AGTC Announces Financial Results And Business Update For The Quarter Ended September 30, 2016

GAINESVILLE, Fla., and CAMBRIDGE, Mass., Nov. 08, 2016 (GLOBE NEWSWIRE) -- Applied Genetic Technologies Corporation (NASDAQ:AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, today announced financial results for the quarter ended September 30, 2016.

"Over the past quarter, we have remained focused on efficiently enrolling the clinical trials of our lead product candidates for X-linked retinoschisis and achromatopsia caused by mutations in the CNGB3 gene," said Sue Washer, President and CEO of AGTC. "We recently filed an IND for our product candidate to treat patients with achromatopsia caused by mutations in the CNGA3 gene and we look forward to initiating a Phase 1/2 clinical study for that product candidate in the coming months while continuing to advance our XLRS and achromatopsia B3 programs."

Recent Highlights
  • In October 2016, the company filed an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA) to conduct a Phase 1/2 clinical trial of the company's gene therapy product candidate for the treatment of achromatopsia, or ACHM, caused by mutations in the CNGA3 gene. 
  • In October 2016, the company completed enrollment of patients in the middle dose group in a Phase 1/2 clinical trial of its XLRS product candidate and in the low dose group in its Phase 1/2 clinical trial of its ACHM B3 product candidate.

XLRS Phase 1/2 Clinical Trial

AGTC is currently enrolling patients in a Phase 1/2 clinical trial for its XLRS product candidate, a program on which the company is collaborating with Biogen.  The clinical protocol anticipates enrollment of up to 27 patients.  This trial is currently being conducted at seven clinical sites that specialize in inherited retinal diseases.

As of October 2016, the company has enrolled a total of nine patients - six of whom are in the low dose group and three are in the middle dose group, which completes enrollment in those two groups.  As specified in the clinical trial protocol, data from the first nine patients will be reviewed by a Data and Safety Monitoring Committee, or DSMC, before the company enrolls patients in the high dose group.

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