A” -- NGOs, parastatals, and/or governments would contract with one another for these final field testing services as appropriate. Option “B” – One or more licensed pharmaceutical companies will fund and conduct Phase III trials costing approximately $12.0 million and begin marketing 12 months later.

Participating NGOs and/or parastatals may continue as a consortium after patents have expired. Since coops do not issue voting stock, there is no risk of an unfriendly stockholder take-over. Many coops thrive beyond the death of their founding members. There is no mandatory “exit”.

Hypothetical financial example for the Year 2019:
pharmaceutical licensee(s) projected to gross $214 million, while a 7.5% royalty stream of $16.0 million will compensate partnering charities, pay management employees, fund more research, and expand charity’s asset base until license expires in 2028. The annual “surplus” of $26 million would be shared among partnering groups and employees.

Example continued with SCCF as patent holder under USG charity rules:

144.5% -Internal Rate of Return (2008-2028)

$396 million --Net Present Value at an 18% discount (2008-2028)

1X Break-even of $17.259 million ----------- 1year 4 months

2X Break-even of $34.518 million ---------- 2 years 1 month

5X Break-even of $86.259 million --------- 4 years 9 months

Contact: Robert H. Broyles (405) 706-5802 This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
www.sicklecellcurefoundation.org

CVs for Dr. Broyles and Mr. Bricker available upon request.

"Non-Lucratif et Encore"

PRECIS DESTINE AU CONSEIL D’ADMINISTRATION

La Fondation du Guérison Drépanocytaire (FGD)

La Découverte, l’Etendue de la Maladie, la Confirmation Continue, et Notre de Gestion

La Fondation de Guérison Drépanocytaire (la FGD) est une société à but non-lucratif récemment établie et dédiée à la recherche biomédicale. Sous la direction du docteur Robert Broyles, la FGD a découvert la voie d’une guérison drépanocytaire pour laquelle l’Union Européenne lui a accordé un brevet afin de combattre cette maladie génétique – la maladie la plus fréquemment documentée et la plus vieille de toute l’histoire humaine. La guérison porte DREPAC © (FTH-GRT, désignation scientifique) comme nom de marque provisoire et trait les causes profondes de la maladie au lieu de ses symptômes externes. La gènese du nom DREREPAC provient du grec ancien drépano qui veut dire faucille et du mot cesser en français.

Cette année environs 340.300 enfants seront nés avec la drépanocytose. Malheureusement la plupart sera morte avant leur premier anniversaire. Aujourd’hui 107.000 patients reçoivent le traitement anti-drépanocytaire standard à un coût moyen de €9.029 ($US 14,447) par an. En dépit de ces dépenses extraordinaires, ces
victimes parmi les mieux soignés du monde ne cessent pas de mourir assez jeunes entre l’âge de 42 et 45 ans à la moyenne.

Les études analytiques et les recherches indépendantes suite aux présentations rendues par le docteur Broyles au cours des colloques de savants n’ont fait que
confirmer la découverte. Ces examens aux laboratoires par collègues et par inconnus ont fait accroître la renommé de la FGD puisque le nouveau protocole n’a pas besoin d’intervention chirurgicale ni de visites fréquentes à l’hôpital.

Il n’y a pas d’effets secondaires reconnus. Le remède est efficace à 100%, et ne coute que 4% du prix typique des soins compréhensifs. Prière de consulter la liste des
présentations offertes par le docteur lors des colloques annuels de savants et de chercheurs.

La FGD se sert d’un style de gestion dit “non-lucratif et encore”. Il comporte cinq éléments dont quelques uns cherchent un bénéfice tandis que les autres poursuivent un but social:

1. Vendre la guérison aux prix à la portée du monde entier en essayant de la vendre aux prix mêmes plus réduits aussitôt que possible.

2. Au début de la campagne de vente, agrandir le réseau de distribution même s’il faut réduire la marge de bénéfice.

3. Partager les fruits de recherche indépendante autant qu’un dialogue normatif qui renforce les rapports Nord-Sud.

4. Renseigner le public (du village jusqu’à l’université) au sujet de la guérison drépanocytaire, y compris son dépistage.

