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company overview
is a biotechnology company committed to discovering, developing,
and commercializing novel, targeted therapies that promise to
improve outcomes for gliomas, metastatic brain tumors, and other
aggressive cancers with limited treatment options.
Our mission: To extend survival and preserve
quality of life for millions of cancer patients by providing therapies
and delivery technologies that exclusively target malignant cells
while avoiding interaction with normal, healthy cells.
– Founded in July 1996, TransMolecular is a privately held
company backed by venture capital. Since its inception, the company
has raised $42.8 million through three private placements from
internationally recognized investment firms.
The Company has built a strong management team with
extensive experience in healthcare, pharmaceutical and biotechnology
development, R&D, operations, business development, regulatory
affairs, and finance. TransMolecular's corporate offices and R&D
laboratories are in Cambridge, MA.
The Company holds more than 35 patents and/or patent
applications to protect its products worldwide, and has exclusive
license agreements with the University of Alabama at Birmingham
Research Foundation for its technology.
– Transmolecular has
developed a multi-tiered clinical research trial program to explore
the potential of radio-labeled and unlabeled TM-601 in the treatment
of high-grade glioma – a deadly form of brain cancer –
and other aggressive cancers with limited treatment options
Following the completion in 2004 of a phase
I/II clinical trial to evaluate the safety of  I-TM-601
administered through an intercavitary device to patients with
glioblastoma, the company initiated a phase II trial under orphan,
fast tract designation, to establish the efficacy, safety and
tolerability of intercavitarily-administered, radio-labeled TM-601
for the same indication. With the dose-escalating stage of this
study completed, the second, currently ongoing stage of the study
is evaluating its effects on tumor progression and survival in
54 patients with high-grade glioma. Upon completion of the phase
II study, Transmolecular plans to conduct a phase III trial to
gain FDA approval to market I-TM-601
for treatment of recurrent, high-grade glioma in the United States.
Transmolecular is also conducting imaging
studies of IV-administered I-TM-601
in patients with glioma and a variety of malignant/metastatic
tumor types. The primary objective of these studies is to determine
the efficacy of I-TM-601
in specifically localizing and interacting with tumor cells in
patients when it is administered via IV infusion.
In addition, Transmolecular recently gained FDA
approval of an IND to investigate unlabeled TM601 based on evidence
that IV-administered, unlabeled TM-601 has antitumor effects of
its own, potentially due to antiangiogenic activity. TransMolecular
is planning to conduct a clinical study to evaluate the effects
of unlabeled TM-601 alone in the treatment of high-grade glioma
that is expected to begin enrolling patients in early 2008.
As the clinical study program for TM-601 moves
forward, the company will proceed with preclinical studies and
research to determine the mechanism for the agent’s antitumor
effects and to explore its potential as a diagnostic imaging tool
for detecting primary and malignant tumors.
For more information on the clinical trial
program for TM-601, click
here.
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