EpiCept Announces New Crolibulin Data Presented at ASCO 2013 Support Further Evaluation in Anaplastic Thyroid Cancer


TARRYTOWN, N.Y.--(BUSINESS WIRE (http://www.businesswire.com/))-- Regulatory
News:

EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today announced that
new data supporting further evaluation of crolibulin were presented at the
Annual Meeting of the American Society of Clinical Oncology (ASCO 2013), taking
place May 31 to June 4, 2013 at the McCormick Place Convention Center in
Chicago. Crolibulin is EpiCept’s small molecule vascular disruption agent (VDA)
and apoptosis inducer for the treatment of patients with advanced solid tumors
and lymphomas. Crolibulin is a microtubule destabilizing agent that disrupts
vascular endothelial cells, and in turn, blood flow to tumors.

Presentation details are as follows:

Abstract #6074 – Head and Neck Cancer Session, Saturday, June 1, 2013, 8:00am
-11:45am

Title: "Phase I/II trial of crolibulin and cisplatin in solid tumors with a
focus on anaplastic thyroid cancer: Phase I results”

Authors: “Ann Wild Gramza, Sanjeeve Balasubramaniam, Antonio Tito Fojo, Jean
Ward, Samuel A. Wells; National Cancer Institute, National Institutes of Health,
Bethesda, MD

Preclinical studies showed synergism of crolibulin (CRO) associated with
cisplatin (CIS). The authors of the poster reported the Phase I portion of the
study designed to assess the safety and tolerance of CRO and CIS in patients
with solid tumors. Twenty-one patients were enrolled and received CIS and CRO up
to 100/20mg/m2of CIS/CRO.

Diagnoses were as follows: anaplastic thyroid cancer (16), urethelial carcinoma
(2), prostate carcinoma (2) and mesothelioma (1). The most common grade 3
toxicities were lymphopenia (33%), hypertension during infusion (29%),
hyponatremia (24%), anemia (19%) and hypophosphatemia (10%).

The authors concluded that the combination of CIS plus CRO shows interesting
results and deserves further evaluation as a regimen for anaplastic thyroid
cancer. The Maximum Tolerated Dose of CIS/CRO is 100mg/m2IV day 1 and 20mg/m2IV
days 1, 2, 3 every 21 days. This combination is well tolerated, with toxicity
primarily related to CIS. The Phase II portion of this trial will compare
CIS/CRO versus CIS alone in anaplastic thyroid cancer.

Stephane Allard, M.D., Chief Medical Officer of EpiCept, commented, “The results
of this study further expand the body of clinical data showing the clinical
promise for crolibulin in solid tumors. We are encouraged by these results.
EpiCept very shortly will initiate the Phase II portion of this trial in
collaboration with the National Cancer Institute.”

About Crolibulin

Crolibulin has demonstrated potent anti-tumor activity in both preclinical and
early clinical studies. In preclinical in vitro and in vivo studies, crolibulin
has been shown to induce tumor cell apoptosis and selectively inhibit growth of
proliferating cell lines, including multi-drug resistant cell lines. In April
2008 EpiCept announced positive clinical data from a Phase I study of crolibulin
in patients with solid tumors. In the future, crolibulin could be integrated
into Immune Pharmaceuticals’ NanomAbs® technology, antibody nanoparticle
conjugate technology developed by Prof. Shimon Benita of the Hebrew University
of Jerusalem.

About EpiCept Corporation

EpiCept is focused on the development and commercialization of pharmaceutical
products for the treatment of pain and cancer. The Company's pain portfolio
includes AmiKet™, a prescription topical analgesic cream in late-stage clinical
development designed to provide effective long-term relief of pain associated
with peripheral neuropathies. The Company's product Ceplene®, when used
concomitantly with low-dose IL-2 is intended as remission maintenance therapy in
the treatment of AML for adult patients who are in their first complete
remission. The Company sold all of its rights to Ceplene®in Europe and certain
Pacific Rim countries and a portion of its remaining Ceplene®inventory to Meda
AB in June 2012. The Company has other oncology drug candidates in clinical
development that were discovered using in-house technology and have been shown
to act as vascular disruption agents in a variety of solid tumors. In November
2012 EpiCept and Immune Pharmaceuticals Ltd., a privately held Israeli company,
entered into a definitive merger agreement. The transaction, as amended, is
anticipated to close during the third quarter of 2013 and is subject to
satisfaction of certain customary closing conditions, including approval by a
majority of EpiCept shareholders. The combined company will be focused on
developing antibody therapeutics and other targeted drugs for the treatment of
inflammatory diseases and cancer.

About Immune Pharmaceuticals Ltd.

