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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: May 22, 1996
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 May 22, 1996, Celtrix Pharmaceuticals, Inc., a Delaware corporation
(the "Company") announced initation of human clinical testing of SomatoKine(R),
its novel IGF-BP3 complex. Further details regarding this announcement are
contained in the Company's news release dated May 22, 1996, 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 May 22, 1996.
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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: May 22, 1996 By: /s/ MARY ANNE RIBI
----------------------
Mary Anne Ribi
Vice President, Finance & Administration
and Chief Financial Officer (Duly
authorized principal financial and
accounting 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 May 22, 1996.
</TABLE>
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[CELTRIX LETTERHEAD]
NEWS RELEASE
CONTACT: Mary Anne Ribi
Vice President and Chief Financial Officer
(408) 988-2500
CELTRIX INITIATES HUMAN CLINICAL TESTING OF
SOMATOKINE(R), ITS NOVEL IGF-BP3 COMPLEX
SANTA CLARA, CA -- May 22, 1996 -- Celtrix Pharmaceuticals, Inc.
(Nasdaq: CTRX) announced today that it has initiated Phase I human clinical
studies of SomatoKine(R), the company's novel complex of insulin-like growth
factor (IGF-I) and its major binding protein (BP3). Celtrix's objective with
these initial clinical studies is to demonstrate that SomatoKine allows for the
safe administration of IGF-I at doses far above what others have been able to
achieve.
"Most naturally occurring IGF-I circulates in the body complexed with
BP3 and plays a key role in diverse biological processes, including tissue
repair, organ function, and muscle and bone formation," said Andreas Sommer,
Ph.D., Celtrix's president and chief executive officer. "Because of its
importance in human health, IGF-I has been evaluated for some time both
preclinically and clinically by academic and industry scientists for a variety
of therapeutic indications. However, limitations associated with using free
(unbound) IGF-I have proven significant: acute insulin effects (such as
hypoglycemia), suppression of growth hormone secretion, short circulating half
life, and limited and transient efficacy at safe dosage levels."
"When IGF-I is bound to BP3, as it is in nature, it does not display
these limitations," Dr. Sommer said. "Furthermore, BP3 is important in the
regulation of the release of IGF-I to target tissue sites, where the hormone is
active only when needed."
"As demonstrated in preclinical testing, the SomatoKine complex of
IGF-BP3 appears to substantially overcome the known dose-limiting, acute side
effects observed upon administration of free IGF-I and should thus allow
significantly expanded dosing regimens," Dr. Sommer said. "This ability to
safely administer higher doses of IGF-I has revealed efficacies in preclinical
testing that could not be achieved with free IGF-I at safe dosage levels. In
addition, IGF-I administered as SomatoKine displays a significantly longer
circulating half life, which could reduce the need for frequent administration."
Two Phase I studies of SomatoKine are being conducted: an open-label,
single-dose-escalation study and a randomized, double-blind, placebo-controlled,
multiple-dose-escalation study. Designed to identify the tolerated dosage range
for SomatoKine in humans, these studies will involve a total of up to 36 healthy
men and woman, ages 18-60. The Phase I studies are expected to pave the way for
the initiation of Phase II efficacy studies later this fiscal year.
Celtrix's near-term goal with SomatoKine is hormone replacement therapy
for acute conditions, such as major surgery, organ damage/failure and traumatic
injury. These conditions frequently involve abnormally low blood levels of
IGF-BP3 that are associated with
-more-
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"Celtrix Initiates Human Clinical Testing of SomatoKine(R), its Novel IGF-BP3
Complex"
Page 2
a dangerous catabolic state in which the body poorly utilizes nutrients and
breaks down muscle (even heart muscle, in severe cases) for energy. The
inability of damaged tissue to rapidly heal, aggravated in some cases by a
compromised immune system, increases the risk of serious infection and delays
restoration of organ and body function. Lost strength and mobility also may
require extended hospitalization, intravenous medication, surgery and
rehabilitation procedures.
"We believe hormone replacement therapy with SomatoKine could make a
significant difference in the patient's recovery and quality of life," Dr.
Sommer said. "The medical need is substantial, and potential clinical targets
represent attractive markets estimated at over $1 billion in the United States
alone."
Celtrix is a biopharmaceutical company developing novel therapeutics
for seriously debilitating, degenerative conditions primarily associated with
severe trauma, chronic diseases or aging. Company programs are focused on the
use of SomatoKine, a novel IGF-BP3 complex, to treat destructive metabolic
processes (catabolism) in acute indications such as major surgery, organ
damage/failure and traumatic injury. Potential chronic indications could include
osteoporosis, chronic renal (kidney) failure, and wasting conditions associated
with cancer and AIDS. Through strategic alliances with Celtrix, The Green Cross
Corporation 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 press 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 future company 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 release.
-end-
