RXi Pharmaceuticals Licenses Novel, Targeted Cancer Vaccine for Gynecological Cancers

Wed Sep 21, 2011 7:19am EDT

* Reuters is not responsible for the content in this press release.

  --  Vaccine targets Folate Binding Protein (FBP) which is over-expressed in
      more than 90% of ovarian cancers and in the majority of other
  --  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(TM) (E75),
      scheduled to commence its Phase 3 PRESENT study in breast cancer in 1H

WORCESTER, Mass., Sept. 21, 2011 (GLOBE NEWSWIRE) -- 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

"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,

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(TM) (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(TM) 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(R) (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, 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,

The RXi Pharmaceuticals Corporation logo is available at

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


          Remy Bernarda
          IR Sense, LLC

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