Here's the psoriasis data:
Patients Using Seragen's Psoriasis Drug; Company Initiates Additional Trial
WASHINGTON, Nov. 13 /PRNewswire/ -- Speaking at an International Business
Communications conference on psoriasis in Washington, D.C. today,
dermatologist Jerry Bagel, M.D., disclosed that patients receiving a four-week
course of Seragen, Inc.'s (Nasdaq: SRGN) DAB389IL-2 receptor-active protein in
a Phase II clinical trial showed statistically significant improvement
compared to patients who received a placebo. Overall, 12 of 27 patients (44
percent) who received at least one dose of DAB389IL-2 exhibited at least 50
percent improvement from mean baseline disease severity scores. Only three of
12 patients (25 percent) treated with placebo showed similar improvement.
Dr. Bagel further noted that, in general, patients who received DAB389IL-2
and had improved psoriasis severity scores also had improved "quality of life"
scores and reduction of lesion thickness. On the other hand, placebo patients
did not show significant improvement in these measures of benefit.
"Patient improvement, as measured by change in the standard psoriasis
severity index, was comparable in two separate studies of the drug," Dr.
Bagel, director of the Psoriasis Treatment Center of Central New Jersey in
East Windsor, stated.
Dr. Bagel presented a summary of the findings from two studies involving
patients with moderate-to-severe psoriasis: Seragen's original open-label
Phase I/II psoriasis study consisting of five consecutive treatment days per
month; and a double-blind placebo-controlled Phase II study consisting of
three treatment days per week for four weeks.
The Phase II study tested doses of 5, 10 and 15 micrograms per kilogram
per day. Comparable improvement was observed at all three dose levels;
however, adverse events were more notable at the higher doses. Consequently,
Seragen has now initiated a dose escalation study to evaluate the potential
for anti-psoriatic effects starting at lower doses of DAB389IL-2. The new
study is being conducted at four medical centers in the U.S. Up to 45
patients will be enrolled and allocated to one of three dose groups.
"We are refining the dosing regimen for DAB389IL-2 in psoriasis," said
Seragen's president, Jean Nichols, Ph.D. "Our evidence indicates the drug is
active against psoriasis. We are now evaluating even lower doses as well as a
new schedule designed to improve the tolerability of the drug. While the
trial is taking place, we will design further psoriasis trials, some of which
may run concurrently with this trial."
Reed Prior, newly named Seragen CEO, added: "Psoriasis is a major
potential market. A recent survey reported by the National Psoriasis
Foundation estimated that 2.6 percent of the U.S. population suffers from
psoriasis. That translates into 6.4 million people. Twenty-four percent of
the patients surveyed said they had moderate psoriasis, and 9 percent, or over
half a million people, said they had severe psoriasis."
Seragen's current focus is on cancer and dermatology. In addition to the
psoriasis trial which the company is conducting independently, Seragen is
conducting PhaseIII clinical trials of DAB389IL-2 for cutaneous T-cell
lymphoma in collaboration with Eli Lilly and Company. The second product in
the company's pipeline, DAB389EGF, is currently in a clinical trial for non-
small cell lung cancer.
Seragen is an integrated biopharmaceutical company developing a
proprietary portfolio of therapeutic products. The company's unique receptor-
active 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.
Safe Harbor Information
To the extent that any of the statements contained herein relating to the
Company's products and its operations are forward looking, such statements are
based on current expectations that involve a number of uncertainties and
risks. Such uncertainties and risks include, but are not limited to, the
early stage of the Company's product development and lack of product revenues;
the Company's history of operating losses and accumulated deficit; the
Company's limited financial resources and uncertainty as to the availability
of additional capital to fund its development on acceptable terms, if at all;
Boston University's control of the Company; the Company's reliance on fusion
protein technology; the potential development of competing fusion proteins,
products and technologies; the Company's dependence on its collaborative
partner, Eli Lilly and Company, and the lack of assurance that the Company
will receive further funding under this partnership or develop and maintain
other strategic alliances; the lack of assurance regarding patent and other
protection for the Company's proprietary technology; governmental regulation
of the Company's activities, facilities and products; the Company's limited
manufacturing capabilities; the Company's lack of commercial sales and
marketing capabilities; the dependence on key personnel; the development of
competing technologies; uncertainties as to the extent of reimbursement for
the costs of the Company's potential products and related treatment by
government and private health insurers and other organizations; the potential
adverse impact of government-directed health care reform; the risk of product
liability claims; and general economic conditions. As a result, the Company's
future development efforts involve a high degree of risk. For further
information, refer to the risk factors included in the Company's Registration
Statement on Form S-3, Registration No. 333-12613, relating to the resale of
shares of Common Stock, as filed with the Securities and Exchange Commission.
Actual results may differ materially from such expectations.
SOURCE Seragen, Inc.
-0- 11/13/96
/CONTACT: Lora Maurer, Manager, IR/Corporate Communications of
Seragen, Inc., 508-435-2331 or Seragen@aol.com or Media: Joe Dodson or Bob
Stone or IR: Ken Di Paola or Bob Stone, of The Dilenschneider Group,
212-922-0900/
(SRGN)
CO: Seragen, Inc.
ST: Massachusetts, District of Columbia
IN: MTC
SU: PDT
LZ
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4345 11/13/96 15:37 EST prnewswire.com |
