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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report: May 4, 1998
Commission File Number: 0-18976
CELTRIX PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
DELAWARE 94-3121462
(State or other jurisdiction (I.R.S. Employer Identification No.)
of incorporation or organization)
3055 Patrick Henry Drive, Santa Clara, CA 95054-1815
(Address of principal executive offices and zip code)
Registrant's Telephone Number: (408) 988-2500
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ITEM 5. OTHER EVENTS
On May 4, 1998, Celtrix Pharmaceuticals, Inc., a Delaware corporation
(the "Company") announced Initial Clincial Results Reported on Celtrix's
SomatoKine(R) Treatment for Severe Burns. Further details regarding this
announcement are contained in the Company's news release dated May 4, 1998,
attached as exhibit hereto and incorporated by reference herein.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
(A) EXHIBITS
Exhibit 21 Celtrix Pharmaceuticals, Inc. News Release dated May 4, 1998.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
CELTRIX PHARMACEUTICALS, INC. (Registrant)
Date: May 4, 1998 By: /s/ DONALD D. HUFFMAN
-------------------------
Donald D. Huffman
Vice President, Finance & Administration Chief
Financial Officer (Duly authorized principal
financial and accounting officer.)
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CELTRIX PHARMACEUTICALS, INC.
INDEX TO EXHIBITS
Exhibit Number
Exhibit 21 Celtrix Pharmaceuticals, Inc. Press Release
dated May 4, 1998.
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CELTRIX LETTERHEAD
NEWS RELEASE
CONTACT: Andreas Sommer, Ph.D.
President and Chief Executive Officer
(408) 988-2500
INITIAL CLINICAL RESULTS REPORTED ON
CELTRIX'S SOMATOKINE(R) TREATMENT FOR SEVERE BURNS
PHASE II CLINICAL FEASIBILITY STUDY DEMONSTRATING
POSITIVE IMMUNE RESPONSE IN SEVERELY BURNED CHILDREN
NEW YORK, NY -- May 4, 1998 -- In Phase II clinical feasibility studies
for the treatment of severe burns, systemic administration of SomatoKine(R)
therapy is demonstrating a positive effect on the immune system of severely
burned children. SomatoKine is a novel IGF-BP3 therapeutic agent developed by
Celtrix Pharmaceuticals, Inc. (Nasdaq: CTRX).
Initial data on SomatoKine-treated burn patients presented at The
Surgical Infection Society conference in New York by clinical researchers from
Shriners Hospital for Children, Galveston, and the University of Texas Medical
Branch, Galveston, Texas, show positive effect on the immune system. According
to the data, lymphocytes isolated from treated patients showed a 280% increase
in the production of interleukin-2, a key immune system modulator, and a 25-90%
increase in the production of interferon gamma, another key immune system
modulator. Importantly, the immunomodulatory effect of SomatoKine treatment may
persist beyond the treatment period.
"These early findings, which involve a small group of patients, indicate
potentially important trends with SomatoKine," said Andreas Sommer, Ph.D.,
President and Chief Executive Officer at Celtrix. "Severe burns can cause
significant imbalances in the immune system. However, SomatoKine treatment
appears to be normalizing immune functions that protect patients from
infections. Such protection may be vital, since infections can interfere with
skin graft procedures and, in serious cases, trigger multi-system organ failure
and death."
"Several other parameters, in particular the healing time of donor
tissue sites, are also under investigation," Dr. Sommer said. "Various findings
from ongoing studies are expected to be reported in scientific forums during
1998 and will serve as the basis for initiating full-scale Phase II/III clinical
studies in 1999. Our ultimate objectives are to speed patients' recovery time
and reduce their hospital stay."
CLINICAL STUDY OVERVIEW
Celtrix's Phase II clinical feasibility studies for the treatment of
severe burns are being conducted at multiple medical centers throughout the
United States. The study reported today was conducted by clinical investigators
affiliated with the Shriners Hospital for Children, Galveston, and the
Department of Surgery and Department of Internal Medicine, Division of
Infectious Diseases, University of Texas Medical Branch, Galveston, Texas.
