Sellas Life Sciences Group Receives Orphan Drug Designation For SLS009 For Treatment Of PTCL

(RTTNews) - Sellas Life Sciences Group, Inc. (SLS) announced Thursday that the FDA has granted Orphan Drug Designation for its selective CDK9 inhibitor SLS009 for the treatment of relapsed/refractory Peripheral T-cell Lymphomas or PTCL.

In the pre-market session, SLS shares are at $1.28, up 4.92 percent from the previous close of $1.22 on a volume of 836,042.

Angelos Stergiou, CEO said, "In the recently completed dose-escalation portion of the Phase 1 trial in r/r hematological malignancies, SLS009 achieved clinical responses in PTCL including two patients reaching complete response. We are excited to see a favorable safety profile, strong initial efficacy signals, and evidence of anti-tumor activity across the Phase 1 study as well as the ongoing Phase 2 studies."

SLS009 is currently being evaluated in a Phase 1b/2 trial in patients with r/r PTCL. The open-label, single-arm study will enroll up to 95 patients.

The FDA's Orphan Drug Designation is intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States.