5. Faire accroître les fonds de recherche disponibles à la FGD, y compris le nombre des échanges entre instituts et leur personnel.

Ces « buts non-lucratif et encore » rappellent notre croyance que l’accès aux soins médicaux doit être un devoir et un droit. En plus, cet accès ne doit pas être facultatif mais obligatoire pour tous – non seulement les privilégiés.

Plusieurs brevets ont été déjà accordés.

Demande des Fonds et la Recherche d’un Directeur de Gestion

La FGD sollicite des dons pour financer les essais de sureté jusqu’aux essais de l’Etape No. II qui amènent au chantier d’essais de l’Etape No. III. En se rendant compte que la FGD vient d’arriver au monde du développement de produits pharmaceutiques neufs, nous cherchons d’autres sociétés pareilles à but non-lucratif qui sont déjà rodées pour travailler avec nous en partenariat dont le siège social pourrait être domestique ou étranger. Le budget estimatif à travers ces années d’essais (2008-2012) est de l’ordre de €3.313 millions ($US 5.293 million) -- fonds suffisants pour nous amener au seuil de l’Etape No. III.

A ce point, la FGD – toujours en partenariat -- se propose solliciter parmi les sociétés pharmaceutiques celles qui voudraient financer et diriger toute l’Etape No. III en
échange du droit exclusif de recevoir le transfert de brevet, en particulier les droits de commercialisation et du marketing. La sollicitation suivra les protocoles compétitifs d’acquisition internationale conformes aux principes internationaux prônés par l’Organisation Mondiale de la Propriété Intellectuelle. La société la plus compétitive payera des rentes à la FGD, qui à son tour payera un pourcentage de ses rentes à tous les collègues qui auront participé dans cette aventure selon la durée et le niveau de chaque effort individuel.

Nous nous attendons éliminer 58% de l’expression drépanocytaire avant l’an 2016 et 87% avant 2028.

DREPAC © et la Technologie

Le remède (dont le nom commercial sera DREPAC ©) est lié à la féretine à la lourde chaine (FtH), une protéine que le corps produit naturellement.   On a déjà montré que la
FtH peut dé-activer le gène drépanocytaire muté et simultanément réveiller le gène sain qui le remplace. Néanmoins, FtH ne change pas les gènes pour toujours.   La guérison s’adresse aux causes profondes de la drépanocytose au lieu des symptômes externes.
La guérison est spécifique à la maladie. Son administration est facile.    Le produit est si stable du point de vue chimique qu’il n’est pas nécessaire le mettre au frais, une situation favorable pour marchander et distribuer ce remède salutaire dans les pays
tropiques en voie de développement où habitent plus de 90% des victimes drépanocytaires. La composition moléculaire du produit pharmaceutique, ses effets
salutaires, et ses modes de traitement sont reconnus autant que de la propriété intellectuelle déjà protégée par des brevets.

Certes, la barrière la plus prolongée est l’approbation du permis de vente de la part des autorités régulatrices telles que le European Medications Agency (EMEA) ou le U.S. Food and Drug Administration (USFDA).

Les Bienfaits Attendus pour Ceux qui Souffrent de la Drépanocytose et Qui Suivent un Traitement DREPAC©
• Efficacité médicale à 100%
• Aucun effet secondaire
• On peut éviter les risques importants liés aux interventions chirurgicales et aux thérapies chimiques
• 340.300 enfants sauvés chaque année (l’an 2008 estimatif)
• Le coût projeté du traitement DREPAC © ne sera que 4% des tarifs actuels
• Environs 107.000 patients pourront épargner €8.888 ($US 13,865) par an
• Les victimes drépanocitaires pourront s’attendre à une durée de vie normale de 82 ans au lieu de mourir à l’âge de 45 ans

L’Equipe de Gestion FGD

Robert Broyles, docteur – Président-Directeur Général (PDG) et Fondateur de la FGD, professeur en biochimie et biologie moléculaire. Spécialiste en biologie moléculaire et la biologie du radical libre, il a découvert la guérison pour la drépanocytose. Points forts: analyse compréhensif et scientifique, peut identifier des membres des équipes doués de talents multiples, gestion des dons de recherche. License ès science en chimie et doctorat en biochimie – Wake Forest University. Chercheur et savant au National Institute of Health. Activités communautaires : la Croix Rouge Américaine, Boy Scouts, First Unitarian Church.

