CLEVELAND, Ohio – Abeona Therapeutics Inc. (Nasdaq: ABEO), a commercial-stage biopharmaceutical company developing genetic medicines for serious diseases with high unmet need, today announced activation of the Children’s Hospital of Philadelphia (CHOP) as the sixth Qualified Treatment Center (QTC) for the administration of ZEVASKYN (prademagene zamikeracel) gene-modified cellular sheets.
“Activation of CHOP is a significant step forward for the Recessive dystrophic epidermolysis bullosa (RDEB) community expanding access to ZEVASKYN in the east coast,” said Dr. Madhav Vasanthavada, Chief Commercial Officer of Abeona. “We are excited to collaborate with Dr. Marissa J. Perman and her team, global leaders in pediatric care and pioneers in gene and cell therapy innovation, to enable more patients an opportunity to receive ZEVASKYN treatment.”
“CHOP is proud to be named a treatment center for ZEVASKYN,” said Marissa J. Perman, MD, Section Chief of Dermatology and Director of the Epidermolysis Bullosa Multidisciplinary Clinic at Children’s Hospital of Philadelphia. “This designation underscores our dedication to delivering leading-edge care and expanding access to promising new therapies that have the potential to enhance quality of life for patients with RDEB and their families.”
For more information about receiving ZEVASKYN treatment at CHOP, contact the Epidermolysis Bullosa Multidisciplinary Clinic at [email protected] or call 215-590-1930.
For more information on how to access ZEVASKYN and learn about patient support services offered through Abeona Assist®, Abeona’s comprehensive patient support program, visit www.abeonaassist.com, call 1-855-ABEONA-1 (1-855-223-6621) or email [email protected]. Abeona Assist offers personalized support, including helping eligible patients understand their insurance benefits and financial assistance options, and providing travel and logistical assistance.
Marissa J. Perman, MD, has been a paid consultant to Abeona Therapeutics.
About recessive dystrophic epidermolysis bullosa
Recessive dystrophic epidermolysis bullosa (RDEB), a rare blistering disorder without a cure, is characterized by severe skin wounds that cause pain and can lead to systemic complications impacting the length and quality of life. People with RDEB have a defect in both copies of the COL7A1 gene, leaving them unable to produce functioning type VII collagen, which is necessary to anchor the dermal and epidermal layers of the skin.
About ZEVASKYN® (prademagene zamikeracel) gene-modified cellular sheets
ZEVASKYN is the first and only autologous cell sheet-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). RDEB is a severe skin disease caused by a defect in both copies of the COL7A1 gene resulting in the inability to produce functional type VII collagen. Without functional type VII collagen and anchoring fibrils, the skin is fragile and blisters easily, leading to wounds that continually open and close, or fail to heal altogether. Patients often have large open wounds that can lead to serious life-threatening complications. ZEVASKYN incorporates the functional type VII collagen-producing COL7A1 gene into a patient’s own skin cells, ex vivo, using a replication-incompetent retroviral vector to produce functional type VII collagen in treated wounds. ZEVASKYN has demonstrated clinically meaningful wound healing and pain reduction with a single surgical application. For more information, visit www.ZEVASKYN.com.
Indication
ZEVASKYN® (prademagene zamikeracel) is an autologous cell sheet-based gene therapy indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).
Important Safety Information
- Serious allergic reactions to ZEVASKYN can occur. Patients should get medical help right away if they experience symptoms like itching, swelling, hives, difficulty breathing, runny nose, watery eyes, or nausea. In rare cases, a severe reaction called anaphylaxis may happen.
- There is a potential risk that treatment with ZEVASKYN may contribute to the development of cancer because of how the therapy works. Patients should be monitored for the rest of their lives to check for any signs of cancer.
- ZEVASKYN is made using human and animal materials. Although these materials are tested before use, the risk of passing on infections cannot be eliminated.
- The most common side effects are pain from the procedure and itching.
This is not a complete list of side effects. Patients should call their care team for medical advice about side effects. Side effects may be reported to Abeona at 1-844-888-2236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See full Prescribing Information.
About Abeona Therapeutics
Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company developing cell and gene therapies for serious diseases. Abeona’s ZEVASKYN® (prademagene zamikeracel) is the first and only autologous cell-based gene therapy for the treatment of wounds in adults and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). The Company’s fully integrated cell and gene therapy cGMP manufacturing facility in Cleveland, Ohio serves as the manufacturing site for ZEVASKYN commercial production. The Company’s development portfolio features adeno-associated virus (AAV)-based gene therapies for ophthalmic diseases with high unmet medical need. Abeona’s novel, next-generation AAV capsids are being evaluated for a variety of devastating diseases. For more information, visit www.abeonatherapeutics.com.
ZEVASKYN®, Abeona Assist®, Abeona Therapeutics®, and their related logos are trademarks of Abeona Therapeutics Inc.
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VP, Investor Relations and Corporate Communications
Abeona Therapeutics
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Investor Contact
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