Galectin Therapeutics Announces Initiation of Phase 1/2 Trial of Novel Combination Therapy for Advanced Metastatic Melanoma

  Galectin Therapeutics Announces Initiation of Phase 1/2 Trial of Novel
  Combination Therapy for Advanced Metastatic Melanoma

Business Wire

NEWTON, Mass. -- 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

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.


Galectin Therapeutics Inc.
Maureen Foley, 617-559-0033
Chief Operating Officer
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