Gary Bricker, Certified Financial Planner - Directeur du Développement (nommé) pour la FGD. License ès lettres en science économique University of Connecticut,
Maîtrise ès sciences en urbanisme (option Tiers Monde) Columbia University. 25 ans en planification économique dans les pays en voie de développement. Spécialiste
dans la gestion des dons et des prêts du secteur santé publique des pays au sud de Sahara. Points forts: planification financière d’outre-mer, la gestion technique des contrats et des dons. Activités communautaires : l’internat auprès de l’Habitat pour l’Humanité (Nations Unies) New York, conseiller – Schools without Boundaries, démarrages d’écoles primaires, professeur adjoint – Black Sea University (Tblisi), First Unitarian Church – conseil d’administration. Lieux de travail/d’études : la Zambie, la Somalie, le Ghana, le Burkina Faso.

Directeur des Finances, à recruter. Au moins cinq ans d’expérience dans les finances, la collecte des fonds caritatifs, l’organisation du placement des investissements, du talent dans le démarrage de projets, dans le conseil fiscal pour les sociétés à but non-lucratif, dans les impôts pour sociétés anonymes, preuves égales et leur documentation. Points forts : évaluation du personnel, conseils sur le renforcement d’équipe, programme de formation en comptabilité. Maîtrise de gestion ou expert-comptable. Habitant d‘Oklahoma City, USA. Activités communautaires- à voir.

L’Opportunité du Marché

A travers les années la taille de ce marché restait petite à cause du taux de mortalité a l’ordre de 75% pour les nouveaux nés et les enfants moins de cinq ans.

DREPAC ©, le nom de marque provisoire, sera réservé pour toute publicité au sujet du remède.

La population des survivants drépanocytaires pourrait atteindre un débit de croissance de 340.300 par an. Quant aux compétiteurs, il n’y a que très peu qui soient prêts. Le nouveau remède est bien placé pour contrôler une grande partie du marché. Si on réussit à établir une péréquation de prix parmi les marchés variés, la taille de ce marché sera limitée par deux facteurs seulement : 1) une infrastructure logistique et des barrières de transport qui empêchent une bonne distribution dans les endroits ruraux lointains et 2) le manque d’un programme national de dépistage.

Les Fonds Sollicités, les Chiffres Budgétaires, et Comment Sortir du Marché:

Nous cherchons €3.371 millions ($5.259 million) sous forme de dons ou de prêts aux taux d’intérêt subventionné sur cinq ans : 2008 – €0,762 millions ($1.188 million) ; 2009 - €0,738 millions ($1.152 million) ; 2010 - €0,959 millions ($1.496 million) ; 2011 - €0,853 millions ($1.330 million) ; et l’an 2012 - €0,060 millions ($0.093 million).

Option A - travaillant comme membre d’un consortium la FGD signera avec les organisations non-gouvernementales, les sociétés para-étatiques, et/ou les gouvernements concernés autant que sociétés à but non-lucratif un contrat pour les services d’essais définitifs rendus au chantier comme Etape No. III. Le consortium
lancera une Demande de Propositions de Projet à cet effet.

Option B – A la suite d’une compétition technique et financière, la FGD attribuera un transfert de son brevet pourvu que la société pharmaceutique la mieux placée, à ses propres frais internes, finance et conduise les essais de l’Etape No. III, et commence la vente du produit au plus tard 12 mois après les approbations des autorités régulatrices.

Les participants dans le consortium (Option A) ou la société pharmaceutique (Option B) pourront continuer leur entreprise après la date terminale du brevet. En plus, il vaut bien remarquer qu’un consortium n’émet pas d’actions, et ainsi ne court pas de risque d’une reprise inamicale de la part des actionnaires. Beaucoup de consortium ou de sociétés à but non lucratif fleurissent longtemps après la mort de leurs fondateurs. Il n’y a pas de sortie obligatoire.

