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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: November 19, 1998
Commission File Number: 0-18976
CELTRIX PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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<S> <C>
DELAWARE 94-3121462
(State or other jurisdiction (I.R.S. Employer Identification No.)
of incorporation or organization)
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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 November 19, 1998, Celtrix Pharmaceuticals, Inc., a Delaware corporation
(the "Company") announced Celtrix's SomatoKine(R) Improves Cardiac Function In
Victims of Burn Trauma. Further details regarding this announcement are
contained in the Company's news release dated November 19, 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 November 19,
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: November 19, 1998 By: /s/ DONALD D. HUFFMAN
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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
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Exhibit 21 Celtrix Pharmaceuticals, Inc. Press Release
dated November 19, 1998.
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EXHIBIT 21
NEWS RELEASE
CONTACT: Andreas Sommer, Ph.D.
President and Chief Executive Officer
(408) 450-5503
CELTRIX'S SOMATOKINE(R) IMPROVES CARDIAC FUNCTION
IN VICTIMS OF BURN TRAUMA
RESULTS HAVE POTENTIAL WIDESPREAD APPLICATION FOR HEART PATIENTS
SANTA CLARA, CA -- November 19, 1998 -- Celtrix Pharmaceuticals, Inc.
(Nasdaq: CTRX) announced that data presented at the American Heart Association
Conference in Dallas, TX, show statistically significant effects of
SomatoKine(R) treatment on cardiac function in burn trauma patients.
Following severe burn injury, heart and circulatory functional changes
occur including relative depression of heart function. This in turn may lead to
inadequate blood supply to other parts of the body. Inadequate blood supply can
result in tissue damage, organ failure, shock and ultimately death.
J. Rai, M.D. and her colleagues at the Shriners Hospital for
Children-University of Texas Medical Branch in Galveston showed that six
severely burned children receiving an intravenous infusion of SomatoKine,
Celtrix's novel IGF-BP3 compound, for five days, showed a 16% improvement in
cardiac output and a 15% increase in stroke volume over saline-treated controls.
Other patients treated with different dose levels showed a lesser response. No
side effects were noted and the observed improvements were not accompanied by
undesirable increases in left ventricular wall thickness or increased oxygen
consumption by the heart muscle.
"Although anabolic agents such as insulin-like growth factor-I (IGF-I) have
been known to attenuate cardiac dysfunction after severe burn trauma, the use of
these agents in burn therapy has been complicated by systemic side effects such
as hypoglycemia," commented Dr. Jyoti Rai, principal investigator. "On the other
hand, SomatoKine (IGF-I complexed to its major binding protein, BP-3) has
demonstrated efficacy and an impressive safety profile."
"This degree of improvement in heart function is sufficient to potentially
improve overall outcomes in patients with cardiac dysfunction in association
with large burns. In addition, this may also be beneficial to patients with
acute or chronic cardiac dysfunction in a variety of disease states, including
other forms of trauma and chronic congestive heart failure," stated Martin E.
Sanders, M.D., medical consultant to Celtrix for this study.
Andreas Sommer, Ph.D., Celtrix's president and chief executive officer,
added, "These data are the latest findings from our Phase II clinical trials
involving patients with severe burns. They are further indication of
SomatoKine's multi-functional activity in counterbalancing adverse conditions
induced by trauma. We have reported previously on the drug's ability to reverse
the catabolic condition which leads to degradation of muscle tissue and its
positive effect on the immune system."
-more-
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"Celtrix's SomatoKine Improves Cardiac Function in Victims of Burn Trauma"
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CELTRIX PHARMACEUTICALS
Celtrix is a biopharmaceutical company developing therapeutics for
seriously debilitating, degenerative conditions primarily associated with severe
trauma, chronic diseases or aging. The company's focus is on SomatoKine, the
novel IGF-BP3 complex, for treatment of a broad range of metabolic disorders.
SomatoKine is currently undergoing Phase II clinical testing for the treatment
of severe osteoporosis (recovery from hip fracture surgery), traumatic burns and
diabetes. Celtrix has also licensed rights for development of another molecule,
TGF-beta-2, to Genzyme Corporation for incorporation into their comprehensive
program for tissue repair. TGF-beta-2 is currently in Phase II clinical testing
for treatment of dermal ulcers.
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 outcomes of future clinical trials
involving SomatoKine and the ability to enter into collaboration(s) with
corporate partners, as well as risks associated with future research, 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-
