SEC Filings

8-K
AVEXIS, INC. filed this Form 8-K on 12/13/2017
Entire Document
 

Exhibit 99.2

 

 

 

Media Inquiries:

 

Lauren Barbiero

 

W2O Group

 

646-564-2156

 

lbarbiero@w2ogroup.com

 

 

 

Investor Inquiries:

 

Jim Goff

 

AveXis, Inc.

 

650-862-4134

 

jgoff@avexis.com

 

AveXis Announces Plan to Initiate Phase 1 Trial in SMA Type 2 Utilizing

Intrathecal Delivery of AVXS-101

 

– The FDA notified AveXis it may initiate the Phase 1 trial in SMA Type 2 based on a review of data provided by the company; trial to commence immediately –

 

– The trial will evaluate safety, dosing and proof of concept for efficacy –

 

– The trial will use product produced from the new GMP process at the AveXis facility –

 

– Conference call and webcast today at 4:30 p.m. EST –

 

Chicago, Ill. (December 13, 2017) — AveXis, Inc. (NASDAQ: AVXS), a clinical-stage gene therapy company developing treatments for patients suffering from rare and life-threatening neurological genetic diseases, today announced the U.S. Food and Drug Administration (FDA) has notified the company that, based on review of data submitted, the company may initiate its planned Phase 1 clinical trial of AVXS-101 for patients with spinal muscular atrophy (SMA) Type 2 via the intrathecal (IT) route of administration, using material produced by the company’s Good Manufacturing Practice (GMP) commercial manufacturing process at the AveXis manufacturing facility. The company plans to initiate this trial immediately.

 

“We are quite pleased to initiate our first trial of AVXS-101 in patients with SMA Type 2,” said Sean Nolan, President and Chief Executive Officer of AveXis. “Our goal has been to expand the study of gene therapy beyond Type 1 infants to address the urgent medical needs of children with SMA Type 2, and we look forward to understanding the potential clinical impact of AVXS-101 in these patients who, left untreated, will never walk on their own and most will never stand without assistance.”

 

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