Center in California now offering Zevaskyn treatment for RDEB
Approved gene therapy now available to patients in Chicago, San Francisco
Lucile Packard Children’s Hospital Stanford, a medical facility in the San Francisco Bay Area, has completed the requirements needed to become a qualified treatment center for Zevaskyn (prademagene zamikeracel), a gene therapy approved earlier this year for recessive dystrophic epidermolysis bullosa (RDEB), according to a press release.
The center announced that it is now ready to accept patients with the skin disorder for treatment with Zevaskyn. The California center becomes the second, and the first on the West Coast, to offer the gene therapy. The first center, in Chicago, began offering Zevaskyn in May.
“This milestone is a powerful testament to the patients participating in clinical trials, and the tireless dedication of Stanford Medicine’s scientists and medical professionals who pioneered this research,” Joyce Teng, MD, PhD, professor of dermatology at Stanford University and pediatric dermatologist at Stanford Medicine Children’s Health, said in the press release, issued by Abeona Therapeutics, the company that sells Zevaskyn.
Madhav Vasanthavada, PhD, chief commercial officer of Abeona, called the site activation “a key milestone in our commercial launch,” adding that the company is “excited that RDEB patients can now access Zevaskyn at both Lucile Packard Children’s Hospital Stanford and Lurie Children’s Hospital of Chicago.”
Hospital completes requirements to become Zevaskyn treatment center
Abeona and Stanford have been collaborating on research for more than a decade, the release noted, saying that these efforts together culminated in the U.S. Food and Drug Administration’s approval of Zevaskyn in April for adults and children with RDEB.
“We’re thrilled to announce the availability of Zevaskyn treatment at Lucile Packard Children’s Hospital Stanford and to continue our long-standing collaboration with Stanford Medicine,” Vasanthavada said.
Abeona offers a patient support program called Abeona Assist, which includes guidance about financial assistance, travel, and logistics.
We’re thrilled to announce the availability of Zevaskyn treatment at Lucile Packard Children’s Hospital Stanford and to continue our long-standing collaboration with Stanford Medicine.
RDEB is caused by mutations in the COL7A1 gene, which provides instructions to make a protein that helps skin maintain its structure. Without this protein, skin is fragile and prone to chronic wounds that don’t heal efficiently.
In Zevaskyn treatment, a patient’s skin cells are collected and engineered in a lab so they’ll carry a healthy version of the COL7A1 gene. The modified cells are then grown on a thin sheet that is grafted onto a patient’s wounds to promote healing.
In a Phase 3 clinical trial called VIITAL (NCT04227106), 11 people with RDEB had some wounds treated with Zevaskyn while others were left untreated. The results showed that wounds treated with Zevaskyn were significantly more likely to heal, by at least 50%.
“This treatment offers profound new hope for patients and families battling this life-altering, painful skin disorder,” Teng said, adding that the therapy “represents a scientific triumph and a profound step toward improving quality of life for so many.”
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