I thought I uploaded this last night, but now can't find it on the thread:
Seragen Announces Investigational Results of Pivotal
Cutaneous T-Cell Lymphoma Trial
Lymphoma Trial
HOPKINTON, Mass., Dec. 9 /PRNewswire/ -- Seragen, Inc.
(OTC Bulletin Board: SRGN) announced investigational results today of a
pivotal clinical trial of DAB389IL-2 (Interleukin-2 Fusion Protein or
denileukin diftitox) for possible use in cutaneous T-cell lymphoma (CTCL).
One of the investigators in the trial, Timothy Kuzel, M.D., Associate
Professor of Medicine in the Division of Hematology/Oncology at Northwestern
University Medical School, presented the preliminary results at the annual
meeting of the American Society of Hematology in San Diego. Dr. Kuzel
characterized DAB389IL-2 as potentially having clinically significant anti-
tumor effects, even in patients with advanced CTCL who have received multiple
prior therapies.
The randomized trial of DAB389IL-2 provides the primary data in support of
a biologics license application (BLA) submitted last week by Seragen to the
U.S. Food and Drug Administration (FDA) requesting clearance to market
DAB389IL-2 for the treatment of recurrent or persistent CTCL despite prior
therapy.
The trial was designed to assess the safety and efficacy of treatment with
DAB389IL-2 at two dose levels in the target patient population. Investigators
evaluated reduction in tumor burden, change in various measures of
symptomatology, and a number of dimensions of quality of life. Seventy-one
patients with CTCL who had failed an average of five prior therapies are
included in the analysis. All response data were reviewed and verified by an
independent data review committee. The FDA will now have to review and verify
the data before DAB389IL-2 is cleared for marketing.
Seragen's preliminary analysis of the data indicates that, overall, 30
percent of the patients treated with DAB389IL-2 demonstrated a protocol-
defined response of 50 percent or greater reduction in tumor burden lasting at
least six weeks--a response consistent with results of an earlier Phase I/II
study. Preliminary statistical analysis of the trial results indicate that
the true response rate, based on a 95 percent confidence interval, lies
between 18 and 41 percent. Patients in the higher dose group had a greater
response than patients in the lower dose group; the difference in response
rate between dose groups was not statistically significant. Approximately ten
percent of all patients showed complete resolution of all evidence of tumor.
Dr. Kuzel pointed out that symptoms improved in all patients classified as
responders and in 80 percent of patients who did not qualify as responders.
He also said that statistically significant differences were noted in four
measures of quality of life for responders compared to non-responders.
Preliminary analysis revealed that multiple adverse events occurred in
both treatment groups. Clinical syndromes included hypersensitivity/infusion-
related effects, constitutional (flu-like) symptoms, and the development of a
vascular leak disorder. Acute treatment effects responded to slowing the rate
of drug infusion and administration of anti-histamines. Rashes were also
reported.
Thirty-seven percent of the patients withdrew from the trial because of
adverse events. Some of the adverse events that led to discontinuation of
therapy included infectious complications, cardiovascular changes (unstable
angina, arrhythmia) and neurological changes (confusion, amnesia). Dr. Kuzel
pointed out that, in general, the study enrolled older patients who had
advanced-stage disease and who had received multiple prior therapies. He also
said that patients with CTCL are particularly susceptible to infections
because of the compromised condition of their skin.
"We are gratified by these results," said Seragen president and chief
technology officer Jean Nichols, Ph.D. "and we look forward to working with
the FDA as this compound progresses through the regulatory review process."
CTCL is a form of non-Hodgkin's lymphoma that manifests initially in the
skin. With time, however, the disease can become systemic, involving the
lymph nodes and the spleen, liver and other organs. CTCL is disfiguring and
debilitating; median survival for late-stage patients with organ or lymph node
involvement is less than three years. In general, treating physicians find
that spontaneous remission does not occur once the disease has progressed
beyond Stage Ia. Various drugs are used in treating the disease, but no drug
is specifically indicated by the FDA for its treatment.
Seragen is a biopharmaceutical company developing a proprietary portfolio
of therapeutic products. The company's unique receptor-active fusion proteins
consist of a toxin fragment genetically fused to a hormone, or growth factor,
that targets specific receptors on the surface of disease-causing cells.
Seragen's current focus is on cancer and dermatology. In addition to the
collaboration with Eli Lilly and Company on the development of DAB389IL-2
(denileukin diftitox) for CTCL, Seragen is independently conducting clinical
trials of the same molecule for psoriasis. A second product, EGF Fusion
Protein, is currently in a Phase I/II clinical trial for non-small cell lung
cancer and in pre-clinical development in collaboration with United States
Surgical Corporation for restenosis following angioplasty.
Safe Harbor Information
Some of the statements contained in this document are forward-looking,
including statements relating directly or by implication to Seragen's
products, operations, strategic partnerships, financial condition, and ability
to fund its operations. These statements are based on current expectations
and involve a number of uncertainties and risks, including (but not limited
to) Seragen's ability to proceed with successful development, testing, and
licensing of its products, to modify certain existing contractual
arrangements, to enter into additional strategic partnerships and other
collaborative arrangements, and to raise additional capital on satisfactory
terms. For further information, refer to the "Business Outlook" section in
Seragen's Form 10-K as filed with the Securities and Exchange Commission.
Actual results may differ materially from such expectations.
SOURCE Seragen, Inc.
-0- 12/9/97
/CONTACT: Lora Maurer of Seragen, Inc., 508-435-2331/
(SRGN)
CO: Seragen, Inc.
ST: Massachusetts
IN: MTC
SU: PDT
LZ
-- NETU035 --
4658 12/09/97 17:10 EST prnewswire.com |
