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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 2, 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 2, 1998, Celtrix Pharmaceuticals, Inc., a Delaware corporation
(the "Company") announced Celtrix's SomatoKine(R) Demonstrates Positive Effects
In Patients Recovering From Hip Fractures Caused By Severe Osteoporosis. Further
details regarding this announcement are contained in the Company's news release
dated December 2, 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 2, 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 2, 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 2, 1998.
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EXHIBIT 21
NEWS RELEASE
CONTACT: Andreas Sommer, Ph.D.
President and Chief Executive Office
(408) 450-5503
CELTRIX'S SOMATOKINE(R) DEMONSTRATES POSITIVE EFFECTS
IN PATIENTS RECOVERING FROM HIP FRACTURES CAUSED BY
SEVERE OSTEOPOROSIS
Hip Bone Mineral Density and Tests of Functional Ability Indicate
SomatoKine's Potential as Treatment for Severe Osteoporosis
SANTA CLARA, CA -- December 2, 1998 -- Celtrix Pharmaceuticals, Inc.
(Nasdaq: CTRX) today reported final results from its Phase II clinical
feasibility study using SomatoKine(R) in the treatment of severely osteoporotic
hip fracture surgery patients. The 26 patient, double-blinded and
placebo-controlled multi-center study involved the treatment of severely
osteoporotic patients recovering from hip fracture surgery. Patients were
treated with either SomatoKine or a placebo for 2 months beginning shortly after
hip fracture surgery and their progress was followed for a total of 6 months.
The final data reveal significant treatment results in several key measurements
including hip bone mass and tests of functional ability.
The clinical data were presented by Piet Geusens, M.D., Ph.D., one of
the principal investigators, at the joint meeting of the American Society for
Bone and Mineral Research and the International Bone and Mineral Research
Society in San Francisco.
"We are very excited by the findings," said Andreas Sommer, Ph.D.,
Celtrix's president and chief executive officer. "Interim results reported in
March 1998 provided a first indication of the potential positive effects of
SomatoKine in severely osteoporotic hip fracture patients. The final data are
consistent with the previously reported findings at the 3 month midpoint of the
study. The results suggest that SomatoKine amplifies the body's natural bone
metabolism. Short-term treatment with SomatoKine appears to have sustained
effects. The findings suggest the potential usefulness of SomatoKine for the
treatment of severe osteoporosis."
Hip fracture patients are known to lose 5-9% of hip bone mineral
density during the first 3 to 6 months following surgery which places them at
high risk of re-fracture. However, after an initial loss of hip bone mineral
density following hip fracture surgery, patients treated for 8 weeks with 1.0
mg/kg per day of SomatoKine regained a substantial portion of their hip bone
mineral density. At 3 months post-surgery, they showed a hip bone mineral
density decrease of less than 2% from baseline value. Remarkably, while only
treated with SomatoKine for 2 months, these patients retained the rebuilt bone
mass to the conclusion of the study 6 months post-surgery.
Placebo patients and those treated with a lower dose of SomatoKine
failed to regain lost bone. At 6 months post-surgery, placebo-treated patients
had lost, as expected, approximately 6-7% of hip bone mineral density. Patients
treated with lower doses of SomatoKine lost hip bone mineral density similar to
the placebo-treated patients. To put this into perspective, population studies
show that a 5% decrease in hip bone mineral density increases the risk of
fracture by approximately 25%. Recovery from a second hip fracture can be
difficult and lengthy and patients often do not regain pre-fracture mobility.
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"Celtrix's SomatoKine Demonstrates Positive Effects in Patients Recovering
from Hip Fractures Caused by Severe Osteoporosis"
Page 2
Regaining strength and mobility is essential to recovery and
longer-term patient health. Two important measures of strength and independence
are grip strength and the ability to rise without assistance from the sitting
position. Patients treated with 1.0 mg/kg per day of SomatoKine improved grip
strength by approximately 10% while placebo patients recorded a reduction in
grip strength of approximately 10%. Approximately 85% of the patients treated
with 1.0 mg/kg per day were able to raise themselves from an armless chair
without assistance from equipment or human help at 3 and 6 months post-surgery.
By comparison, 3 months post-surgery, only 55% of the placebo and low dose
patients could rise without help from equipment or another person, and this
improved to only 60% by the end of the study.