Reported data are based on the treatment of six severely burned
children, ages two to eighteen. The patients received SomatoKine by continuous
intravenous infusion for up to 7 days during acute hospitalization. Therapy was
discontinued when donor tissue sites were 95% healed. Patients served as their
own control, for comparison of immune responses without SomatoKine treatment
versus with SomatoKine treatment.
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"Initial Clinical Results Reported on Celtrix's SomatoKine(R) Treatment For
Severe Burns"
Page 2
"We were particularly interested in lymphocyte (T-helper cell)
production of key immune system proteins called cytokines ," said David N.
Herndon, M.D., lead investigator. Dr. Herndon is Chief of Staff, Shriners
Hospital for Children, Galveston, and Professor of Surgery, Jesse H. Jones
Distinguished Chair of Burn Surgery, University of Texas Medical Branch.
"Major burn injury is associated with a shift in the production of
cytokines," Dr. Herndon said. "Most notably, levels of interleukin-2 and
interferon gamma decrease substantially, while levels of interleukin-4 and
interleukin-10 rise. The resulting imbalance causes inappropriate immune
responses that can increase patients' susceptibility to serious infections."
"In the SomatoKine study, each patient's immune status was assessed by
obtaining blood samples and measuring the production of various cytokines. Our
conclusion," Dr. Herndon said, "is that the administration of SomatoKine had a
significant beneficial effect on restoring balance to the immune system. While
more research is needed, we are encouraged that this treatment may improve T
cell-mediated immune responses important to the healing process in burn
patients."
Annually, approximately 25,000 people worldwide (10,000 people in the
United States) suffer from severe burns.
THE SOMATOKINE COMPLEX
SomatoKine is the recombinant equivalent of the natural complex formed
by insulin-like growth factor-I, which is an anabolic hormone, and its major
binding protein ("IGF-BP3 complex"). Following traumatic injury, blood levels of
IGF-BP3 drop substantially. With the trauma of severe burns, this drop appears
to be associated with imbalances in various biological processes that may impact
the length of time patients spend in a burn trauma center. Treatment with
SomatoKine offers the potential to restore biological processes that would allow
more frequent donor site harvesting, decrease the risk of complications,
accelerate wound healing, and shorten the patient's hospital stay.
ADDITIONAL INFORMATION
Celtrix is a biopharmaceutical company developing novel therapeutics for
seriously debilitating, degenerative conditions primarily associated with severe
trauma, chronic diseases or aging. The company's development focus is on
SomatoKine, a novel IGF-BP3 complex, for use in regenerating lost muscle, bone
and other tissues essential for the patient's health and quality of life.
Ongoing product development programs target acute traumatic injury, such as hip
fracture surgery in the elderly and severe burns. SomatoKine is currently
undergoing Phase II clinical feasibility testing for these two indications.
Other potential indications include severe osteoporosis and protein wasting
diseases associated with cancer, AIDS and other life-threatening conditions.
Through strategic alliances with Celtrix, Yoshitomi Pharmaceutical Industries
Ltd. is developing SomatoKine for the treatment of osteoporosis in Japan, and
Genzyme Corporation is developing TGF-beta-2 as part of a comprehensive approach
to tissue repair and the treatment of systemic disease.
This news release contains certain forward-looking statements within the
meaning of Section 21E of the Securities Exchange Act of 1934, as amended.
Actual results may differ materially from the statements made, as a result of
various factors, including risks associated with the continuation of the same
observations in future clinical trials involving SomatoKine for the treatment of
severe burns, as well as risks associated with future research, clinical study
results, the regulatory approval process, competitive products and other factors
which are listed from time to time in Celtrix's Securities and Exchange
Commission (SEC) filings. These forward-looking statements represent Celtrix's
judgment as of the date of this news release.
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