SCD is a disease that co-evolved with malaria among peoples living in equatorial regions where mosquitoes are endemic and serve as vectors for the malaria parasite. In the US, over 70,000 individuals are afflicted with SCD. Globally, an estimated 880,000 die from malaria and 340,000 from SCD annually, with the great majoriy of these deaths being children under the age of five years. SCD afflicts many in western and central African countries, as well as people of Portuguese, Spanish, French Corsican, Sardinian, Sicilian, Italian, Greek, Turkish, Cypriot, Israeli, Arab, and Indian decent. While one copy of the sickle gene confers resistance to the malaria parasite, carrying two copies can result in death. Large public health measures have limited the spread of malaria in developed countries. In contrast, SCD has been neglected. The wide spread occurrence of SCD and recent resurgence of malaria motivated the World Health Organization in May 2006 to list SCD as a neglected disease warranting intensified research. SCCF is mounting a global effort to address this global health problem.

Gene Regulation Therapy (GRT) is the overall research approach employed by SCCF. GRT does not destroy genes, alter them, nor implant them in the patient. Rather, SCCF has discovered how to manipulate “toggle switches” that reactivate the body’s own fetal hemoglobin production. Medical literature has amply documented that the presence of fetal hemoglobin in adult red blood cells at concentrations of 30% or more confers a natural resistance to SCD…and also to malaria. Requiring no refrigeration, the GRT for SCD is natural, non-invasive, and reversible. To maintain its benefits, the patient only requires periodic “recharge” doses to keep the toggle switch “on.” Similar GRT-responsive, “onoff” genetic relationships are the subject of translational research and development. GRT promises effective clinical treatments for many debilitating disorders including diabetes, Parkinson’s, Huntington’s, liver diseases, and certain cancers. SCCF’s business plan for global distribution of Gene Regulation Therapy for SCD estimates a 95% drop in the cost of standard Western treatments. Whereas current treatments only address the symptoms of SCD, SCCF’s approach corrects the primary cause. For the world’s poor majority, SCCF’s business model uses cross-subsidy pricing to deliver the cure to Africa pharmaceutical outlets for as little as US $12.00 per person per year.

Dr. Broyles’ project is one of 78 grants announced by the Gates Foundation in the fourth funding round of Grand Challenges Explorations, an initiative to help scientists around the world explore bold and largely unproven ways to improve health in developing countries. The grants were provided to scientists in 18 countries on six continents.

To receive funding, Dr. Broyles showed in a two-page application how his idea falls outside current scientific paradigms and might lead to significant advances in global health. The initiative is highly competitive, receiving almost 2,700 proposals in this round.

The research of Dr. Broyles and The Sickle Cell Cure Foundation, Inc., of Oklahoma City. will build on the recent discovery that elevated fetal hemoglobin (HbF), which alleviates sickle cell disease, can also confer malaria resistance. Broyles and his team will test the ability of a stable human protein to reactivate a silent gene that encodes for HbF, making red blood cells inhospitable to malaria parasites. If successful, the idea is to target the therapy in the host to reduce malaria infections.
Dr. Broyles earned the Ph.D. degree in biochemistry from Wake Forest University Medical Center, Winston-Salem, N.C., did postdoctoral research at Florida State University, has held faculty positions at the University of Wisconsin -Milwaukee and the University of Oklahoma Health Sciences Center, and has served as a visiting research scientist at the National Institutes of Health, the Woods Hole Marine Biological Laboratory, and the Oklahoma Medical Research Foundation. In 2006, Dr. Broyles founded The Sickle Cell Cure Foundation, Inc. (SCCF), a 501(c)(3) nonprofit research foundation dedicated to a universal cure for sickle cell and related diseases.
“We have discovered a way of shutting off the sickle cell gene and reactivating a fetal hemoglobin gene in its place, a switch known to stop all the bad, deadly manifestations of SCD,” says Broyles. “The realization that this same manipulation will make people resistant to malaria is even more exciting.”

“The winners of these grants show the bold thinking we need to tackle some of the world’s greatest health challenges,” said Dr. Tachi Yamada, president of the Gates Foundation’s Global Health Program. “I’m excited about their ideas and look forward to seeing some of these exploratory projects turn into life-saving breakthroughs.”

About Grand Challenges Explorations

Grand Challenges Explorations is a five-year, $100 million initiative of the Gates Foundation to promote innovation in global health. The program uses an agile, streamlined grant process – applications are limited to two pages, and preliminary data are not required. Proposals are reviewed and selected by a committee of foundation staff and external experts, and grant decisions are made within approximately three months of the close of the funding round.

Applications for the current round of Grand Challenges Explorations are being accepted through May 19, 2010. Grant application instructions, including the list of topics for which proposals are currently being accepted, are available at http://www.grandchallenges.org/explorations.

