-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, ES6BXeHQ2y9W7zQZFe5mX2esfAdXP2lz93YbsBiPV7HyT41xb+RwzAD+CFqzYh4I hHX4PAe0DQJY//tvI8ql7w== 0000891618-98-005093.txt : 19981124 0000891618-98-005093.hdr.sgml : 19981124 ACCESSION NUMBER: 0000891618-98-005093 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19981119 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 19981123 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CELTRIX PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000871395 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943121462 STATE OF INCORPORATION: DE FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 000-18976 FILM NUMBER: 98757104 BUSINESS ADDRESS: STREET 1: 3055 PATRICK HENRY DR CITY: SANTA CLARA STATE: CA ZIP: 95054 BUSINESS PHONE: 4089882500 MAIL ADDRESS: STREET 2: 3055 PATRICK HENRY DRIVE CITY: SANTA CLARA STATE: CA ZIP: 95054 FORMER COMPANY: FORMER CONFORMED NAME: CELTRIX LABORATORIES INC DATE OF NAME CHANGE: 19600201 8-K 1 FORM 8-K 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: November 19, 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 2 ITEM 5. OTHER EVENTS On November 19, 1998, Celtrix Pharmaceuticals, Inc., a Delaware corporation (the "Company") announced Celtrix's SomatoKine(R) Improves Cardiac Function In Victims of Burn Trauma. Further details regarding this announcement are contained in the Company's news release dated November 19, 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 November 19, 1998. 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: November 19, 1998 By: /s/ DONALD D. HUFFMAN ---------------------------------------- Donald D. Huffman Vice President, Finance & Administration Chief Financial Officer (Duly authorized principal financial and accounting officer.) 4 CELTRIX PHARMACEUTICALS, INC. INDEX TO EXHIBITS Exhibit Number Exhibit 21 Celtrix Pharmaceuticals, Inc. Press Release dated November 19, 1998.
EX-21 2 CELTRIX PHARMACEUTICALS, INC. PRESS RELEASE 1 EXHIBIT 21 NEWS RELEASE CONTACT: Andreas Sommer, Ph.D. President and Chief Executive Officer (408) 450-5503 CELTRIX'S SOMATOKINE(R) IMPROVES CARDIAC FUNCTION IN VICTIMS OF BURN TRAUMA RESULTS HAVE POTENTIAL WIDESPREAD APPLICATION FOR HEART PATIENTS SANTA CLARA, CA -- November 19, 1998 -- Celtrix Pharmaceuticals, Inc. (Nasdaq: CTRX) announced that data presented at the American Heart Association Conference in Dallas, TX, show statistically significant effects of SomatoKine(R) treatment on cardiac function in burn trauma patients. Following severe burn injury, heart and circulatory functional changes occur including relative depression of heart function. This in turn may lead to inadequate blood supply to other parts of the body. Inadequate blood supply can result in tissue damage, organ failure, shock and ultimately death. J. Rai, M.D. and her colleagues at the Shriners Hospital for Children-University of Texas Medical Branch in Galveston showed that six severely burned children receiving an intravenous infusion of SomatoKine, Celtrix's novel IGF-BP3 compound, for five days, showed a 16% improvement in cardiac output and a 15% increase in stroke volume over saline-treated controls. Other patients treated with different dose levels showed a lesser response. No side effects were noted and the observed improvements were not accompanied by undesirable increases in left ventricular wall thickness or increased oxygen consumption by the heart muscle. "Although anabolic agents such as insulin-like growth factor-I (IGF-I) have been known to attenuate cardiac dysfunction after severe burn trauma, the use of these agents in burn therapy has been complicated by systemic side effects such as hypoglycemia," commented Dr. Jyoti Rai, principal investigator. "On the other hand, SomatoKine (IGF-I complexed to its major binding protein, BP-3) has demonstrated efficacy and an impressive safety profile." "This degree of improvement in heart function is sufficient to potentially improve overall outcomes in patients with cardiac dysfunction in association with large burns. In addition, this may also be beneficial to patients with acute or chronic cardiac dysfunction in a variety of disease states, including other forms of trauma and chronic congestive heart failure," stated Martin E. Sanders, M.D., medical consultant to Celtrix for this study. Andreas Sommer, Ph.D., Celtrix's president and chief executive officer, added, "These data are the latest findings from our Phase II clinical trials involving patients with severe burns. They are further indication of SomatoKine's multi-functional activity in counterbalancing adverse conditions induced by trauma. We have reported previously on the drug's ability to reverse the catabolic condition which leads to degradation of muscle tissue and its positive effect on the immune system." -more- 2 "Celtrix's SomatoKine Improves Cardiac Function in Victims of Burn Trauma" Page 2 CELTRIX PHARMACEUTICALS 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 currently undergoing Phase II clinical testing for the treatment of severe osteoporosis (recovery from hip fracture surgery), 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 21 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 outcomes of future clinical trials involving SomatoKine and the ability to enter into collaboration(s) with corporate partners, 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-
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