Exemple d’un scénario financier : Pour l’an 2019 l’entreprise pharmaceutique projette des revenus de $214 million ; la même année l’entreprise payera des rentes de 7,5% pour couvrir les dons secondaires et les dépenses suivantes : du soutien aux partenaires bénévoles, les frais de l’équipe de gestion ; une hausse dans les frais de
recherches ; l’élargissement de la base financière de la FGD jusqu'à ce que le brevet se termine en 2028. A la moyenne, un surplus annuel valorisé à $US 16 millions sera partagé parmi les membres du partenariat.

Exemple continu en chiffre avec la FGD comme détenteur du brevet (l’an 2018):

144,5% --------- taux de rentabilité interne (2008-2028)

€253,8 millions ($US396 millions) ------ valeur actuelle nette liée à un coéfficient de 75% don et 25% prêt à un taux d’escompte de 18%

1X – seuil de rentabilité ($US 17.259 million) ------ 1an 4 mois
2X - seuil de rentabilité ($US 34.518 million) ----2 ans 1 mois
5X - seuil de rentabilité ($US 86.259 million) --- 4 ans 9 mois

Contacter : Robert Broyles

011 (405) 706-5802
This e-mail address is being protected from spam bots, you need JavaScript enabled to view it www.sicklecellcurefoundation.org
Les curricula vitae de Messieurs Broyles et Bricker disponibles sur demande.

"Beyond For-Profit Only"

Combined Business Plan

Gene Regulation Therapy-Sickle Cell, Inc.

(GRT-SC)

and

The Sickle Cell Cure Foundation, Inc. (SCCF)

Executive Summary

IN A NUTSHELL

Last year an estimated 340,300 infants were born with sickle cell disease (SCD) – mankind’s most commonly inherited health disorder. Ninety-five per cent of these neonates reside in the tropical malaria “belt” and the eastern Mediter-ranean. Most will die by age five. The current “gold” standard of treatment can indeed extend the lives of SCD victims to 40-45, but their families must be able to pay for lifelong sophisticated
care only available in advanced economies and costing half a million dollars per victim.

Peer-reviewed laboratory trials documented here and abroad demonstrate that the patented cure is 100% effective and presents no side effects. Victims, families, and their governments will gladly pay for the cure as it is easier to administer, provides the desired medical outcome, doubles life expectancy to 80-85 years, costs 4.0% of the current standard treatment, bolsters national productivity, reduces welfare rolls, and addresses the root cause of the disease (genetics)For over a century, a genuine cure for SCD eluded the world, until now.

Already 11 countries have awarded patents to the co-founders of SCCF for their genome-based SCD cure. $5.3 million in seed capital and 57 months of a seasoned manager can help to bring this long-awaited break-through to Phase III field trials and commercialization and to relieve humanity of this age-old scourge once and for all.

COMPANIES OVERVIEW AND BACKGROUND

Organized July 2006, SCCF is a 501(c)(3) (tax-exempt) non-profit, bio-medical research foundation in its administrative start-up phase. The SCCF board intends to partner with a more seasoned charity and expects to contract for Phase III field services to attract the necessary capital and management talent to commercialize the SCD cure in
exchange for royalty flows from a pharmaceutical.

PRODUCT AND TECHNOLOGY

The key component of the cure is ferritin-heavy chain (FtH), a protein that occurs naturally in the body. FtH deactivates the mutant sickle cell gene and reactivates a dormant, healthy replacement gene. The cure is specific to the ailment and easy to administer. The drug’s molecular composition, clinical application, and salutary effects are proprietary and patent-protected. Quite stable, it requires no refrigeration – a definite “plus” in remote, tropical distribution networks. We intend to use our patented technology known as Gene Regulation Therapy (GRT) to control gene expression without permanently altering any genes – a medical first.

GRT-SC and its pharmaceutical awardee will, in theory, be able to eliminate the expression of SCD worldwide, if it were not for two countervailing factors: (1) logistical or administrative barriers in reaching remote populations and (2) the absence of government-mandated newborn screening in third-world countries.

