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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: March 26, 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 March 26, 1998, Celtrix Pharmaceuticals, Inc., a Delaware corporation
(the "Company") reported interim results of Phase II clinical feasibility study
using SomatoKine(R) for recovery from hip fracture surgery. Further details
regarding this announcement are contained in the Company's news release dated
March 26, 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 March 26, 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: March 26, 1998 By: /s/ ANDREAS SOMMER
-------------------------------------
Andreas Sommer
President and Chief Executive 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 March 26, 1998.
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EXHIBIT 21
[CELTRIX LETTERHEAD]
NEWS RELEASE
CONTACT: Andreas Sommer, Ph.D.
President and Chief Executive Officer
(408) 988-2500
CELTRIX REPORTS INTERIM RESULTS OF PHASE II
CLINICAL FEASIBILITY STUDY USING SOMATOKINE(R)
FOR RECOVERY FROM HIP FRACTURE SURGERY
POTENTIALLY IMPORTANT TRENDS OBSERVED FOR SOMATOKINE'S EFFECT ON HIP
BONE MINERAL DENSITY, HAND GRIP STRENGTH AND FAT BODY MASS
SANTA CLARA, CA -- March 26, 1998 -- Celtrix Pharmaceuticals, Inc.
(Nasdaq: CTRX) today reported interim results from its Phase II clinical
feasibility study using SomatoKine(R), its novel IGF-BP3 complex, in the
treatment of hip fracture surgery patients. The multi-center study, conducted in
Belgium, is designed to measure a number of parameters believed to be of
significance to hip fracture patients. It is randomized, placebo-controlled and
double-blinded.
"Although the Phase II feasibility study is small and not intended to be
statistically significant, we are seeing potentially important trends with
SomatoKine," said Andreas Sommer, Ph.D., Celtrix's president and chief executive
officer. "One of the most encouraging observations to date is the positive
effect of SomatoKine on hip bone mineral density, a strong predictor of reduced
refracture risk."
"Hip fracture patients typically suffer an accelerated loss of hip bone
mineral density, which predisposes them to a high risk of refracture," Dr.
Sommer said. "After the characteristic initial loss of hip bone mineral density
following hip fracture surgery, patients treated for eight weeks with 1.0 mg/kg
per day of SomatoKine regained a substantial portion of their hip bone mineral
density. Three months into the study (one month post-treatment), these patients
showed a hip bone mineral density decrease of less than 2% from baseline value.
Patients treated with a lower dose of SomatoKine showed a lesser response.
Placebo-treated patients declined 7% from baseline value. 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%."
"Hand grip strength improved 25% from baseline value for patients
treated with the 1.0 mg/kg dose of SomatoKine versus 7% for those receiving the
placebo," Dr. Sommer said. "Fat body mass decreased 13% from baseline for the
SomatoKine-treated patients and 6% for patients receiving the placebo. Increased
grip strength and reduced fat body mass may indicate improved health and
functionality. No adverse treatment-related side effects have been reported to
date."
Whether the increased grip strength observed in SomatoKine-treated
patients is associated with increased muscle mass remains to be determined.
Preclinical studies suggest that SomatoKine has an effect on building lean body
tissue, but due to the limited size and scope of the feasibility study, this
trend was not as clear in the data analysis. Local effects on muscle may not be
readily apparent when measuring total lean body mass, as done in this study, but
may be reflected in parameters such as grip strength.
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"Celtrix Reports Interim Results of Phase II Clinical Feasibility Study Using
SomatoKine(R) For Recovery From Hip Fracture Surgery"
Page 2
Final patient follow-up and data analysis are anticipated in fourth
quarter 1998. 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
additional corporate partnership(s) for the continued global development of
SomatoKine for treatment of hip fracture surgery and osteoporosis. The company
currently is working with The Green Cross Corporation (now merged with Yoshitomi
Pharmaceutical Industries Ltd.) for the treatment of osteoporosis in Japan.
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. Typically, these patients
suffer from severe osteoporosis, a disorder in which the bones become
increasingly porous, brittle and subject to fracture. For them, the SomatoKine
findings not only provide encouragement for recovery from hip fracture surgery,
they also represent a significant path for the potential treatment of
osteoporosis.
"Recovery from hip fracture surgery can be very difficult and costly,
and restoration of bone mineral density is vital to protecting the patient from
subsequent fractures," said Piet Geusens, M.D., Ph.D., the study's coordinating
principle investigator and Professor of Rheumatology at the Dr. L.
Willems-Instituut in Belgium. "The IGF-BP3 complex, SomatoKine, presumably has a
unique profile in the treatment of patients with recent hip fracture, since
treated patients do not appear to suffer from the general decline normally seen
in bone strength. As a result, SomatoKine therapy holds promise for treatment of
osteoporosis, including the most devastating complication, fracture of the hip."
"In addition to bone mineral density, muscle weakness has been shown to
be a major risk factor for future fractures," said Steven Boonen, M.D., Ph.D.,
principle investigator in the Celtrix study and a member of the Department of
Internal Medicine at University Hospital Leuven in Belgium. "Research also has
shown that muscle strength, including grip strength, correlates with bone
density and physical fitness. Medical therapy which can increase grip strength
therefore may improve both functional independence and the patient's overall
health. The trend that we have observed to date with SomatoKine is encouraging."
THE SOMATOKINE COMPLEX
SomatoKine is the recombinant equivalent of the natural complex formed
by the anabolic hormone insulin-like growth factor-I and its major binding
protein (IGF-BP3 complex). Following hip fracture, blood levels of IGF-BP3 drop
substantially, and patients begin losing bone and lean body mass. In addition,
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. 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.
CLINICAL STUDY OVERVIEW
Celtrix's Phase II clinical feasibility study with SomatoKine involves
24 elderly women, ages 65-90, who have undergone hip fracture surgery. The study
participants were randomized into three groups, receiving either a placebo, or a
0.5 mg/kg per day dose of SomatoKine or a
-more-
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"Celtrix Reports Interim Results of Phase II Clinical Feasibility Study Using
SomatoKine(R) For Recovery From Hip Fracture Surgery"
Page 3
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. Trends being
evaluated include 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.
The feasibility study was designed to demonstrate trends in parameters
which might be most affected by SomatoKine, rather than to establish statistical
significance. Interim data reported today for hip bone mineral density and fat
body mass are based on findings which currently include seven patients per
group, and grip strength data are based on findings which currently include five
patients per group. All data were obtained one month post-treatment (the 12-week
time point in the study). Patient follow-up will continue through the conclusion
of the study at week 24.
ADDITIONAL INFORMATION
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
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 alliances with Celtrix, Yoshitomi
Pharmaceutical Industries Ltd. 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 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 final 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.
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