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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: July 1, 1997
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 July 1, 1997, Celtrix Pharmaceuticals, Inc., a Delaware corporation
(the "Company") announced it has initiated a Phase II clinical feasibility study
for the systemic treatment of severe burns. Further details regarding this
announcement are contained in the Company's news release dated July 1, 1997,
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 July 1, 1997.
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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: July 1, 1997 By: /s/ MARY ANNE RIBI
----------------------
Mary Anne Ribi
Vice President, Finance & Administration
and 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 July 1, 1997.
</TABLE>
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[CELTRIX LETTERHEAD]
NEWS RELEASE
CONTACT: David M. Rosen, Ph.D.
Vice President, Research and Development
(408) 988-2500
CELTRIX INITIATES PHASE II CLINICAL FEASIBILITY STUDY
FOR THE SYSTEMIC TREATMENT OF SEVERE BURNS
FOCUSED ON SPEEDING PATIENT RECOVERY AND REDUCING HOSPITAL STAY
SANTA CLARA, CA -- July 1, 1997 -- Celtrix Pharmaceuticals, Inc.
(Nasdaq: CTRX) announced today that it has initiated a Phase II clinical
feasibility study for the systemic treatment of severe burns using
SomatoKine(R), its novel IGF-BP3 complex. This is Celtrix's second Phase II
feasibility study with SomatoKine. In January 1997, the company initiated
clinical feasibility testing for recovery from hip fracture surgery.
"Our primary objectives in the burn study are to speed the patients'
recovery time and reduce their hospital stay," said Andreas Sommer, Ph.D.,
Celtrix's president and chief executive officer. "The length of time spent in a
burn trauma center is directly related to the time required for sufficient
healthy tissue to be harvested and then grafted at burn sites. With the trauma
of severe burns, key metabolic processes are impaired, and the patient's body is
unable to properly utilize nutrients essential for tissue repair and
regeneration. As a result, graft harvesting is limited, and healing is slow. An
associated loss of muscle mass further reduces the patient's strength and
mobility."
"Research suggests that low blood levels of a vital anabolic hormone,
IGF-I, may contribute significantly to these problems and that supplementation
may restore healthy metabolic processes required for healing," Dr. Sommer said.
"SomatoKine is the recombinant equivalent of the naturally occurring complex
formed in the bloodstream by IGF-I and its major binding protein, BP3. We
believe it offers significant therapeutic potential for the approximately 8,000
people annually who suffer from severe burns in the United States."
Celtrix's Phase II clinical feasibility study for burns is being
conducted in the United States and is expected to involve up to 40 severely
burned patients, including both adults and children. The patients will be
randomized to receive either SomatoKine therapy or a placebo during standard
burn care, and they will be evaluated through two graft cycles. The primary
clinical target is faster healing of the donor site which could shorten the
length of hospitalization. The study is expected to be completed during the
first half of 1998. Clinical findings should help guide the design of future
burn studies.
Celtrix is a biopharmaceutical company developing novel therapeutics
for the treatment of seriously debilitating, degenerative conditions primarily
associated with severe trauma, chronic diseases or aging. The company's focus is
on SomatoKine, a novel IGF-BP3 complex, for use in regenerating lost muscle,
bone and other tissues essential for the patient's
-more-
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"Celtrix Initiates Phase II Clinical Feasibility Study For The Systemic
Treatment of Severe Burns"
Page 2
health and quality of life. Initial product development programs target acute
traumatic injury, such as hip fracture surgery in the elderly and severe burns.
Other potential indications include severe osteoporosis and protein wasting
diseases associated with cancer, AIDS and other life-threatening conditions.
Through strategic alliances with Celtrix, The Green Cross Corporation 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 ability to enroll a
sufficient number of patients in this feasibility study as well as future
company 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.
-end-
