World News: 12:00 GMT Thursday 6th December 2018. [Axovant Sciences Ltd. via Globe Newswire via SPi World News]
BASEL, Switzerland, Dec. 06, 2018 (GLOBE NEWSWIRE) -- Axovant Sciences (NASDAQ: AXON), a clinical-stage company developing innovative gene therapies for neurological conditions, today announced feedback from a face-to-face pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding AXO-Lenti-PD for patients with Parkinson’s disease. Based on the discussion at the meeting, the totality of data collected on the initial vector construct, ProSavin, including over six years of phase 1/2 clinical data and IND-enabling preclinical data, may be supportive of the planned development program for AXO-Lenti-PD.
The phase 2 clinical trial of AXO-Lenti-PD (NCT03720418), now called SUNRISE-PD, was initiated in the U.K. in the fourth quarter of 2018. The SUNRISE-PD study is advancing as planned with dosing of the second patient in November 2018. To date, both patients tolerated the surgical procedure well and were discharged home with no serious adverse events observed. Axovant expects to announce data from the first two patients in March 2019.
During the meeting discussion and subsequent written meeting minutes, Axovant received feedback from the FDA on several key features of the AXO-Lenti-PD development program:
In addition, Axovant was encouraged to return for an End-of-Phase 2 meeting after completion of the ongoing SUNRISE-PD study, during which the available data generated in the study will be discussed in the context of a pivotal program design.
“We are pleased with the feedback received at our meeting with the FDA, which reaffirmed our strategy to view the ongoing SUNRISE-PD clinical study of AXO-Lenti-PD as a continuation of the previous ProSavin program, and part of a single development program,” said Gavin Corcoran, M.D., executive vice president of research and development for Axovant. “We believe we are well-positioned to continue to execute on the clinical trial as designed, manufacture drug product at scale, and activate clinical trial sites in the U.S. during the randomized, sham-controlled portion of our SUNRISE-PD study.”
Globe Newswire: 12:00 GMT Thursday 6th December 2018
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