
Genaera Announces Advanced
Ovarian Cancer Clinical Trial Results for Squalamine at American Society
of Clinical Oncology Meeting
Plymouth
Meeting, PA, May 20, 2002 - Genaera Corporation (NASDAQ: GENR)
announced today the presentation of encouraging results for its anti-angiogenic
drug, squalamine, in its phase 2 recurrent advanced ovarian cancer
clinical trial, at the meeting of the American Society of Clinical
Oncology (ASCO) in Orlando, Florida.
The ongoing phase
2 clinical trial in recurrent advanced ovarian cancer is a multi-center,
open label design, evaluating squalamine in combination with carboplatin.
In this study, 35% of evaluable patients (9 of 26) have had an objective
response to the study drug regimen of squalamine and carboplatin.
Best response to therapy has included five complete responses, and
four partial responses. Four of the responses were in patients enrolled
with measureable disease, and five have been in patients enrolled
with rising and elevated levels of Ca-125 tumor marker, consistent
with early ovarian cancer recurrence. For this study, squalamine is
dosed at 200 mg/m2/day, daily for five days, immediately following
carboplatin infusion, every 3 weeks.
Susan Davidson,
MD, Chief, Gynecologic Oncology at the University of Colorado Health
Sciences Center, commented, "Patients with recurrent ovarian
cancer desperately need alternatives to currently available treatments.
Squalamine is a novel anti-angiogenic drug with a unique mechanism
of action, and the results to date in ovarian cancer, both pre-clinically
and in this initial clinical trial, are encouraging. Based on these
results, obtained in treating a mixed population of patients with
recurrent advanced ovarian cancer with squalamine and carboplatin
therapy, I feel that further evaluation of this treatment strategy
is certainly indicated."
Roy C. Levitt,
MD, President and Chief Executive Officer of Genaera, commented, "These
clinical results with squalamine in ovarian cancer provide evidence
of its tremendous potential as a unique anti-angiogenic therapy for
cancer. Based on our understanding of squalamine's unique mechanism
of action, and our impressive preclinical results from the laboratories
of multiple well-known clinicians and scientists in oncology and ophthalmology,
we anticipate these beneficial results will continue, for both cancer
and macular degeneration. In recurrent ovarian cancer, we look forward
to commencing our registration trial."
Enrollment for
the phase 2 ovarian cancer clinical trial is complete at 42 patients,
of which 31 patients have completed at least two cycles of therapy
and are thereby considered evaluable for efficacy. Results are not
complete for five patients enrolled in the study, who have all completed
at least two cycles of therapy. Patients in the study are currently
being followed to determine time to progression and survival.
Squalamine has
been granted Orphan Drug designation for the treatment of ovarian
cancer by the U.S. Food and Drug Administration (FDA). A registration
trial in recurrent ovarian cancer is currently planned to begin in
2002.
The Company has
performed clinical trials evaluating squalamine in the treatment of
non-small cell lung cancer, ovarian cancer, and other adult solid
tumors. Genaera also anticipates the start of clinical trials in age-related
macular degeneration (AMD) in 2002. Squalamine is the first clinical
drug candidate in a class of naturally occurring, pharmacologically
active, small molecules known as aminosterols. Squalamine is a potent
anti-angiogenic molecule with a unique multi-faceted mechanism of
action that blocks the action of a number of angiogenic growth factors,
including vascular endothelial growth factor (VEGF).
Genaera Corporation
is a biopharmaceutical company committed to developing medicines for
serious diseases from genomics and natural products. Research and
development efforts are focused on antiangiogenesis, obesity, infectious
diseases and respiratory diseases. Genaera has four products in development
addressing substantial unmet medical needs in major pharmaceutical
markets. These include squalamine, an anti-angiogenesis treatment
for cancer and eye disease; trodulamine, an appetite suppressant for
medically significant obesity; interleukin-9 antibody, a respiratory
treatment based on the discovery of a genetic cause of asthma; and
LOMUCIN, a mucoregulator to treat the overproduction of mucus
and secretions involved in many forms of chronic lung disease.
This announcement
contains forward-looking statements that are subject to risks and
uncertainties. Forward-looking statements reflect management's current
views and are based on certain expectations and assumptions. Such
statements include, among others, statements regarding the preliminary
results and future clinical development plans and prospects for squalamine
(for lung cancer, ovarian cancer and in other indications), the IL-9
antibody program, the small molecule mucoregulator program, and trodulamine.
You may identify some of these forward looking-statements by the use
of words in the statements such as "look forward," "planned,
"anticipate," "develop," "continuing,"
and "progress," or other words of similar meaning. Genaera's
actual results and performance could differ materially from those
currently anticipated and expressed in these and other forward-looking
statements as a result of a number of factors, including, but not
limited to, the additional data to be collected from the clinical
trials, results of additional clinical development plans, results
of ongoing preclinical and clinical studies in our drug development
candidates, general financial, economic, regulatory and political
conditions affecting the biotechnology industry and the other risks
and uncertainties discussed in this announcement and in Genaera's
filings with the U.S. Securities and Exchange Commission. Genaera
does not intend (and it is not obligated) to publicly update, revise
or correct these forward-looking statements. This discussion is permitted
by the Private Securities Litigation Reform Act of 1995.
