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EX-10.1 - EX-10.1 - SELLAS Life Sciences Group, Inc. | b86058exv10w1.htm |
8-K - FORM 8-K - SELLAS Life Sciences Group, Inc. | b86058e8vk.htm |
EX-10.2 - EX-10.2 - SELLAS Life Sciences Group, Inc. | b86058exv10w2.htm |
Exhibit 99.1
RXi Pharmaceuticals Completes Apthera Acquisition
NeuVax is slated to commence Phase III clinical trials in low-to-intermediate HER2+ breast cancer
patients, not eligible for Herceptin®, in 1H 2012
patients, not eligible for Herceptin®, in 1H 2012
RXis first self-delivering RNAi product candidate, RXI-109 which targets CTGF (connective tissue
growth factor), scheduled to commence human clinical trials for anti-scarring in planned surgeries in
early 2012
growth factor), scheduled to commence human clinical trials for anti-scarring in planned surgeries in
early 2012
WORCESTER, Mass., April 14, 2011 (BUSINESS WIRE) RXi Pharmaceuticals
Corporation (Nasdaq: RXII), a biotechnology company focused on discovering,
developing and commercializing innovative therapies addressing major unmet
medical needs using RNA-targeted and immunotherapy technologies, today
announced the completion of its previously announced acquisition of Apthera,
Inc.
The acquisition provides RXi with a late stage product candidate, NeuVax, a
peptide-based immunotherapy for low-to-intermediate HER2+ breast cancer
patients who are not eligible for Herceptin®. RXi has targeted NeuVax to enter
Phase III clinical trials in the first half of 2012. The Companys first
self-delivering RNAi product, RXI-109 for anti-scarring in planned surgeries,
remains on track for an investigational new drug (IND) application filing this
year.
Under the terms of the acquisition agreement, Apthera stockholders will
initially receive approximately 4.8 million shares of RXis common stock.
Aptheras stockholders will also be entitled to contingent payments based on
the achievement of certain development and commercial milestones relating to
Aptheras NeuVax product candidate.
NeuVax and RXI-109 significantly advance RXi into a product development
company with novel therapeutics addressing large unmet medical needs, said
Mark J. Ahn, PhD, President and Chief Executive Officer of RXi Pharmaceuticals.
We believe we have the people, pipeline and resources to realize the promise
of our innovative products for patients and shareholders.
An audiocast presentation including an RXi corporate overview of the Apthera
acquisition and cancer immunotherapy treatment featuring Dr. Mark Ahn and
NeuVax developer Dr. George Peoples will be available from the Investor
Relations section of the Companys website,
www.rxipharma.com.
About NeuVax (E75)
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 II 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 a
Phase III clinical trial in adjuvant therapy of women with low-to-intermediate
HER2+ status.
According to the National Cancer Institute, over 200,000 women are diagnosed
with breast cancer annually in the US alone in 2010. 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+ breast cancer
patients 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, those who are HER2+ 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-109
RXi Pharmaceuticals has initiated development of clinical candidate RXI-109, a
self-delivering RNAi compound (sd-rxRNA) for the reduction of dermal scarring
in planned surgeries. RXI-109 is designed to reduce the expression of CTGF
(connective tissue growth factor) a critical regulator of several biological
pathways involved in fibrosis, including scar formation in the skin. RXi is
beginning manufacturing activities with an experienced cGMP oligonucleotide
manufacturer to support its IND enabling toxicology program, and is preparing a
pre-IND package for submission to the FDA. Pending FDA review, the company
intends to use an innovative clinical trial design to study safety and
tolerability as well as initial efficacy in its first clinical trial targeted
for 2012.
About RXi Pharmaceuticals Corporation
RXi Pharmaceuticals Corporation is a biotechnology company focused on
discovering, developing and commercializing innovative therapies addressing
major unmet medical needs using RNA-targeted and immunotherapy technologies.
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 the Apthera acquisition, future
expectations, plan and future development of RXis and Aptheras products and
technologies. These forward-looking statements about future expectations, plans
and prospects of the development of RXis and Aptheras products and
technologies involve significant risks, uncertainties and assumptions,
including the risk that the development of NeuVax or our RNAi-based
therapeutics may be delayed or may not proceed as planned and we may not be
able to complete development of any RNAi-based product, the risk that the
reduction in our early stage RNAi research and development activities may
adversely affect our ability to effectively develop our RNAi technologies, to
develop existing or new RNAi product candidates or to enter into or effectively
continue collaborations or strategic alliances in this field, the risk that the
FDA approval process may be delayed for any drugs that we develop, risks
related to development and commercialization of products by our competitors,
risks related to our ability to control the timing and terms of collaborations
with third parties and the possibility that other companies or organizations
may assert patent rights that prevent us from developing our products. Actual
results may differ materially from those RXi contemplated by these
forward-looking statements. RXi 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 release.
CONTACT:
RXi Pharmaceuticals
Tamara McGrillen, 508-929-3605
ir@rxipharma.com
RXi Pharmaceuticals
Tamara McGrillen, 508-929-3605
ir@rxipharma.com
or
Investors
S. A. Noonan Communications
Susan Noonan, 212-966-3650
susan@sanoonan.com
S. A. Noonan Communications
Susan Noonan, 212-966-3650
susan@sanoonan.com
or
Media
Rx Communications Group
Eric Goldman, 917-322-2563
egoldman@rxir.com
Rx Communications Group
Eric Goldman, 917-322-2563
egoldman@rxir.com