NEWTON, Mass.--(BUSINESS WIRE)--May. 15, 2012--
Galectin Therapeutics (NASDAQ: GALT) (“the Company”), the leader in
developing carbohydrate-based therapeutic compounds to inhibit galectin
proteins for the therapy of liver fibrosis and cancer, today announced
that the first patient has been dosed in a Phase 1/2 trial evaluating
the safety and efficacy of a novel treatment combination for the
treatment of advanced metastatic melanoma. The trial, being conducted in
collaboration with the Cancer Centre at the Cliniques universitaires
Saint-Luc and the Ludwig Institute for Cancer Research (LICR), is
evaluating Galectin Therapeutics’ carbohydrate-based galectin inhibitor
compound, GM-CT-01, in combination with a Ludwig Institute peptide
vaccine.
“This first-in-human Phase 1/2 study combines active vaccination and
immunomodulatory agents to enhance the immune system’s ability to kill
cancerous cells,” said Prof. Jean-François Baurain of the Cancer Center
at the Cliniques universitaires Saint-Luc, the principal investigator of
the trial. “The initiation of this trial is an important step in
evaluating a potential new treatment modality for patients with advanced
metastatic melanoma, who experience limited success with currently
available therapies.”
“Galectin Therapeutics is committed to realizing the promise of galectin
inhibition in cancer immunotherapy, and this trial of vaccine plus
galectin inhibitor in metastatic melanoma is a critical first step in
that effort,” commented Peter Traber, M.D., CEO of Galectin
Therapeutics. “We are honored to work with Dr. Baurain and the team at
the Ludwig Institute and look forward to progress in this study.”
In the Phase 1/2 study, patients will receive a peptide vaccine (either
MAGE-3.A1 or NA17.A2) injection at three-week intervals throughout the
study and GM-CT-01 intravenously every three days, beginning after the
third dose of the peptide vaccine. Patients with at least one
superficial metastatic lesion will also receive GM-CT-01 at the site of
the lesion. The primary endpoint is partial or complete response.
The Cliniques universitaires Saint-Luc and LICR are funding the first
stage of the trial, and the second stage will be funded through grants
and/or Galectin Therapeutics funds.
About the Phase 1/2 Trial
Patients enrolled in the trial will have metastatic melanoma with
regional or distant metastatic disease with either HLA-A1 type and
MAGE-3 or HLA-A2 type and NA17.A2 expressed by the tumor. Patients will
be divided in two treatment arms that will be run in parallel. Patients
with at least one measurable lesion will be assigned to group 1 and will
receive peptide vaccinations and systemic GM-CT-01 injections. Patients
with at least one measurable and at least one superficial metastasis
will be assigned in priority to group 2 and will receive peptide
vaccinations, systemic GM-CT-01 administrations and peri-tumoral
administration of GM-CT-01. The vaccine matching the patient’s HLA type
and the gene expression of the patient’s tumor (if both antigens are
expressed the patient will receive both peptides) will be administered
subcutaneously every three weeks on six occasions. GM-CT-01 will be
administered every three days after each of the third through sixth
vaccination and, in those patients with superficial metastases,
additionally by peri-tumoral injection on the same schedule. In Stage 1,
six patients will be enrolled in each arm. If no CR or PR is observed,
the trial will be stopped, otherwise, an additional 17 patients will be
enrolled in Stage 2. Tumor staging will be performed before inclusion
and after treatment. Immunological analysis will be performed on
T-lymphocytes prior to treatment and after two and six vaccinations.
Primary endpoints include safety and tumor response according to
Response Evaluation Criteria in Solid Tumors (RECIST 1.1) guidelines.
Secondary endpoints will include overall survival and immunological
measurements. Results of Stage 1 are expected within one year.
About Galectin Therapeutics
Galectin Therapeutics (NASDAQ: GALT) is developing promising
carbohydrate-based therapies for fibrotic liver disease and cancer based
on the Company's unique understanding of galectin proteins, key
mediators of biologic function. We are leveraging extensive scientific
and development expertise as well as established relationships with
external sources to achieve cost effective and efficient development. We
are pursuing a clear development pathway to clinical enhancement and
commercialization for our lead compounds in liver fibrosis and cancer.
Additional information is available at http://www.galectintherapeutics.com.
Forward Looking Statements
This press release contains, in addition to historical information,
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements relate to future events
or future financial performance, and use words such as “may,”
“estimate,” “could,” “expect” and others. They are based on our current
expectations and are subject to factors and uncertainties which could
cause actual results to differ materially from those described in the
statements. Factors that could cause our actual performance to differ
materially from those discussed in the forward-looking statements
include, among others: incurrence of operating losses since our
inception, uncertainty as to adequate financing of our operations,
extensive and costly regulatory oversight that could restrict or prevent
product commercialization, inability to achieve commercial product
acceptance, inability to protect our intellectual property, dependence
on strategic partnerships, product competition, and others stated in
risk factors contained in our SEC filings. We cannot assure that we have
identified all risks or that others may emerge which we do not
anticipate. You should not place undue reliance on forward-looking
statements. Although subsequent events may cause our views to change, we
disclaim any obligation to update forward-looking statements.
Source: Galectin Therapeutics
Galectin Therapeutics Inc.
Maureen Foley, 617-559-0033
Chief
Operating Officer
foley@galectintherapeutics.com
