Full Press Release Details
RXi Pharmaceuticals Strengthens NeuVax TM (E75) Patent Portfolio
| RXi acquires patent rights covering use of NeuVax in combination with trastuzumab (Herceptin ; Genentech/Roche); and use in low-to-intermediate HER2 breast cancer patients not eligible for Herceptin therapy. | |||
| NeuVax (E75) targeted to initiate the Phase 3 PRESENT ( P revention of R ecurrence in E arly- S tage, Node-Positive Breast Cancer with Low to Intermediate HER2 E xpression with N euVax T reatment) study in 1H, 2012 |
Worcester, MA, July 13, 2011 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 expanded its
patent portfolio with additional patents covering worldwide rights to develop and commercialize
NeuVax (E75). The patents licensed from The Henry M. Jackson Foundation for the Advancement of
Military Medicine, Inc. (HJF) cover the use of NeuVax in combination with trastuzumab (Herceptin ;
Genentech/Roche), and use in low-to-intermediate HER2 (Human Epidermal growth factor Receptor)
breast cancer patients not eligible for Herceptin therapy. These patents are added to the growing
family of patents for RXi to support the development of NeuVax in a variety of indications and
countries. NeuVax was discovered at The M. D. Anderson Cancer Center (MDACC) and licensed from
NeuVax consists of the E75 peptide derived from HER2 combined with the immune adjuvant granulocyte
macrophage-colony stimulating factor (GM-CSF). RXi recently reported Phase 2 results at the
American Society of Clinical Oncology (ASCO) annual meeting which showed NeuVax (E75), when
combined with trastuzumab in HER2 over-expressing patients, demonstrated 0% recurrence at 48
months, with an excellent safety and tolerability profile. Thus, combination of NeuVax and
trastuzumab represents a potential expansion of the market for NeuVax to HER2 3 breast cancer
patients in the adjuvant setting.
Strengthening the breadth and depth of our intellectual property portfolio is critical to building
value and the foundation of our NeuVax strategy, stated Mark J. Ahn, PhD, President and CEO. We
look forward to initiating the NeuVax Phase 3 clinical trial in breast cancer, which is targeted to
begin in the first half of 2012.
COL George E Peoples, MD, FACS, is the inventor of the two new patents and conducted the Phase 1
and Phase 2 clinical trials of NeuVax. Dr. Peoples is Director, Cancer Vaccine Development
Program; Deputy Director, United States Military Cancer Institute (USMCI); Professor, Surgery,
University of the Health Sciences; Chief, Surgical Oncology, Brooke Army Medical
Center (BAMC) and Professor (adjunct), Surgical Oncology, M. D. Anderson Cancer Center. 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,
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 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.
The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF)
HJF, located in Rockville, Maryland, is a private, not-for-profit organization chartered 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, visit www.rxipharma.com.
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
our and patent rights, our expectations, plans and prospects for the development of our products,
and milestones and royalties that could become payable in connection with our recent licenses.
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