Immune Pharmaceuticals Ltd. is an Israel and U.S.-based biopharmaceutical
company focused on the development of next-generation antibody therapeutics to
address unmet medical needs in the treatment of inflammatory diseases and
cancer. Immune licensed worldwide rights for systemic indications of
bertilimumab from iCo Therapeutics (TSX: ICO) in June 2011, while iCo retained
rights to all ophthalmic indications. iCo originally licensed exclusive
worldwide rights to bertilimumab in 2006 from MedImmune Limited (formerly known
as Cambridge Antibody Technology Limited), the global biologics unit of
AstraZeneca. Additionally, Immune has licensed from Yissum, the Technology
Transfer Company of the Hebrew University of Jerusalem, injectable applications
of the antibody nanoparticle conjugate technology (NanomAbs®) developed by Prof.
Shimon Benita. For more information, visit the Immune website at
www.immunepharmaceuticals.com (http://cts.businesswire.com/ct/CT?id=smartlink&ur
l 
=http%3A%2F%2Fwww.immunepharmaceuticals.com&esheet=50644506&lan=en
-US&anchor=www.immunepharmaceuticals.com&index=1&md5=47e962dafaea380815524521913
2 
6497).

Additional Information

In connection with the proposed merger transaction, EpiCept has filed a
preliminary proxy statement with the U.S. Securities and Exchange Commission
(SEC) and will file a definitive proxy statement with the SEC seeking
appropriate stockholder approval. STOCKHOLDERS OF EPICEPT AND OTHER INVESTORS
ARE URGED TO READ THE PRELIMINARY PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR
SUPPLEMENTS TO THE PRELIMINARY PROXY STATEMENT), WHICH IS AVAILABLE NOW, AND THE
DEFINITIVE PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS TO THE
DEFINITIVE PROXY STATEMENT) WHEN IT BECOMES AVAILABLE, REGARDING THE PROPOSED
TRANSACTION BECAUSE IT CONTAINS AND WILL CONTAIN IMPORTANT INFORMATION.
EpiCept's stockholders can obtain a copy of the preliminary proxy statement, and
will be able to obtain a copy of the definitive proxy statement when it becomes
available, as well as other filings containing information about Immune and
EpiCept, without charge, at the SEC's Internet site
(www.sec.gov (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fww
w 
.sec.gov&esheet=50644506&lan=en
-US&anchor=www.sec.gov&index=2&md5=e4d94f5998891af9ed8d270fd863eadb)). Copies of
the preliminary proxy statement, and the definitive proxy statement when it
becomes available, and any filings with the SEC that are incorporated by
reference in the proxy statement can also be obtained, without charge, by
directing a request to EpiCept Corporation, 777 Old Saw Mill River Rd,
Tarrytown, NY 10591, Attention: Investor Relations, Telephone: (914) 606-3500.

Participants in the Solicitation

EpiCept and its directors and executive officers and Immune and its directors
and executive officers may be deemed to be participants in the solicitation of
proxies from the stockholders of EpiCept in connection with the proposed
transaction. Computer Share AB will assist EpiCept in soliciting proxies from
Swedish stockholders. Information regarding the direct and indirect interests of
these directors and executive officers and Computer Share AB in EpiCept, Immune
and the merger transaction is included in the preliminary proxy statement, and
will be included in the definitive proxy statement when it becomes available, of
EpiCept referred to above. Additional information regarding the directors and
executive officers of EpiCept is also included in EpiCept's Annual Report on
Form 10-K for the fiscal year ended December 31, 2012, which was filed with the
SEC on March 5, 2013. This document is available free of charge at the SEC's web
site
(www.sec.gov (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fww
w 
.sec.gov&esheet=50644506&lan=en
-US&anchor=www.sec.gov&index=3&md5=619472d2d17cdff4c6d691493a2a26b1)) and from
Investor Relations at EpiCept at the address described above.

This communication shall not constitute an offer to sell or the solicitation of
an offer to buy any securities, nor shall there be any sale of securities in any
jurisdiction in which such offer, solicitation or sale would be unlawful prior
to registration or qualification under the securities laws of any such
jurisdiction. No offering of securities shall be made except by means of a
prospectus meeting the requirements of Section 10 of the Securities Act of 1933,
as amended (the "Act"). The securities issued in exchange for all of the
outstanding shares of Immune will not be and have not been registered under the
Act and may not be offered or sold in the United States absent registration or
an applicable exception from registration requirements.

The merger agreement and any accompanying issuance of shares by Immune
Pharmaceuticals are not, under any circumstances, to be construed as an
advertisement or a public offering of securities in Israel. Any public offer or
sale of securities in Israel may be made only in accordance with the Israeli
Securities Act-1968 (which requires, inter alia, the filing of a prospectus in
Israel or an exemption therefrom).

