Combination Immunotherapy with Galectin-3 Inhibitor GR-MD-02 Enhances Effects in Pre-clinical Models and Early Results of Pha...
February 07 2017 - 4:40PM
Galectin Therapeutics Inc. (NASDAQ:GALT), the
leading developer of therapeutics that target galectin proteins,
and the Providence Cancer Center today announced the presentation
of preclinical and early clinical data from two
investigator-initiated Phase 1 clinical trials of GR-MD-02 used in
combination with approved cancer immunotherapies. Data presented
today at the 9th GTCBio Immunotherapeutics & Immunomonitoring
Conference in San Diego, CA by Dr. William L. Redmond, Providence
Cancer Center, has been posted.
“Preclinical results in mouse models of multiple types of
cancers showed important anti-tumor and increased survival effects
of combining GR-MD-02 with different types of immune modulators,
providing a compelling case for progressing studies into human
patients with cancer,” said William L. Redmond, Ph.D., Associate
Member, Laboratory of Cancer Immunotherapy, and Director, Immune
Monitoring Laboratory, Earle A. Chiles Research Institute,
Providence Cancer Center, Portland, OR. “We are pleased that our
translational medicine team is conducting two phase 1 clinical
trials which were initiated under the direction of principal
investigator Brendan D. Curti, M.D., Director of the Providence
Biotherapy Program at Providence Cancer Center.”
GR-MD-02 was combined with pembrolizumab (KEYTRUDA®) in patients
with advanced melanoma, and this study has been expanded to
patients with oral/head and neck cancer (OHN) and non small cell
lung cancer (NSCLC)
(https://clinicaltrials.gov/ct2/show/NCT02575404?term=GR-MD-02&rank=1).
Six subjects with advanced melanoma have been enrolled in the
lowest dose cohort (2 mg/kg) with no safety concerns related to
GR-MD-02. To date, one partial response and one mixed response has
been observed. Below is a chest CT scan of the patient with a
partial response showing a marked reduction in tumor size at week
12 of therapy, after 3 doses of combined GR-MD-02 and
pembrolizumab.
A photo accompanying this announcement is available
at http://www.globenewswire.com/NewsRoom/AttachmentNg/4f1c423b-c711-467b-83f6-8d90f0cfc191
GR-MD-02 was also combined with ipilimumab (Yervoy®) in patients
with advanced melanoma
(https://clinicaltrials.gov/ct2/show/NCT02117362?term=GR-MD-02&rank=6).
Seven subjects treated with the lowest two dose cohorts of GR-MD-02
(1 and 2 mg/kg) have been completed with no safety signals
identified due to GR-MD-02. In these low dose initial cohorts,
there were no notable changes in the peripheral immune signature.
Due to changes in the standard of care for metastatic melanoma
(i.e., approval of KEYTRUDA®), recruitment has been slowed
significantly.
“We are encouraged by these early safety results and look
forward to further data on the safety and efficacy of GR-MD-02 used
in combination with pembrolizumab (KEYTRUDA®) in patients with
metastatic melanoma, OHN, or NSCLC,” said Dr. Curti. “While we
cannot conclude from the one partial response in the pembrolizumab
study that the response was related to GR-MD-02, it provides us
with a clinically relevant signal to follow as GR-MD-02 doses are
escalated. We hope to report additional data in early 2018
when we anticipate a decision on progressing to phase 2. This
decision will be based on the response rate of the combination of
pembrolizumab with GR-MD-02 as compared to historical response
rates to pembrolizumab alone.”
About GR-MD-02GR-MD-02 is a complex
carbohydrate drug that targets galectin-3, a critical protein in
the pathogenesis of fatty liver disease and fibrosis. Galectin-3
plays a major role in diseases that involve scarring of organs
including fibrotic disorders of the liver, lung, kidney, heart and
vascular system. The drug binds to galectin proteins and disrupts
their function. Preclinical data in animals have shown that
GR-MD-02 has robust treatment effects in reversing liver fibrosis
and cirrhosis.
About Galectin TherapeuticsGalectin
Therapeutics is developing promising carbohydrate-based therapies
for the treatment of fibrotic liver disease, skin disease and
cancer based on the Company's unique understanding of galectin
proteins, which are key mediators of biologic function. Galectin
seeks to leverage extensive scientific and development expertise as
well as established relationships with external sources to achieve
cost-effective and efficient development. The Company is pursuing a
development pathway to clinical enhancement and commercialization
for its lead compounds in liver fibrosis and cancer. Additional
information is available at www.galectintherapeutics.com.
About Robert W. Franz Cancer Research Center, Earle A.
Chiles Research Institute (EACRI), Providence Cancer Center,
Providence Portland Medical Center, Portland
OregonProvidence Cancer Center, a part of Providence
Health & Services, offers the latest in cancer services,
including diagnostic, treatment, prevention, education, support and
internationally renowned research. The Robert W. Franz Cancer
Research Center in the Earle A. Chiles Research Institute is a
world-class research facility located within Providence Cancer
Center. The Institute's main area of investigation is cancer
immunotherapy, a specialized field of study focused on triggering
the immune system to fight cancer. Visit
www.chilesresearch.org.
Forward Looking StatementsThis press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements relate
to future events, and use words such as “may,” “estimate,” “could,”
“expect” and others. They are based on current expectations and are
subject to factors and uncertainties that could cause actual
results to differ materially from those described in the
statements. These statements include those regarding the hope that
Galectin’s development program for GR-MD-02 will lead to a therapy
for the treatment of fibrotic liver disease and/or an additional
therapy for the treatment of cancer when used in combination
with pembrolizumab. Factors that could cause actual
performance to differ materially from those discussed in the
forward-looking statements include, among others, that Galectin may
not be successful in developing effective treatments and/or
obtaining the requisite approvals for the use of GR-MD-02 or any of
its other drugs in development. Current clinical trial and any
future clinical studies may not produce positive results in a
timely fashion, if at all, and could prove time consuming and
costly. Plans regarding development, approval and
marketing of any of Galectin’s drugs are subject to change at any
time based on the changing needs of the Company as determined by
management and regulatory agencies. Regardless of the results of
any of its development programs, Galectin may be unsuccessful in
developing partnerships with other companies or raising additional
capital that would allow it to complete its current trials or
further develop and/or fund further studies or trials. Galectin has
incurred operating losses since inception, and its ability to
successfully develop and market drugs may be impacted by its
ability to manage costs and finance continuing operations. For a
discussion of additional factors impacting Galectin’s business, see
the Company’s Annual Report on Form 10-K for the year ended
December 31, 2015, and subsequent filings with the SEC. You should
not place undue reliance on forward-looking statements. Although
subsequent events may cause its views to change, management
disclaims any obligation to update forward-looking statements.
Galectin Therapeutics Contact:
Jessica Stanek
GregoryFCA
jessicas@gregoryfca.com
215-297-3606
Providence Cancer Center, Providence Portland Medical Center Contact:
Jean Powell Marks
503-215-6433
jean.marks@providence.org
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