PREDICTED BENEFITS FOR SCD VICTIMS AND GRT-SC INVESTORS
• Double the SCD patient life expectancy from 42 to 85 years (U.S. actuarial tables).
• Save an estimated 340,300 SCD-positive infants per year and after 16 years, some 8.4 million will have been saved.
• Reduce SCD medical bills by 96%. $578 FtH treatment per patient year = 4.0% of standard full care of $14,443.
• Reach 144.5% internal rate-of-return (IRR); generate $396 million net present value (NPV) applying an 18% discount rate.
• 1X Break-even in 1 year 4 months; 2X in 2 years 1 month ; 5X in 4 years 9 months.

IRR and NPV calculations based on start-up costs of $5.259 million (2009-2012) plus $12.0 million in 2013 from pharmaceutical company, with 15 consecutive years of sales (2013-2028) grossing $223 million during 2028 the final year. The biggest “unknown” cost factor is the time-consuming U.S. Patent Office and Food & Drug Administration (FDA) regulatory process. Our business plan assumes FDA will grant approval by December 2012 with sales beginning 12 months thereafter.

MANAGEMENT – “THE TEAM”
• Chairman & Founder Robert Broyles, PhD – President of SCCF, Professor of Biochemistry & Molecular Biology, Principal Investigator and specialist, discoverer of the SCD cure. Strengths: comprehensive scientific analysis and biomedical grant manage-ment. BS chemistry and PhD biochemistry - Wake Forest Univ., National Institutes of Health post-doctoral fellowship. Community service: American Red Cross, Boy Scouts, First Unitarian Church - Oklahoma.

• Director of Development (designate) Gary BrickerCFP – Third World health finance specialist. Strengths: financial feasibility and program management. political science studies – la Sorbonne, BA - economics University of Connecticut, MS - urban planning Columbia University. USAID (Zambia, Somalia, Indonesia, El Salvador, Tunisia, Georgia, Morocco) – 24 years. Community service: School without Boundaries, Black Sea University, First Unitarian Church - Oklahoma City.

• CFO & Director of Development, To Be Determined CPA and/or MBA. At least five years of progressively responsible experience in fund raising (grants, loans, venture
capital, and “S” corp shares). Project incubator skills, advice on corporate tax, legal requirements, and filings. Strengths: objective personnel assessments, leadership skills, and team building advice. Commitment to the humanitarian goals of the SCCF and GRT-SC. A vision of commercialization that goes beyond “for-profit’ only.

MARKET OPPORTUNITY
Market size of SCD patients has remained historically small (107,000 patients, US & Europe) due to low survival rates. With the introduction of the cure, the contingent of
sickle cell survivors could grow by an estimated 340,300 each year. A potential competitor, Bristol-Myers Squibb (BMS), the manufacturer of hydroxyurea (HU), has not pursued a genetic path to an SCD cure. We predict BMS will not resist our market entrée, since the proposed cure is superior to standard care both medically and financially. XEchem, Inc. of Nigeria has relevant FDA patent applications pending. Our understanding is that its product Nicosan™ is palliative in nature and does not function through gene regulation.

In exchange for royalty payments, we intend to negotiate an exclusive licensing agreement with a competitively selected pharmaceutical company (or consortium) to design and fund Phase III trials and begin marketing as soon as 12 months thereafter. Reported innovations to accelerate FDA review procedures could shorten the 57-month start-up period, thereby strengthening financial ratios, and increasing investors’ return- on-investment. We would prefer licensing to an American-registered company but are actively considering European options in view of our existing European patents and Europe’s established drug distribution networks into Africa where 75% of the SCD caseload resides. Year 1 marketing would focus on Europe and the Americas, the two highest income WHO regions, to allow for a cross-subsidy approach to take hold.

FUNDS SOUGHT, FINANCIAL PROJECTIONS, AND EXIT STRATEGY
We seek aggregate commitments of $5.3 million in grants, venture seed capital, discount rate loans, and/or commercial promissory notes disbursed against pre-agreed performance-based draws for up to four years.

In a gesture of corporate social responsibility, our licensing agreement will commit the winning pharmaceutical company to lower or maintain prices steady as long as possible. We will also encourage GRT-SC shareholders to contribute generously to the SCCF research agenda. Liquidation may occur only after markets demonstrate pre- agreed measures of predictability and stability and after consideration of post-patent generic options.

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