• SCCF submits the Continuation in Part (CIP) containing all our experimental results with human pediatric sickle cell patients’ blood to the U.S. Patent Office, March 15, 2009.
• The U.S. Patent on our sickle cell cure is issued the following month, 4/14/09.
• SCCF’s patents in the U.S., Canada, Australia, and the European Union (U.K., France, Germany, and Greece) are maintained, and their annuities paid.
• The Institutional Review Board (IRB) Protocol for our experiments with human blood from pediatric sickle cell patients is continued for 2009-2010, the 5th consecutive year for this approval rating by the OUHSC IRB for Protection of Human Subjects, acting on behalf of the NIH. These strictly regulated protocols are a critical prerequisite to determine safe and effective dosages before clinical trials in human beings.
• SCCF launches our new website in magazine format with comments/blog wherein sickle cell patients from around the world may express their concerns and questions in spring 2009, incorporating the capability for on-line donations: www.sicklecellcurefoundation.org
• International RFPP (Request for Proposals to Partner) with SCCF is written by Director of Development, Gary Bricker, and issued (1st round) in summer, 2009.
• SCCF submits a grant proposal to the Bill & Melinda Gates Foundation on November 2, 2009, for their Grand Challenges Explorations, Round 4. Our proposal profiles a method the Sickle Cell Disease cure may be used to alleviate and even prevent the tragedy of Malaria. This proposal cleared the hurdle of first level review and is still pending (final decisions, April 2010).
• SCCF’s first animal trials in mice approved by the OUHSC Institutional Animal Care and Use Committee (IACUC), November 11, 2009.
• New collaboration with Dr. Sunil Joshi, OUHSC, is formed for second phase of animal trials, using transgenic mouse models for human sickle cell disease, December 2009. Stay tuned for developing synergies!
• International publicist Laura Jenney joins the “team” of SCCF and J.R. Perry III, to promote SCCF and the “Cure Every Cell” fundraising music tour, December 2009.

• SCD is the most prevalent genetic disease globally.
• SCD occurs in many nations and among many races — wherever malaria was once or is still rampant.
  • The Sickle Cell Cure Foundation has a cure for SCD.
  • The SCCF’s cure will give SCD sufferers a normal life.
  • The SCCF’s cure also provides malaria resistance.
  • The SCCF has a global plan for cure distribution.
  • The SCCF needs your help to save lives.

  What can you do?

  • Become a Sickle Cell Cure Foundation member today.
  • Donate NOW: help stop 500,000 deaths/year.
  • Pass the word to your friends and acquaintances.
  • Give generously and regularly.

  Why this cure will work worldwide…

  • The SCCF’s cure is based on the biology of our bodies.
  • The SCCF’s cure does not alter genes, is not invasive.
  • The SCCF’s cure does not rely on stem cells.
  • The SCCF’s cure uses a protein we grow up with.
  • The SCCF’s discovery gets this protein to the right cells.
  • The SCCF’s cure is stable, inexpensive, easy to deliver anywhere.
  • Other cure attempts are out of reach for most people.
  • Other cure attempts have severe side effects.
  • Current treatments are costly and incomplete.

  You can make a difference in someone’s life. Please help end the suffering.

  Mail checks to:
  Sickle Cell Cure Foundation, Inc.,
  212 ½ NW 20th St.,
  Oklahoma City, OK, 73103;
  or donate through PayPal online at http://www.sicklecellcurefoundation.org.

Our cure has been peer-reviewed via Publications & Patents, Grants Awarded, and invitations for International Presentations.

Publications & Patents: PDF files of a List of 25 Publications; a key paper that established the principle of the cure; and our Patent issued in the U.S., the European Union(10 countries), and Australia, are attached.

• Publications List
• PNAS 2001
• US Patent #7,517,669 (FtHgenetransduction)

Grants Awarded: A PDF file of an NIH-form 4-page bio-sketch is attached, with the last two pages listing NIH and other nationally-competitive grants. Dr. Broyles’ curriculum vitae is also attached.

• Dr. Robert Broyles CV
• Grants (pp3&4) & NIH biosketch

International presentations: PDF files of abstracts of nine invited, international presentations (2003 through 2009) are attached.

• 2003 IBIS Bethesda.pdf
• 2004 ISSCR Boston.pdf
• 2005 IBIS Prague.pdf
• 2006 ASH Orlando.pdf
• 2006 NSCD Memphis.pdf
• 2007 IBIS Kyoto.pdf
• 2007 SFRBM Washington, DC.pdf
• 2008 SCDAA NewOrleans.pdf
• 2009 IBIS Porto.pdf