The Food & Drug Administration’s (FDA) approval of botanical drug Fulyzaq (Crofelemer) is of particular significance to AIDS Research Alliance. ARA was an investigational site in the clinical trial stage of the drug’s development, and ARA is working on its own botanically sourced HIV cure strategy – prostratin.
Fulyzaq is the first drug the FDA has ever approved for the treatment of HIV-related diarrhea. Diarrhea is a common side effect of the drugs prescribed to manage HIV/AIDS. The diarrhea can cause rapid weight loss and depression. The symptoms can be so severe that some patients discontinue or switch their medications prematurely. With Fulyzaq, which is taken twice daily, watery diarrhea caused by electrolyte and water secretion in the gut can be managed, allowing patients to continue their treatment regimens.
Fulyzaq (Crofelemer) marks the second time the FDA has ever approved a botanical drug. Like prostratin, Fulyzaq is plant-derived. It originates from the red sap of the Croton lechleri plant, which grows in northwestern South America. Similar to the Mamala plant, source of prostratin, which was used for centuries by Samoans to treat “yellow fever” or hepatitis, the Croton lechleri plant has a history of use by native healers in the Amazon to treat diarrhea and other health conditions.
ARA Medical Director and Vice President Dr. Stephen Brown commented on the approval, “Crofelemer marks the first new mechanism for the treatment of diarrhea in decades. The clinical trial process took a number of years, and ARA’s involvement goes back to the initial studies conducted by Shaman, and subsequently, to those conducted by Napo and Salix. “ He continued, “We have always considered this drug a very important advance in the treatment of diarrhea. Because many people are uncomfortable talking about this symptom, even with their physicians, recruitment for the studies could have been difficult. Despite this, we were very successful, indicating just how serious and persistent the underlying symptom is.”
The Centers for Disease Control and Prevention estimates that between 150,000 and 180,000 patients on ART suffer from diarrhea (not caused by infection or a gastrointestinal disease).
Salix Pharmaceuticals distributes Fulyzaq in the USA, under license from Napo Pharmaceuticals Inc.
In February 2013, AIDS Research Alliance (ARA) received a generous bequest of $100,000 from the Susan A. Miller 2010 Trust. ARA was in great company, including the Muscular Dystrophy Association and the American Cancer Society.
A planned gift has the potential to create a lasting impact and a meaningful legacy. For Ms. Miller, her gifts will strengthen scientific research and health services for years to come.
What do you want your legacy to be? If it includes a cure for HIV/AIDS, please consider a gift to AIDS Research Alliance when planning the final distribution of your assets.
Learn more about legacy giving and how to join our Legacy Circle. And if you have named ARA in your estate plans, we encourage you to let us know by contacting our Development Director, Lilian Miller, at development@aidsresearch.org.
ARA staff receives We-Care check |
“Shop and Support” programs are a fantastic way for people to support their chosen cause without spending an extra dime. In the last year, ARA has partnered with one Shop & Support organization that has proven to be particularly fruitful – We-Care.com. Through We-Care.com, when ARA supporters shop at various online vendors, a portion of the sale is funneled back to support ARA.
In December, We-Care.com featured ARA as the Cause of the Month. As a result of this exposure, We-Care.com and its users raised $38,255.17 for ARA, enough to pay for the eight leukapheresis experiments necessary for the advancement of our promising HIV cure research. While We-Care.com users typically select one favorite cause to support with their online shopping, the Cause of the Month campaign introduces undecided users to a particular cause. Thousands of We-Care.com users chose to participate in December and earn donations for ARA as they shopped, booked travel, and searched online – at no extra cost to them. Their participation raised $38,255.17 in micro-donations, enough to complete the next stage of prostratin research.
“In honor of World AIDS Day, and a strong partnership with the organization, We-Care.com chose AIDS Research Alliance as December’s Cause of the Month,” explained Gina Navani, Director of Operations at We-Care.com. “Since the opportunity provides undecided We-Care.com users with basic information about the organization and encourages additional support, the company grew excited about the possibility of collaborating with its users and merchants to support ARA’s prostratin research project.”
Prostratin, ARA’s cure strategy, is a promising drug candidate that has been shown to expose latent HIV in cell reservoirs. In an HIV-positive body, the virus hides in “reservoirs,” inhibiting the effectiveness of current drug therapies. A persistent obstacle in curing HIV/AIDS is drawing the virus out of these reservoirs to rid the body of the virus. ARA’s Medical Director, Dr. Stephen Brown, explained, “The leukapheresis experiments will allow ARA researchers to assess prostratin’s effectiveness as a therapy to eradicate HIV, allowing researchers to extract white blood cells from blood samples. Researchers are unable to obtain enough white blood cells from a blood draw, but with leukapheresis, white blood cells can be taken from blood and the red cells and plasma can be returned into the patient.” The We-Care.com donations will allow ARA to advance its prostratin research, moving the world closer to a cure, and an AIDS-free generation.
Have you downloaded the We-Care.com application?
Visit ara.we-care.com and give while you shop!