<PAGE> 1
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: February 25, 1999
Commission File Number: 0-18976
CELTRIX PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
<TABLE>
<S> <C>
DELAWARE 94-3121462
(State or other jurisdiction (I.R.S. Employer Identification No.)
of incorporation or organization)
</TABLE>
2033 Gateway Place, Suite 600, San Jose, CA 95110
(Address of principal executive offices and zip code)
Registrant's Telephone Number: (408) 988-2500
<PAGE> 2
ITEM 5. OTHER EVENTS
On February 25, 1999, Celtrix Pharmaceuticals, Inc., a Delaware corporation
(the "Company") announced Celtrix's SomatoKine(R) Demonstrates Positive Effects
in Diabetes Patients. Further details regarding this announcement are contained
in the Company's news release dated February 25, 1999, attached as exhibit
hereto and incorporated by reference herein.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
(A) EXHIBITS
<TABLE>
<S> <C>
Exhibit 21 Celtrix Pharmaceuticals, Inc. News Release dated February 25, 1999.
</TABLE>
<PAGE> 3
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: February 25, 1999 By: /s/ DONALD D. HUFFMAN
----------------------------------------
Donald D. Huffman
Vice President, Finance & Administration
Chief Financial Officer
(Duly authorized principal financial
and accounting officer.)
<PAGE> 4
CELTRIX PHARMACEUTICALS, INC.
INDEX TO EXHIBITS
<TABLE>
<CAPTION>
Exhibit Number
- --------------
<S> <C>
Exhibit 21 Celtrix Pharmaceuticals, Inc. Press Release dated February 25, 1999.
</TABLE>
<PAGE> 1
EXHIBIT 21
[CELTRIX LETTERHEAD]
NEWS RELEASE
CONTACT: Andreas Sommer, Ph.D.
President and Chief Executive Officer
(408) 988-2500
CELTRIX'S SOMATOKINE(R) DEMONSTRATES POSITIVE EFFECTS
IN DIABETES PATIENTS
INSULIN USAGE LOWERED BY 49% -- IMPROVED GLYCEMIC CONTROL
SAN JOSE, CA - February 25, 1999 -- Celtrix Pharmaceuticals, Inc. (Nasdaq:
CTRX) announced today the results of its Phase IIA clinical trial in patients
with Type 1 diabetes. The final data reveal significant treatment results in
several key measurements: in patients who received SomatoKine(R) (IGF-I/BP3)
treatment, the average daily insulin requirement decreased by 49% and average
daily blood glucose levels decreased by 23% from the levels associated with
conventional insulin therapy. SomatoKine also demonstrated that total serum
cholesterol was reduced by 12%.
"We are extremely pleased to achieve statistically significant results in
such an important indication," commented Andreas Sommer, Ph.D., Celtrix's
president and chief executive officer. "SomatoKine treatment was well tolerated
and patients responded quickly and positively. The findings from this study
clearly reveal the ability of SomatoKine to substantially increase the body's
sensitivity to insulin. Patients suffering from diabetes often experience
difficulties achieving good glycemic control and intensified insulin therapy may
increase the risk of vascular complications and weight gain."
Principal investigators for the study were David R. Clemmons, M.D., Ph.D.,
Professor & Division Chief, Division of Endocrinology, University of North
Carolina School of Medicine and Alan Moses, M.D., Chief Medical Officer of the
Joslin Diabetes Center and Associate Professor of Medicine, Harvard Medical
School. Detailed study results will be presented by the principal investigators
at appropriate scientific meetings later this year.
"These results present a strong case that SomatoKine is reducing insulin
resistance significantly," said Dr. Clemmons. "Another striking finding is the
lack of side effects, which is impressive. SomatoKine, as an adjunct to insulin
therapy, may have a unique role in the treatment of a large number of Type 1 and
Type 2 diabetics suffering from insulin resistance and hyperglycemia, including
patients that fail to respond to oral hypoglycemic therapy to control their
blood sugar. The drug has performed as we expected, potentially offering an
important therapy in managing diabetes and potentially avoiding the
complications which ultimately accompany the disease."
