Aravive Announces Independent Data Monitoring Committee Recommends Continuation of Phase Ib Study of AVB-500 In Recurrent Pla...
July 08 2019 - 7:05AM
Aravive, Inc. (Aravive) (NASDAQ:ARAV), a clinical-stage
biopharmaceutical company, announced that the independent Data
Monitoring Committtee (DMC) has reviewed the open-label data
following the first 28-day treatment cycle for the first six
patients in each of the two cohorts of the Phase 1b portion of the
Phase 1b/Phase 2 trial of AVB-500 in patients with
platinum-resistant recurrent ovarian cancer. The DMC did not
identify safety concerns with AVB-500 (previously called
AVB-S6-500). Importantly, data demonstrated suppression of serum
GAS6 levels, a biomarker associated with efficacy in preclinical
tumor models, with the current dose. The dosing regimen was
predicted by the Phase 1 healthy volunteer study. The DMC
unanimously recommended the study continue as planned and enroll
additional patients into each cohort to collect additional
preliminary efficacy, safety, biomarker and PK/PD data at the
current dose. The company remains on track to report interim
safety, pharmacodynamic, and pharmacokinetic data for the phase 1b
portion in the third quarter of 2019.
“We are pleased that the safety profile of AVB-500 continues to
be favorable, and are encouraged with the first demonstration of
proof of mechanism in cancer patients as shown by suppression of
circulating free GAS6 during the dosing interval,” said Jay
Shepard, CEO of Aravive.
About Platinum-resistant, Recurrent
Epithelial Ovarian CancerIn the United States, ovarian
cancer ranks fifth in cancer deaths among women, accounting for
more deaths than any other cancer of the female reproductive
system. Each year in the United States, over 22,000 women develop
ovarian cancer and there are approximately 14,240 attributed deaths
annually.
About the Phase Ib/Phase 2 Recurrent
Platinum Resistant Ovarian Cancer Trial The open label
Phase 1b safety lead-in portion of the efficacy and safety study of
AVB-500 in patients with platinum-resistant recurrent ovarian
cancer is enrolling patients into two cohorts, one investigating a
combination of AVB-500 with pegylated liposomal doxorubicin, and
the other, a combination of AVB-500 with paclitaxel. The primary
objectives are to assess safety and tolerability of the
combinations and to confirm the dose based on results from the
healthy volunteer clinical trial of AVB-500 (NCT03401528). The
clinical trial will also explore secondary endpoints including
preliminary activity measures and effects on biomarkers (GAS6-AXL)
in serum and tumor tissues. The trial is listed on
clinicaltrials.gov NCT03639246.
About AVB-500AVB-500 (previously called
AVB-S6-500) is a therapeutic recombinant fusion protein that has
been shown to neutralize GAS6 activity by binding to GAS6 with very
high affinity. In doing so, AVB-500 selectively inhibits the
GAS6-AXL signaling pathway. In preclinical studies, GAS6-AXL
inhibition has shown anti-tumor activity, both as a single agent or
in combination with a variety of anticancer therapies including
radiation therapy, immuno-oncology agents, and chemotherapeutic
drugs that affect DNA replication and repair. Increased expression
of AXL and GAS6 in tumors are correlated to poor prognosis and
survival and has been implicated in therapeutic resistance to
conventional chemotherapeutics and targeted therapies.
A Phase 1 clinical trial in healthy volunteers (NCT03401528)
investigating the safety, pharmacokinetics, and pharmacodynamics
was completed last year. The study met the safety and tolerability
endpoints and demonstrated clinical proof-of-mechanism for AVB-500
in neutralizing GAS6.
About AraviveAravive, Inc. (Nasdaq: ARAV) is a
clinical-stage biopharmaceutical company developing treatments
designed to halt the progression of life-threatening diseases,
including cancer and fibrosis. Aravive’s lead product candidate,
AVB-500, is an ultra-high affinity decoy protein that targets the
GAS6-AXL signaling pathway. By capturing serum GAS6, AVB-500
starves the AXL pathway of its signal, potentially halting the
biological programming that promotes disease progression. AXL
receptor signaling plays an important role in multiple types of
malignancies by promoting metastasis, cancer cell survival,
resistance to treatments, and immune suppression. The GAS6-AXL
signaling pathway also plays a significant role in fibrogenesis.
Aravive has initiated the phase 1b portion of a phase 1b/2 clinical
trial of AVB-500 combined with standard of care therapies in
patients with platinum-resistant ovarian cancer, and intends to
expand development into additional oncology and fibrotic
indications. For more information, please visit
www.aravive.com.
Forward Looking Statements This communication
contains forward-looking statements (including within the meaning
of Section 21E of the United States Securities Exchange Act of
1934, as amended, and Section 27A of the United States Securities
Act of 1933, as amended), express or implied, concerning the
Company's goals, intentions and expectations as to future plans or
events, including statements regarding remaining on track to report
interim safety, pharmacodynamic, and pharmacokinetic data for the
phase 1b portion in the third quarter of 2019, the potential of
AVB-500 to halt the biological programming that promotes disease
progression and expanding development into additional oncology and
fibrosis indications. Forward-looking statements are based on
current beliefs and assumptions, are not guarantees of future
performance and are subject to risks and uncertainties that could
cause actual results to differ materially from those contained in
any forward-looking statement as a result of various factors,
including, but not limited to, risks and uncertainties related to:
the Company’s ability to expand development in 2019 into additional
oncology and fibrotic indications, the Company’s dependence upon
AVB-500, AVB-500’s ability to have favorable results in clinical
trials, including continuing to have a favorable safety profile or
receive regulatory approval, potential delays in the Company's
clinical trials due to regulatory requirements or difficulty
identifying qualified investigators or enrolling patients; the risk
that AVB-500 may cause serious side effects or have properties that
delay or prevent regulatory approval or limit its commercial
potential; the risk that the Company may encounter difficulties in
manufacturing AVB-500; if AVB-500 is approved, risks associated
with its market acceptance, including pricing and reimbursement;
potential difficulties enforcing the Company's intellectual
property rights; the Company's reliance on its licensor of
intellectual property and financing needs. The foregoing review of
important factors that could cause actual events to differ from
expectations should not be construed as exhaustive and should be
read in conjunction with statements that are included herein and
elsewhere, including the risk factors included in the Company's
Annual Report on Form 10-K and Form 10-K/A for the fiscal year
ended December 31, 2018, recent Current Reports on Form 8-K and
subsequent filings with the SEC. Except as required by applicable
law, the Company undertakes no obligation to revise or update any
forward-looking statement, or to make any other forward-looking
statements, whether as a result of new information, future events
or otherwise.
Contacts:
Investors: Mike Zanoni Endurance Advisors
mzanoni@enduranceadvisors.com 610-442-8570
Media: Heidi Chokeir Canale Communications heidi@canalecomm.com
619-849-5377
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