Forward-Looking Statements

This news release and any oral statements made with respect to the information
contained in this news release contain forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. You are urged
to consider statements that include the words “may,” “will,” “would,” “could,”
“should,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,”
“anticipates,” “intends,” “continues,” “forecast,” “designed,” “goal” or the
negative of those words or other comparable words to be uncertain and forward
-looking. Such forward-looking statements include statements that express plans,
anticipation, intent, contingency, goals, targets, future development and are
otherwise not statements of historical fact. These statements are based on our
current expectations and are subject to risks and uncertainties that could cause
actual results or developments to be materially different from historical
results or from any future results expressed or implied by such forward-looking
statements. Factors that may cause actual results or developments to differ
materially include: the risk that we may be unable to complete the proposed
merger transaction with Immune Pharmaceuticals; the risks associated with the
adequacy of our existing cash resources and our ability to continue as a going
concern; the risks associated with our ability to continue to meet our
obligations under our existing debt agreements; the risk that clinical trials
for AmiKet™ or crolibulin™ will not be successful; the risk that AmiKet™,
Azixa®or crolibulin™ will not receive regulatory approval or achieve significant
commercial success; the risk that we will not be able to find a partner to help
conduct the Phase III trials for AmiKet™ on attractive terms, a timely basis or
at all; the risk that Ceplene®will not receive regulatory approval or marketing
authorization in the United States or Canada; the risk that Ceplene® will not
achieve significant commercial success; the risk that our other product
candidates that appeared promising in early research and clinical trials do not
demonstrate safety and/or efficacy in larger-scale or later-stage clinical
trials; the risk that we will not obtain approval to market any of our product
candidates; the risks associated with dependence upon key personnel; the risks
associated with reliance on collaborative partners and others for further
clinical trials, development, manufacturing and commercialization of our product
candidates; the cost, delays and uncertainties associated with our scientific
research, product development, clinical trials and regulatory approval process;
our history of operating losses since our inception; the highly competitive
nature of our business; risks associated with litigation; and risks associated
with our ability to protect our intellectual property. These factors and other
material risks are more fully discussed in our periodic reports, including our
reports on Forms 8-K, 10-Q and 10-K and other filings with the U.S. Securities
and Exchange Commission. You are urged to carefully review and consider the
disclosures found in our filings which are available at
www.sec.gov (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fus.
l 
rd.yahoo.com%2F_ylt%3DAgfqFPfVOEK5M4_Rv8aJvhTjba9_%3B_ylu%3DX3oDMTEzM2pvaWgxBHBv
c 
wMyBHNlYwNuZXdzYXJ0Ym9keQRzbGsDd3d3c2VjZ292%2FSIG%3D15t064n6f%2F**http%253A%2Fct
s 
.businesswire.com%2Fct%2FCT%253Fid%3Dsmartlink%2526url%3Dhttp%25253A%25252F%2525
2 
Fwww.sec.gov%2526esheet%3D6170045%2526lan%3Den_US%2526anchor%3Dwww.sec.gov%2526i
n 
dex%3D2%2526md5%3D61ec7b72044301e411e3335754ee5c07&esheet=50644506&lan=en
-US&anchor=www.sec.gov&index=4&md5=40a831f5f8c86bdec16cd24b13a4fb2e) or at
www.epicept.com (http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2
F 
us.lrd.yahoo.com%2F_ylt%3DAhBuoawHw6iS3RhJOH9dNNfjba9_%3B_ylu%3DX3oDMTE2OGhhcWs4
B 
HBvcwMzBHNlYwNuZXdzYXJ0Ym9keQRzbGsDd3d3ZXBpY2VwdGNv%2FSIG%3D1659oglun%2F**http%2
5 
3A%2Fcts.businesswire.com%2Fct%2FCT%253Fid%3Dsmartlink%2526url%3Dhttp%25253A%252
5 
2F%25252Fwww.epicept.com%2526esheet%3D6170045%2526lan%3Den_US%2526anchor%3Dwww.e
p 
icept.com%2526index%3D3%2526md5%3D8b3a48c3367e26fcfbd15295b6d82118&esheet=506445
0 
6&lan=en
-US&anchor=www.epicept.com&index=5&md5=a9e9d79ed32f9de4aff6ea35974dc587). You
are cautioned not to place undue reliance on any forward-looking statements, any
of which could turn out to be wrong due to inaccurate assumptions, unknown risks
or uncertainties or other risk factors.
EpiCept Corporation:
Robert W. Cook, 914-606-3500
rcook@epicept.com
or
Media:
Feinstein Kean Healthcare
Greg Kelley, 617-577-8110
gregory.kelley@fkhealth.com
or
Investors:
LHA
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
or
Bruce Voss, 310-691-7100
bvoss@lhai.com

Attachments

06038119.pdf