The Van Trump Report

First GE Pigs Approved by FDA

Pigs are the newest species of genetically engineered animals to win U.S. approval for food use, potentially helping people with meat allergies. The “GalSafe” pigs were also given the green light by the Food and Drug Administration (FDA) to be used for medical purposes, such as the production of drugs or even organ transplants. The approval comes five years after AquAdvantage salmon became the first GE animal approved for human consumption but the GalSafe pigs are the first to be approved for both food and medical uses, according to the FDA.

The pigs come from biotech company Revivicor, which calls itself a “regenerative medicine company.” They’ve been genetically altered to remove a sugar molecule known as “alpha-gal” that is found in the tissue of many mammals, including pigs, cows, and sheep. Alpha-gal can cause severe, life-threatening allergic reactions in some people. The allergy is believed to be a lifelong side effect from the bites of certain species of ticks. There is no treatment other than to avoid red meat and other products made from mammals.

An exponentially greater number of people could be helped by the potential medical uses of the GalSafe pigs, which goes far beyond allergic reactions. Alpha-gal is also thought to cause tissue and organ rejection in people who receive xenotransplants, or transplants between species. For example, a company called XenoTherapeutics is conducting a trial using pig skin from the GalSafe pigs to treat burn victims. The current clinical standard of care is using human cadavers to obtain graft material, but the availability is severely limited. The Xeno-Skin therapy they’ve created can be mass-produced and even stored for later use. It has already been cleared by the FDA for investigational use in human patients suffering severe and extensive burn wounds.    
Another application could be for making certain drugs like drug-thinner heparin. They also have ambitions to tackle solutions for Type 1 diabetes and, later down the pipeline, developing GE pigs capable of producing fully human antibodies for use as vaccines against infectious agents (ie. anthrax, MRSA, H1N1, HIV). It’s important to note that any companies that want to use GalSafe pigs in medical products would need to gain separate approval from the FDA for those medical uses.

As far as food production is concerned, the statement notes that the meat is safe for consumption by the general population, adding that Revivicor “intends to sell meat from GalSafe pigs by mail order, rather than in supermarkets.”

Revivicor’s history actually traces back to the UK company PPL Therapeutics, which produced the very first cloned animal, Dolly the Sheep. Based in Virginia, the Revivicor spin-off was formed in 2003. Learn more from their website HERE. (Sources: LiveScience, Bloomberg, GenomeWeb)

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