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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: June 15, 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 June 15, 1998, Celtrix Pharmaceuticals, Inc., a Delaware corporation
(the "Company") announced SomatoKine(R) Demonstrates Potential to Treat Protein
Wasting Diseases. Further details regarding this announcement are contained in
the Company's news release dated June 15, 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 June 15, 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: June 15, 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
<TABLE>
<CAPTION>
Exhibit Number
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<S> <C>
Exhibit 21 Celtrix Pharmaceuticals, Inc. Press Release
dated June 15, 1998.
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Exhibit 21
[CELTRIX LETTERHEAD]
NEWS RELEASE
CONTACT: David M. Rosen, Ph.D.
Senior Vice President,
Research and Development
(408) 988-2500
CELTRIX'S SOMATOKINE(R) DEMONSTRATES POTENTIAL
TO TREAT PROTEIN WASTING DISEASES
PRELIMINARY RESULTS OF PHASE II SEVERE BURNS TRIAL
SANTA CLARA, CA -- June 15, 1998 -- Celtrix Pharmaceuticals, Inc.
(Nasdaq: CTRX) today announced that preliminary data from an ongoing Phase II
feasibility study in burn patients provide evidence supporting the use of
SomatoKine(R), the company's novel IGF-BP3 complex, to treat the degradation of
muscle tissue ("protein wasting") that is associated with severe trauma
including burn injury, or chronic illness including cancer, AIDS, and advanced
kidney failure.
"The data obtained from the treatment of six severely burned adults with
SomatoKine suggest substantial improvement in restoring the balance between
protein synthesis and degradation, a prerequisite for accelerated wound healing
and reduced hospital stay," said Andreas Sommer, Ph.D., Celtrix's president and
chief executive officer. "These are the first human data to demonstrate the
efficacy of SomatoKine in the treatment of serious medical conditions associated
with muscle and weight loss."
In burn patients, the balance between protein synthesis and degradation
is shifted towards degradation, leading to muscle and weight loss which in turn
leads to delayed wound healing and increases in infectious complications and
mortality.
Investigator David N. Herndon, M.D. and his colleagues at the University
of Texas Medical Branch in Galveston assessed the effect of intravenous
administration of SomatoKine at two dose levels (2 and 4 mg/kg) on attenuating
protein degradation in six severely burned adults. The investigators employed an
amino acid tracer exchange technique across muscle tissue, which allowed the
assessment of skeletal muscle protein synthesis and degradation. "SomatoKine
treatment resulted in a 58% improvement, compared to control, at the 2 mg/kg
dose, and 34% at the 4 mg/kg dose," commented Dr. Herndon. "Based on these
results, we are encouraged that SomatoKine may be effective in attenuating the
protein wasting response to burns, and holds promise to prevent the severe
weight loss that occurs in these patients."
This Phase II feasibility study, which is evaluating a variety of
parameters important to the treatment of severe burns, is continuing in
additional patients and at other dosage levels. Celtrix expects to complete its
final patient follow-up and data analysis in the fourth quarter of 1998. The
results will guide the design of a pivotal Phase III trial in burn patients
expected to begin in 1999.
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"Celtrix's SomatoKine(R) Demonstrates Potential to Treat Protein Wasting
Diseases" Page 2
"The diseases associated with protein wasting, such as cancer cachexia,
AIDS wasting, severe trauma, and advanced kidney failure, offer major
opportunities for future SomatoKine development," commented Dr. Sommer. "Celtrix
is actively seeking corporate collaborations for further clinical evaluation and
development in these areas."
THE SOMATOKINE COMPLEX
SomatoKine is the recombinant equivalent of the natural complex formed
by the anabolic hormone insulin-like growth factor-I (IGF-I) and its major
binding protein (BP3). IGF-I is an important anabolic hormone responsible for a
broad range of metabolic processes in the body. When people age, suffer chronic
disease or experience serious trauma, levels of IGF-I in their blood are
substantially reduced, resulting in a broad range of deleterious effects (e.g.,
destructive metabolic processes, compromised immune systems, poor nutritional
efficiency) that slow healing and impede recovery. Celtrix is clinically
evaluating the ability of SomatoKine to overcome these problems and thereby
improve patients' health, increase their quality of life and reduce their
hospital costs.
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 alliance with Celtrix, 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 21 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 and other diseases associated with protein wasting, 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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