Pipeline updates are highly awaited events in the
pharma/biotech sector as they play an important role in deciding
whether or not to invest in a particular company. Pipelines are
of prime importance as far as pharma/biotech companies are
concerned. These companies spend a significant amount in
advancing their pipelines.
Galectin Therapeutics Inc.
) pipeline looks promising with candidates like GR-MD-02 and
GM-CT-01. Galectin Therapeutics recently received U.S. Food and
Drug Administration (FDA)'s approval to proceed with its phase Ib
study on GR-MD-02 in combination with
Bristol-Myers Squibb Co.
) Yervoy. The candidate is being evaluated for the treatment of
metastatic melanoma. This study will be conducted at Providence
Portland Medical Center in Portland, Ore.
An Investigational New Drug (IND) application for GR-MD-02 for
the treatment of metastatic melanoma was filed in late Dec
The phase Ib study will evaluate escalating dosage of GR-MD-02
in conjunction with the standard therapeutic dose of Yervoy in
patients with advanced melanoma. For these patients Yervoy would
be considered as the standard of care. Enrollment is expected to
commence in March this year.
This study will monitor toxicity and clinical response. Blood
samples will also be obtained to assess immunologic measures
relevant to galectin biology and ipilimumab T-cell check-point
As per information provided by the American Cancer Society,
more than 76,000 new diagnoses and 9,100 deaths from melanoma
occurred in the U.S. in 2012.
Other than metastatic melanoma, GR-MD-02 is also studied in
phase I for the treatment of nonalcoholic steatohepatitis (NASH)
with advanced fibrosis. NASH is also known as fatty liver
disease. Galectin Therapeutics completed enrolling patients in
the first cohort of the phase I study on GR-MD-02 on Jan 13,
2014. Galectin Therapeutics might start a phase II study in late
2014 or early 2015 based on phase I study results and expects
phase II top-line data in the first half of 2016 depending on the
design of the study.
Another candidate in the company's pipeline, GM-CT-01, is
currently in phase I/II for the treatment of metastatic melanoma
skin cancer. GM-CT-01 is studied as a combination therapy with a
tumor vaccine in patients with advanced melanoma.
Galectin Therapeutics carries a Zacks Rank #3 (Hold). Some
better-ranked players in the pharma industry include
Salix Pharmaceuticals Ltd.
Lannett Company, Inc.
). Salix carries a Zacks Rank #1 (Strong Buy) while Lannett Co.
carries a Zacks Rank #2 (Buy).
BRISTOL-MYERS (BMY): Free Stock Analysis
LANNETT INC (LCI): Free Stock Analysis Report
SALIX PHARM-LTD (SLXP): Free Stock Analysis
To read this article on Zacks.com click here.