French Regulatory Agency Agrees lacutamab TELLOMAK Trial Can Resume Recruitment in Sezary Syndrome and mycosis fungoides
Innate Pharma S.A. - American Depositary Shares (IPHA)
Company Research
Source: GlobeNewswire
Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the French National Agency for Medicines and Health Product Safety (ANSM) has agreed that the lacutamab (IPH4102) TELLOMAK Phase II trial can resume recruitment of new patients with relapsed/refractory Sézary syndrome and mycosis fungoides (MF) who have received at least two lines of prior systemic therapy. Following discussions with the Company, the ANSM decision to allow new patient recruitment to resume in Sézary syndrome and MF in France is based on an assessment of the unmet medical need and the lack of currently available standard of care options. Conversely, because standard of care options are available to patients with peripheral T-cell lymphoma (PTCL), no new patients can enroll in the trial until a new Good Manufacturing Practice (GMP)-certified batch is available. However, currently enrolled PTCL patients can continue treatment in the trial. In light
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