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Citius Pharmaceuticals Reports Topline Data from the Pivotal Phase 3 Study of Cancer Immunotherapy I/ONTAK (E7777) for the Treatment of Persistent or Recurrent Cutaneous T-Cell Lymphoma (CTCL) in Support of BLA Submission
CRANFORD, N.J., April 6, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company
About this update from Citius Pharmaceuticals, Inc.
[{"type":"text","content":"CRANFORD, N.J., April 6, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (\"Citius\" or the \"Company\") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products in oncology, anti-infectives in adjunct cancer care, unique prescription products, and stem cell therapies, today reported topline results from the pivotal Phase 3 trial of I/ONTAK (E7777), an engineered IL-2-diphtheria toxin fusion protein, for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL). The topline results for I/ONTAK (denileukin diftitox), a purified and more bioactive formulation of previously marketed ONTAK®, were consistent with the prior formulation. Moreover, no new safety signals were identified. Based on this data, Citius anticipates filing a biologics license application (BLA) with the U.S. Food and Drug Administration (FDA) in the second half of 2022.\n\n \n \n \n \n \n \n\n \n\"We are encouraged by the results of the study, which we believe are clinically meaningful, and are hopeful that I/ONTAK will be an important treatment option for patients with persistent or recurrent CTCL. There is no single standard of care for this orphan disease. We believe the full body of data from this and prior studies will support a successful reintroduction of denileukin diftitox to the market. We are eager to move forward with a BLA submission for the treatment of CTCL later this year. This important milestone brings Citius one step closer to launching its first commercial product next year, if approved by the FDA,\" stated Myron Holubiak, Chief Executive Officer of Citius.\n\"The topline results demonstrated anti-tumor activity in the treatment of persistent or recurrent CTCL, an incurable disease. Based on the topline data, I/ONTAK provided disease control without cumulative toxicity. I/ONTAK has a unique dual mechanism of action that exerts both direct tumor cell killing and transient elimination of immunosuppressive Tregs within the tumor microenvironment. The topline data further demonstrate that I/ONTAK has an average time to response within one to two cycles of treatment in patients that have failed multiple prior therapies. If approved, we believe this biologic with its observed efficacy and safety data, and which is already approv...