Speaking of approvals:
PR NewsWire
Seragen Biologics License Application Accepted For
Filing By FDA; Application To Receive Priority Review
Application To Receive Priority Review
HOPKINTON, Mass., Feb. 4 /PRNewswire/ -- Seragen, Inc.
(OTC Bulletin Board: SRGN) announced today the U.S. Food and Drug
Administration (FDA) has informed the company that its Biologics License
Application (BLA) submitted last December has been accepted for filing. The
application requests clearance to market Seragen's DAB389IL-2 (Interleukin-2
Fusion Protein or denileukin diftitox) for the treatment of recurrent or
persistent cutaneous T-cell lymphoma (CTCL) in patients who have received
prior therapy.
In addition, the FDA has designated the application for "priority" review.
In the case of applications for drugs intended to treat certain life-
threatening illnesses, the FDA may choose to accelerate the review process.
In this case, the FDA's designation indicates the application may be reviewed
in as little as six months.
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. Various drugs are used in treating the
disease, but no drug is specifically approved by the FDA for its treatment.
Seragen's BLA is based on accumulated data from Phase I/II and Phase III
clinical trials of DAB389IL-2 in patients with CTCL who were no longer
benefiting from other therapy. Two additional trials are currently in
progress to evaluate the use of the drug in patients with CTCL who have been
less extensively pre-treated. Results of the completed Phase III trial were
presented at the annual meeting of the American Society of Hematology in
December.
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 a
collaboration with Eli Lilly and Company on the development of DAB389IL-2
(denileukin diftitox) for CTCL, Seragen is independently conducting
investigational clinical trials of the same molecule for psoriasis. A second
product, EGF Fusion Protein, is currently in a Phase I/II investigational
clinical trial for non-small cell lung cancer and is the subject of an
agreement with United States Surgical Corporation for collaborative
development 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- 02/04/98
/CONTACT: Lora Maurer of Seragen, Inc., 508-435-2331/
(SRGN)
CO: Seragen, Inc.
ST: Massachusetts
IN: MTC
SU: LIC
VV
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1878 02/04/98 11:35 EST prnewswire.com
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PR NewsWire
Seragen Biologics License Application Accepted For
Filing By FDA; Application To Receive Priority Review
Application To Receive Priority Review
HOPKINTON, Mass., Feb. 4 /PRNewswire/ -- Seragen, Inc.
(OTC Bulletin Board: SRGN) announced today the U.S. Food and Drug
Administration (FDA) has informed the company that its Biologics License
Application (BLA) submitted last December has been accepted for filing. The
application requests clearance to market Seragen's DAB389IL-2 (Interleukin-2
Fusion Protein or denileukin diftitox) for the treatment of recurrent or
persistent cutaneous T-cell lymphoma (CTCL) in patients who have received
prior therapy.
In addition, the FDA has designated the application for "priority" review.
In the case of applications for drugs intended to treat certain life-
threatening illnesses, the FDA may choose to accelerate the review process.
In this case, the FDA's designation indicates the application may be reviewed
in as little as six months.
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. Various drugs are used in treating the
disease, but no drug is specifically approved by the FDA for its treatment.
Seragen's BLA is based on accumulated data from Phase I/II and Phase III
clinical trials of DAB389IL-2 in patients with CTCL who were no longer
benefiting from other therapy. Two additional trials are currently in
progress to evaluate the use of the drug in patients with CTCL who have been
less extensively pre-treated. Results of the completed Phase III trial were
presented at the annual meeting of the American Society of Hematology in
December.
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 a
collaboration with Eli Lilly and Company on the development of DAB389IL-2
(denileukin diftitox) for CTCL, Seragen is independently conducting
investigational clinical trials of the same molecule for psoriasis. A second
product, EGF Fusion Protein, is currently in a Phase I/II investigational
clinical trial for non-small cell lung cancer and is the subject of an
agreement with United States Surgical Corporation for collaborative
development 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- 02/04/98
/CONTACT: Lora Maurer of Seragen, Inc., 508-435-2331/
(SRGN)
CO: Seragen, Inc.
ST: Massachusetts
IN: MTC
SU: LIC
VV
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1878 02/04/98 11:35 EST prnewswire.com
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