-more-
<PAGE> 2
"Celtrix's SomatoKine(R) Demonstrates Positive Effects in Diabetes Patients"
Page 2
"The known interactions of IGF-I, insulin and growth hormone, as well as
existing clinical data, provide a good rationale for SomatoKine as an adjunct
treatment to intensive high dose insulin therapy," added Dr. Moses. "The
SomatoKine technology seems to have the advantage of delivering therapeutic dose
levels without the known side effects encountered when using IGF-I in the
absence of the regulatory binding protein BP3. The naturally occurring binding
protein, BP3, is known to play an important role in the regulation of
bioavailability and biodistribution of IGF-I."
THE TRIAL
The double-blinded, placebo-controlled, multi-center study involved the
treatment of 12 Type 1 patients in a crossover design, allowing patients to
serve as their own control. Each patient was asked to manage blood glucose
levels in the customary manner by measuring blood glucose several times daily
and by adjusting the injected insulin dosage accordingly. After a two week
run-in period (conventional insulin therapy), patients received either placebo
or SomatoKine (2mg/kg, subcutaneous infusion by mini pump) for two weeks
followed by a three week washout period. Finally, patients received a further
two week treatment with either placebo or SomatoKine in a crossover fashion.
All patients receiving SomatoKine noted a decrease in insulin requirements.
The accuracy of the insulin diaries submitted by the patients was confirmed by
measuring free insulin in the blood circulation, which was reduced by 47% in
patients receiving SomatoKine. Growth hormone, known to substantially contribute
to insulin resistance, was reduced by 77% in patients receiving SomatoKine.
ADDRESSING MAJOR MEDICAL NEEDS
Diabetes is a disease in which the body does not produce or properly use
insulin, a hormone that is needed to convert sugar, starches and other food into
energy. Diabetes affects over 5% of the populations of North America, Europe and
Japan. In the United States alone, the American Diabetes Association estimates
10.3 million people have been diagnosed with the disease, and it is the seventh
leading cause of death. Approximately 5% of patients with diabetes have Type 1
diabetes, the type treated in this study.
Diabetes is associated with a number of life-threatening complications
including heart disease and stroke, kidney disease, blindness, nervous disorders
and circulatory problems that can lead to amputations. As a result, it is one of
the most costly health problems in America, with medical expenses related to
treatment of the disease and its complications totaling over $45 billion
annually.
The findings from this feasibility study will be important in designing a
full-scale Phase II trial. Celtrix intends to identify a corporate partner(s)
for the continued worldwide development of SomatoKine for the treatment of
diabetes.
THE SOMATOKINE COMPLEX
SomatoKine is the recombinant equivalent of the natural complex formed by
the hormone insulin-like growth factor-I (IGF-I) and its major regulatory
binding protein (BP3). IGF-I plays multiple roles in diverse biological
processes, including preservation and formation of bone and muscle. IGF-I also
has been demonstrated to play a key role in the
-more-
<PAGE> 3
"Celtrix's SomatoKine(R) Demonstrates Positive Effects in Diabetes Patients"
Page 3
control of blood glucose. BP3 contains biological information important for the
body's natural regulation of IGF-I bioavailability and biodistribution.
Administration of SomatoKine, the IGF-I/BP3 complex, establishes a circulating
reservoir of IGF-I that is proving in clinical research to be both safe and
effective.
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-I/BP3 complex, for treatment of a broad range of metabolic disorders.
Celtrix has recently completed Phase II feasibility trials in severely
osteoporotic patients recovering from hip fracture surgery and patients
undergoing treatment for traumatic burns. 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 diabetes and other indications, that such trials will
continue to show the same observations, including any statistically relevant
results in larger Phase II or Phase III trials, 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-
