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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: December 10, 1998
Commission File Number: 0-18976
CELTRIX PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
<TABLE>
<CAPTION>
<S> <C>
Delaware 94-3121462
(State or other jurisdiction (I.R.S. Employer Identification No.)
of incorporation or organization)
</TABLE>
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 December 10, 1998, Celtrix Pharmaceuticals, Inc., a Delaware
corporation (the "Company") announced Celtrix's SomatoKine(R) Demonstrates
Significant Effects in the Treatment of Trauma-Induced Protein Wasting. Further
details regarding this announcement are contained in the Company's news release
dated December 10, 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 December 10, 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: December 10, 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 December 10, 1998.
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NEWS RELEASE
CONTACT: Andreas Sommer, Ph.D.
President and Chief Executive Officer
(408) 450-5503
CELTRIX'S SOMATOKINE(R) DEMONSTRATES SIGNIFICANT EFFECTS
IN THE TREATMENT OF TRAUMA-INDUCED PROTEIN WASTING
Results of Phase II Severe Burns Trial
SANTA CLARA, CA -- December 10, 1998 -- Celtrix Pharmaceuticals, Inc.
(Nasdaq: CTRX) announced that data presented at the Southern Surgical
Association Meeting in Palm Beach, FL, show significant beneficial effects of
SomatoKine(R) treatment on reducing protein wasting in severely burned pediatric
and adult patients.
"The data obtained from the treatment of 28 severely burned patients with
SomatoKine indicate substantial improvement in restoring the balance between
protein synthesis and degradation, a prerequisite for accelerated tissue repair
and reduced hospital stay," said Andreas Sommer, Ph.D., Celtrix's president and
chief executive officer. "These results are consistent with the findings
reported in June 1998, which were the first human data to demonstrate the effect
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 similar to
that observed in a variety of wasting conditions associated with cancer, AIDS,
and advanced kidney failure.
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 to 16 severely burned children and 12 adults with
burn sizes averaging approximately 45% of Total Body Surface Area. Using
non-radioactive amino acid tracer techniques, the investigators assessed
skeletal muscle protein synthesis (Fractional Synthesis Rate, FSR) and
degradation (Phenylalanine Net Balance, PheNB).
"We are very pleased with the results obtained with SomatoKine," commented
Dr. Herndon. "Pediatric patients showed improvements which averaged 41% for FSR
and 271% for PheNB compared to results for patients in a control group. Adults
improved an average of 79% for FSR and 70% for PheNB compared to control group
patients. Based on these results, we believe that SomatoKine may be efficacious
in attenuating the protein wasting response to burns, and holds significant
promise to prevent the severe weight loss that occurs in these patients."
Dr. Herndon added, "Although growth hormone and insulin-like growth
factor-I (IGF-I) without its binding protein have been known to improve
imbalanced metabolic conditions, the use of these agents in burn therapy has
been complicated by hyperglycemia and hypoglycemia respectively. On the other
hand, SomatoKine (IGF-I complexed to its major binding protein, BP-3) has
demonstrated efficacy and an impressive safety profile. What is particularly
exciting about these results is the fact that SomatoKine can attenuate the
adverse catabolic response to injury."
-more-
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"Celtrix's SomatoKine(R) Demonstrates Significant Effects In The Treatment Of
Trauma-Induced Protein Wasting"
Page 2
"Beyond the treatment of severely burned patients, other diseases
associated with protein wasting, such as cancer, AIDS, and advanced kidney
failure, offer major opportunities for future SomatoKine development," commented
Dr. Sommer. "Celtrix is actively seeking corporate collaborations for further
clinical evaluation of SomatoKine in burn patients and development in these
other 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 (BP-3). IGF-I is an important anabolic hormone responsible for a broad
range of metabolic processes in the body. Following traumatic injury, blood
levels of SomatoKine 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 reduce the risk of complications, accelerate tissue repair, and
shorten the patient's hospital stay.
Additional Information
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 has recently completed a Phase II feasibility trial in severely
osteoporotic patients recovering from hip fracture surgery and is currently
undergoing Phase II clinical testing for the treatment of 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 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 of the company to
enter into a collaboration with a corporate partner for the continuation of the
clinical trials in severely burned patients and the fact that the results of
this small feasibility study may or may not continue to show the same
observations, or that there may or may not be any statistically relevant results
in a larger Phase II or Phase III trial, 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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