Arrowhead Provides Update on IND for ARC-520 Phase 2b Study
January 12 2015 - 6:59AM
Business Wire
Arrowhead Research Corporation (NASDAQ: ARWR), a
biopharmaceutical company developing targeted RNAi therapeutics,
today announced that the U.S. Food and Drug Administration (FDA)
verbally informed the Company in a preliminary call of a partial
clinical hold, under which the Company is cleared to begin a
modified multiple-dose study of ARC-520 in patients with chronic
hepatitis B infection. The FDA requested that the Company start the
multiple-dose study at 1 mg/kg of ARC-520 rather than the proposed
parallel study design of 2 and 4 mg/kg, and requested additional
information be provided to the agency. The additional information
includes a final study report from the single-dose Phase 2a study
in patients who received 1-4 mg/kg ARC-520, which is ongoing and
has not reported any serious adverse events or evidence of end
organ toxicity to date. The FDA also requested a final study report
from an ongoing multiple-dose non-clinical study, which has shown
ARC-520 to be well tolerated with no evidence of end organ toxicity
to date. The FDA committed to provide the Company with a letter
detailing its thoughts and requests within 30 days. The ongoing
Phase 2a study continues as planned, and the Company expects to
file with Asian and European agencies to begin additional Phase 2b
studies in coming weeks.
“Over the next 30 days, Arrowhead will begin preparations for
the multiple-dose Phase 2b study,” said Arrowhead President and
CEO, Dr. Christopher Anzalone. “We will work closely with the FDA
throughout this process while we continue to seek approval to
proceed with other planned studies in Asia and Europe.”
About ARC-520
Arrowhead’s RNAi-based candidate ARC-520 is being investigated
in the treatment of chronic HBV infection. The small interfering
RNAs (siRNAs) in ARC-520 intervene at the mRNA level, upstream of
the reverse transcription process where current standard of care
nucleotide and nucleoside analogues act. Arrowhead is investigating
ARC-520 specifically, to determine if it can be used to achieve a
functional cure, which is an immune clearant state characterized by
hepatitis B s-antigen negative serum with or without
sero-conversion. Arrowhead has completed a Phase 1 single ascending
dose study in normal volunteers and the company is conducting a
single dose Phase 2a study in chronic HBV patients. Approximately
350-400 million people worldwide are chronically infected with the
hepatitis B virus, which can lead to cirrhosis of the liver and is
responsible for 80% of primary liver cancers globally.
About Arrowhead Research Corporation
Arrowhead Research Corporation is a biopharmaceutical company
developing targeted RNAi therapeutics. The company is leveraging
its proprietary Dynamic Polyconjugate™ delivery platform to develop
targeted drugs based on the RNA interference mechanism that
efficiently silences disease-causing genes. Arrowhead’s pipeline
includes ARC-520 for chronic hepatitis B virus, ARC-AAT for liver
disease associated with Alpha-1 antitrypsin deficiency, and
partner-based programs in obesity and oncology.
For more information please visit
http://www.arrowheadresearch.com, or follow us on Twitter
@ArrowRes. To be added to the Company's email list and receive news
directly, please visit
http://ir.arrowheadresearch.com/alerts.cfm.
Safe Harbor Statement under the Private Securities Litigation
Reform Act:
This news release contains forward-looking statements within the
meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995. These statements are based upon our
current expectations and speak only as of the date hereof. Our
actual results may differ materially and adversely from those
expressed in any forward-looking statements as a result of various
factors and uncertainties, including our ability to finance our
operations, the future success of our scientific studies, our
ability to successfully develop drug candidates, the timing for
starting and completing clinical trials, actions of the U.S. Food
and Drug Administration (FDA) and similar global regulatory bodies,
rapid technological change in our markets, and the enforcement of
our intellectual property rights. Arrowhead Research Corporation's
most recent Annual Report on Form 10-K and subsequent Quarterly
Reports on Form 10-Q discuss some of the important risk factors
that may affect our business, results of operations and financial
condition. We assume no obligation to update or revise
forward-looking statements to reflect new events or
circumstances.
Source: Arrowhead Research Corporation
Arrowhead Research CorporationVince Anzalone, CFA,
626-304-3400ir@arrowres.comorInvestor Relations:The Trout
GroupLauren Glaser, 646-378-2972ir@arrowres.comorMedia:Russo
PartnersMartina Schwarzkopf, Ph.D.,
212-845-4292martina.schwarzkopf@russopartnersllc.com
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