Ygalo® is a peptidase potentiated alkylator, a type of cytotoxic drug. Ygalo® differs from current cytotoxics through its unique ability to achieve higher concentrations of cancer killing molecules in cancer cells without a corresponding increase in damage to the patient’s bone marrow. Pre-clinical studies also show that Ygalo® kills on average 50 times more cancer cells than similar classes of treatment.
Ygalo® is intended to be the first choice for the treatment of patients with late-stage relapsed and refractory multiple myeloma. Multiple myeloma is a haematological cancer with no cure and a median survival period of approximately 5 years from diagnosis. Patients in the late stages of multiple myeloma suffer from symptoms including skeletal pain, bone fractures and infections associated with a weakened immune system as well as from the side effects of the treatments available today.
Comparing clinical data between Ygalo® and the current standard of care in late-stage multiple myeloma indicates that treatment with Ygalo® increases overall survival, progression free survival and the number of patients with significant tumour burden reduction as well as being better tolerated by patients.
The pivotal Phase 3 clinical study approved under the US Food and Drug Administration’s Special Protocol Assessment where Ygalo® will be compared directly against the current standard of care in patients suffering late-stage multiple myeloma started in June 2017.
As a rare condition, multiple myeloma is classified as an orphan disease in the US and Europe and Ygalo® has been granted orphan drug designation by the relevant authorities in both these jurisdictions.