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Portola Pharmaceuticals Announces Initiation of Phase 1/2 Clinical Study of PRT2070
"We are pleased to advance our third wholly-owned program focused on addressing an unmet medical need into the clinic. Our goal with PRT2070 is to develop an effective and well- tolerated oral drug for the thousands of lymphoma and leukemia patients who are impacted by difficult- to-treat genetic subtypes or who become unresponsive to available therapies," said
The open-label, multicenter, Phase 1/2 proof-of-concept study will assess the safety, pharmacokinetics, pharmacodynamics and clinical activity of oral PRT2070. In the multi-dose, dose-escalation Phase 1 part of the study, PRT2070 will be administered to sequential dose cohorts at increasing dose levels until the maximum tolerated dose is identified. The Phase 1 portion of the study can include patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma and non-Hodgkin lymphoma (
PRT2070 is an oral, potent inhibitor of both the B-cell receptor (BCR) pathway (via Syk) and important cytokine signaling (via JAK) that promote survival and proliferation of hematologic cancers, such as chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (
Portola is currently evaluating PRT2070 in a Phase 1/2 clinical study and has worldwide rights to develop and commercialize the agent for hematologic cancers and other systemic indications. Rights for certain nonsystemic indications are shared 50/50 with Aciex Therapeutics.
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the use of PRT2070 as a kinase inhibitor and any of Portola's clinical trials, including Portola's Phase 1/2 proof-of-concept study for PRT2070. Risks that contribute to the uncertain nature of the forward-looking statements include: the accuracy of Portola's estimates regarding its ability to initiate and/or complete its clinical trials; the success of Portola's clinical trials and the demonstrated efficacy of Portola's product candidates thereunder; the accuracy of Portola's estimates regarding its expenses and capital requirements; regulatory developments in
*PRT4445 has a proposed International Nonproprietary Name (pINN) of andexanet alfa.