PASADENA, Calif.--(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.
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please visit http://ir.arrowheadresearch.com/alerts.cfm.
Source: Arrowhead Research Corporation
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http://ir.arrowheadresearch.com/releasedetail.cfm?ReleaseID=890676Labels: ARC-520 Phase 2b Study Update