Axovant Announces Dosing of First Patient in Second Cohort of SUNRISE-PD Phase 2 Trial of AXO-Lenti-PD
April 30 2019 - 7:00AM
-Up to 6 patients to be enrolled in the second
cohort, initial data expected in fourth quarter 2019-
Axovant Gene Therapies Ltd. (NASDAQ: AXGT), a clinical-stage
company developing innovative gene therapies, announced the dosing
of the first patient of the second cohort in the SUNRISE-PD Phase 2
trial of AXO-Lenti-PD in Parkinson’s disease patients. To date, the
patient has experienced no complications related to the surgery or
to administration of the vector and has been discharged home as
planned with no serious adverse events observed. Up to 6 patients
will be dosed in this second cohort, at a dose of 1.4 x 107 TU,
which is approximately 3-fold higher than the dose evaluated in the
first cohort. The primary outcome measure in this second cohort is
safety and tolerability and a key efficacy measure will be UPDRS
Part III (motor) OFF score. Axovant expects initial data from this
cohort to be available in the fourth quarter of 2019.
“We are pleased to begin enrolling additional
patients in the SUNRISE-PD study at a higher dose level, following
encouraging 3-month data from the first cohort,” said Dr. Gavin
Corcoran, Axovant’s Chief Research and Development Officer. “We
look forward to exploring the full clinical potential of
AXO-Lenti-PD in patients with Parkinson’s disease, building upon
the safety profile and improvements in motor symptoms that have
been observed in 17 patients evaluated across the ProSavin and
AXO-Lenti-PD programs. Our focus remains on the rapid execution of
the clinical study to evaluate this important potential therapy in
patients with Parkinson’s disease.”
These details will be included in Axovant’s oral
presentation of previously announced clinical results from the
AXO-Lenti-PD study at the 22nd Annual Meeting of the American
Society of Gene & Cell Therapy (ASGCT) taking place in
Washington, DC, April 29 - May 2, 2019.
Title: AXO-LENTI-PD: a
second-generation lentiviral gene therapy for the treatment of
Parkinson’s Disease (Abstract #222)Session
date/time: April 30, 2019, 3:30-3:45pm
ETLocation: Monroe
Additional information on the meeting can be
found on the ASGCT website: http://www.asgct.org
About Axovant Gene
Therapies
Axovant, part of the Roivant family of companies, is a
clinical-stage gene therapy company focused on developing a
pipeline of innovative product candidates for debilitating
neurological and neuromuscular diseases. The company’s current
pipeline of gene therapy candidates targets GM1 gangliosidosis, GM2
gangliosidosis (including Tay-Sachs disease and Sandhoff disease),
Parkinson’s disease, oculopharyngeal muscular dystrophy (OPMD),
amyotrophic lateral sclerosis (ALS) and frontotemporal dementia.
Axovant is focused on accelerating product candidates into and
through clinical trials with a team of experts in gene therapy
development and through external partnerships with leading gene
therapy organizations. For more information, visit
www.axovant.com.
About Roivant
Roivant Sciences aims to improve health by rapidly delivering
innovative medicines and technologies to patients. It does this by
building Vants – nimble, entrepreneurial biotech and healthcare
technology companies with a unique approach to sourcing talent,
aligning incentives, and deploying technology to drive greater
efficiency in R&D and commercialization. For more information,
please visit www.roivant.com.
Forward Looking Statements and
Information
Statements contained in this press release that
are not purely historical may be deemed to be forward-looking
statements for the purposes of the safe harbor provisions under The
Private Securities Litigation Reform Act of 1995 and other federal
securities laws. Without limiting the foregoing, the use of words
such as “may,” “might,” “will,” “expect,” “plan,” and other similar
expressions are intended to identify forward-looking statements.
The product candidate discussed is investigational and not approved
and there can be no assurance that the clinical programs will be
successful in demonstrating safety and/or efficacy, that Axovant
will not encounter problems or delays in clinical development, or
that any product candidate will ever receive regulatory approval or
be successfully commercialized. All forward-looking
statements are based on estimates and assumptions by Axovant’s
management that, although Axovant believes to be reasonable, are
inherently uncertain. All forward-looking statements are subject to
risks and uncertainties that may cause actual results to differ
materially from those that Axovant expected. In addition, Axovant’s
business is subject to additional risks and uncertainties,
including among others, the initiation and conduct of preclinical
studies and clinical trials; the timing and availability of data
from clinical trials; expectations for regulatory submissions and
approvals; potential safety concerns related to, or efficacy of,
Axovant’s product candidates; the availability or commercial
potential of product candidates; and Axovant’s and its partners’
ability to perform under their license, collaboration and
manufacturing arrangements. These statements are also subject to a
number of material risks and uncertainties that are described in
Axovant’s most recent Quarterly Report on Form 10-Q for the
quarterly period ended December 31, 2018, filed with the Securities
and Exchange Commission on February 7, 2019, as updated by its
subsequent filings with the Securities and Exchange Commission. Any
forward-looking statement speaks only as of the date on which it
was made. Axovant undertakes no obligation to publicly update or
revise any forward-looking statement, whether as a result of new
information, future events or otherwise.
Contacts:
MediaMike BeyerSam Brown Inc.
(312) 961-2502mikebeyer@sambrown.commedia@axovant.com
InvestorsTricia
TruehartAxovant(631) 892-7014investors@axovant.com
Axovant Gene Therapies (NASDAQ:AXGT)
Historical Stock Chart
From Mar 2024 to Apr 2024
Axovant Gene Therapies (NASDAQ:AXGT)
Historical Stock Chart
From Apr 2023 to Apr 2024