"There was a good rationale to carry out this study," said Piet
Geusens, M.D., Ph.D., the study's coordinating principal investigator and
Professor of Rheumatology at the Dr. L. Willems-Instituut in Belgium. "IGF-I,
the anabolic component of SomatoKine, is one of the most abundant growth factors
in bone, and levels in blood circulation and bone are known to decline with
aging. Strong pre-clinical data suggested that SomatoKine may have positive
effects on bone and muscle function. In addition, earlier human studies with
SomatoKine revealed an impressive safety profile. I am excited about the outcome
of this trial and look forward to further development of SomatoKine for the
treatment of severe osteoporosis."
"I was particularly delighted to see an effect of SomatoKine treatment
on functional parameters such as `rising from an armless chair' as well as
improvements in grip strength," said Steven Boonen, M.D., Ph.D., principal
investigator in the Celtrix study and a member of the Department of Internal
Medicine at the University Hospital Leuven, Belgium. "Both parameters are
clinically relevant as they have been shown to be predictive of hip fracture."
Addressing Major Medical Needs
Hip fracture patients annually total about 300,000 in the United States
and a comparable number in Europe, and this group is expected to increase
substantially with the rapidly aging population. These patients are a subset of
the 1,500,000 fractures which occur annually in the United States due to severe
osteoporosis. An estimated 24,000,000 people suffer from osteoporosis in the
United States. SomatoKine findings not only provide encouragement for recovery
from hip fracture surgery; they also represent a significant path for the
potential treatment of severe osteoporosis.
Hip fracture leads to severely compromised mobility and lack of
functional independence. Not only is the cost of health care and rehabilitation
high, but the rapid deterioration of the patient's physical condition threatens
recovery and quality of life. Hip bone mineral density, grip strength and the
ability to rise from a sitting position are all known to be strong predictors of
fracture risk. Celtrix's goal is to provide short-term treatment with SomatoKine
to build bone and muscle strength, restore mobility, and increase the patient's
functional independence.
The findings from this feasibility study will be important in designing
a full-scale Phase II trial for recovery from hip fracture surgery as well as in
initiating clinical studies for the treatment of severe osteoporosis. Before
initiating these studies, however, Celtrix intends to establish corporate
partnership(s) for the continued global development of SomatoKine for treatment
of hip fracture surgery and osteoporosis.
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"Celtrix's SomatoKine Demonstrates Positive Effects in Patients Recovering
from Hip Fractures Caused by Severe Osteoporosis"
Page 3
The SomatoKine Complex
SomatoKine is the recombinant equivalent of the natural complex,
IGF-BP3, formed by the anabolic hormone insulin-like growth factor-I (IGF) and
its major regulatory binding protein (BP3). Following hip fracture, blood levels
of IGF-BP3 drop substantially, and patients begin losing bone and muscle mass.
The unique feature of SomatoKine is that it has a role in the metabolism of both
bone and muscle. Administration of SomatoKine establishes a circulating
reservoir of the IGF-BP3 complex that is proving safe and effective in clinical
research.
Clinical Study Overview
The multi-center, Phase II clinical feasibility study with SomatoKine
was conducted in Belgium. It was designed to measure a number of parameters
believed to be of significance in treating patients recovering from hip fracture
surgery. This traumatic injury is most often the result of severe osteoporosis.
The randomized, placebo-controlled and double-blinded trial involved 26 women,
average age of 76, who have undergone hip fracture surgery. The study
participants were randomized into three groups, receiving either a placebo, 0.5
mg/kg per day or a 1.0 mg/kg per day dose of SomatoKine, all administered by
subcutaneous infusion through a portable minipump. Treatment was administered
continuously for a total of eight weeks immediately following hip fracture
surgery. Parameters being evaluated included changes in body composition as
measured by dual-energy x-ray absorptiometry, markers of bone metabolism,
activities of daily living, and other parameters relevant for the assessment of
recovery from hip fracture surgery and measures of osteoporosis, in general. No
drug related adverse events were reported.
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 is also currently undergoing Phase II clinical testing for the
treatment of 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 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 for recovery from hip fracture surgery and the initiation of
trials for osteoporosis, that the results of this small feasibility study for
recovery from hip fracture surgery will continue to show the same observations,
or that there will 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.
-end-
