RXi Pharmaceuticals Licenses Novel, Targeted Cancer Vaccine for Gynecological Cancers
September 21 2011 - 7:09AM
- Vaccine targets Folate Binding Protein (FBP) which is
over-expressed in more than 90% of ovarian cancers and in the
majority of other adenocarcinomas.
- RXi plans to initiate Phase 1 clinical trials of the
FBP vaccine by year-end 2011.
- License doubles RXi's oncology pipeline which includes
NeuVax™ (E75), scheduled to commence its Phase 3
PRESENT study in breast cancer in 1H 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, announced today that it licensed
worldwide rights to develop and commercialize a Folate Binding
Protein-E39 (FBP) targeted vaccine to prevent recurrence in
gynecological cancers such as ovarian and endometrial
adenocarcinomas. The FBP vaccine was licensed from The University
of Texas M D Anderson Cancer Center (MD Anderson) and Henry M.
Jackson Foundation for the Advancement of Military Medicine, Inc.
(HJF). FBP has been granted Investigational New Drug (IND) approval
by the U.S. Food and Drug Administration (FDA) to enter clinical
trials. Institutional Review Board (IRB) approval has also been
received allowing RXi to initiate Phase 1 trials by the end of
2011.
"Licensing FBP which is already IND- and IRB- approved, and
ready to commence two Phase 1 clinical trials in
ovarian/endometrial and breast cancers, doubles our pipeline and
further advances RXi's leadership in cancer immunotherapy," said
Mark J. Ahn, PhD, CEO and President of RXi
Pharmaceuticals. "We anticipate initiation of clinical trials
this year and are excited about exploring the promising potential
of the FBP vaccine in critical areas of unmet medical need."
The FBP vaccine consists of the E39 peptide combined with the
immune adjuvant granulocyte macrophage colony stimulating factor
(GM-CSF). FBP is over-expressed (20-80 fold) in more
than 90% of ovarian and aggressive endometrial cancers, as well as
20–50% of breast, lung, colorectal, and renal cell
carcinomas. FBP has very limited tissue distribution and
expression in non-malignant tissue and has many years of validation
as an ideal immunotherapy target.
"The broad overexpression of FBP in such a wide variety of
cancers suggests the exciting potential of a widely applicable
FBP-based vaccine in epithelial cancers," said COL George E
Peoples, MD, FACS, one of the inventors of the FBP patents and
Director, Cancer Vaccine Development Program; Deputy Director,
United States Military Cancer Institute (USMCI); Professor,
Surgery, Uniformed Services University of the Health and Sciences;
Chief Surgical Oncology, Brooke Army Medical Center (BAMC). USMCI
is a component of the Uniformed Services University of the Health
Sciences, an institution of higher learning within the Department
of Defense, an agency of the U.S. Government, located in Bethesda,
MD.
About Ovarian/Endometrial Cancers
Ovarian cancer occurs in over 22,000 patients per year in the
U.S. and is the most lethal gynecologic cancer. Despite the
incidence of ovarian cancer being only a small fraction of breast
cancer, the number of patients that die from ovarian cancer is
nearly 50% that of breast cancer. Due to the lack of specific
symptoms, the majority of ovarian cancer patients are still
diagnosed at later stages of the disease. These patients are
routinely surgically debulked to minimal residual disease, and then
treated with platinum- and/or taxane-based chemotherapy. While
most patients respond to this treatment regime and become
clinically free of disease, the majority of these patients will
relapse, and once the disease recurs, the treatment options and
successes drop dramatically.
Endometrial cancer is the most common gynecologic cancer and
occurs in over 43,000 women in the US annually. There are two
basic types of endometrial cancer: endometriod and papillary
serous. The latter has a much more aggressive clinical course
similar to ovarian cancer and the majority of these patients will
die of this form of the disease.
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 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 HER2 (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 Henry M. Jackson Foundation for the Advancement of
Military Medicine, Inc. (HJF)
HJF, located in Rockville, Maryland, is a private,
not-for-profit organization authorized by Congress to support
medical education and research at the Uniformed Services University
of the Health Sciences and throughout the military medical
community.
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,
visitwww.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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