RXi Pharmaceuticals Provides Positive NeuVax(TM) Phase 3 Clinical Trial Update
September 12 2011 - 7:05AM
- The CMC partial clinical hold has been lifted by the
FDA, allowing the pivotal Phase 3 trial to commence.
- RXi has assigned a principal investigator and initial
IRB approvals received--going to 100 trial sites
in the US, Canada, and Europe.
- CRO Aptiv Solutions has been engaged and international
trial operations are underway for the initiation of the
Phase 3 PRESENT study in the first half of
2012.
RXi Pharmaceuticals Corporation (Nasdaq:RXII), a biotechnology
company focused on discovering, developing and commercializing
innovative therapies addressing major unmet medical needs using
targeted biotherapeutics, today announced a clinical trial update
on its lead program, NeuVax™ (E75 peptide vaccine with GM-CSF
adjuvant), a cancer immunotherapy targeted for low-to-intermediate
HER2 expressing breast cancer patients not eligible for trastuzamab
(Herceptin®). RXi received official notification from the U.S. Food
and Drug Administration (FDA) that the Chemistry, Manufacturing,
and Controls (CMC) partial clinical hold has been lifted. RXi has
satisfied all requirements specified by the FDA and has initiated a
clinical trial material manufacturing plan to remain on schedule to
meet the planned trial start date. NeuVax is expected to initiate
its Phase 3 PRESENT (Prevention of Recurrence in Early-Stage,
Node-Positive Breast Cancer with Low to Intermediate HER2
Expression with NeuVax™ Treatment) study in the first half of 2012
under a Special Protocol Assessment (SPA).
RXi has made other significant developments in preparation for
the Phase 3 trial initiation:
- Dr. Beth Mittendorf, Assistant Professor, Department of
Surgical Oncology, University of Texas M. D. Anderson Cancer Center
has been selected as a principal investigator for the trial. Dr.
Mittendorf has been involved in cancer vaccine research for over 10
years, has lead numerous investigator sponsored studies, and has
published extensively in the area of breast cancer
immunotherapy.
- Conditional Institutional Review Board (IRB) approval from two
key trial sites has been received to allow for initiation of the
trial, with additional worldwide sites expected to open shortly. It
is anticipated that the trial will encompass approximately 100
trial sites in the U.S., Canada, and Europe.
- RXi has engaged the Clinical Research Organization (CRO) Aptiv
Solutions to manage the trial and clinical operations are on track
for PRESENT to commence in the first half of next year.
"Our extensive progress to date, including the timely lifting of
the clinical hold and significant headway with site IRBs, is
testament to the team's operational excellence and its commitment
to meeting program timelines," said Mark J. Ahn, President and CEO
of RXi. "NeuVax is now the cornerstone for building a strong
oncology pipeline as we continue to build momentum within the
oncology community and look forward to presenting additional NeuVax
data at key clinical meetings this Fall."
About NeuVax™ (E75)
RXi is also pursuing development of a cancer vaccine for breast
cancer. NeuVax consists of the E75 peptide derived from HER2
combined with the immune adjuvant granulocyte macrophage colony
stimulating factor (GM-CSF). Treatment with NeuVax stimulates
cytotoxic (CD8+) T cells in a highly specific manner to target
cells expressing any level of HER2. NeuVax is given as an
intradermal injection once a month for six months, followed by a
booster injection once every six months. Based on a successful
Phase 2 trial, which achieved its primary endpoint of disease free
survival (DFS), the Food and Drug Administration (FDA) granted
NeuVax a Special Protocol Assessment (SPA) for its Phase 3 PRESENT
(Prevention of Recurrence in Early-Stage, Node-Positive Breast
Cancer with Low to Intermediate HER2 Expression with NeuVax™
Treatment) study. The Phase 3 trial is expected to commence in
the first half of 2012.
According to the National Cancer Institute, over 200,000 women
in the U.S. are diagnosed with breast cancer annually. Of
these women, about 75% test positive for Human Epidermal growth
factor Receptor 2 (IHC 1+, 2+ or 3+). Only 25% of all breast
cancer patients, those with HER2 3+ disease are eligible for
Herceptin® (trastuzumab; Roche-Genentech) which had revenues of
over $5 billion in 2010. NeuVax targets the remaining 50% of
HER2 positive patients (HER2 1+ and 2+) who achieve remission with
current standard of care, but have no available HER2 targeted
adjuvant treatment options to maintain their disease free
status.
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation (Nasdaq:RXII) is a biotechnology
company focused on discovering, developing and commercializing
innovative therapies addressing major unmet medical needs using
targeted biotherapeutics. For more information, visit
www.rxipharma.com.
The RXi Pharmaceuticals Corporation logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=10128
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Such statements include, but are not limited to, statements
about the future expectations, plans and prospects of the
development of RXi Pharmaceuticals Corporation's products. These
forward-looking statements about future expectations, plans and
prospects of the development of the Company's products are subject
to a number of risks, uncertainties and assumptions, including
those identified under "Risk Factors" in the Company's most
recently filed Annual Report on Form 10-K, Quarterly Report on Form
10-Q and in other filings the Company periodically makes with the
SEC. Actual results may differ materially from those contemplated
by these forward-looking statements. The Company does not undertake
to update any of these forward-looking statements to reflect a
change in its views or events or circumstances that occur after the
date of this presentation.
CONTACT: RXi Pharmaceuticals
Tamara McGrillen
508-929-3615
ir@rxipharma.com
or
Remy Bernarda
IR Sense, LLC
415-203-6386
remy@irsense.com
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