Healthcare Industry News: Ipsen
News Release - June 16, 2008
Tercica Announces Results from Increlex(R) IGFD Patient Registry and Other Increlex(R) Studies at the 90th Meeting of the Endocrine Society
Safety and Improved One-Year Growth Rates for Registry Patients Treated with Increlex(R) at Higher DosesFirst Analysis of Safety Events Reported from a Prospective Trial Evaluating Increlex(R) Treatment in Children with Primary IGFD
Prevalence of Primary IGFD Reported from a Prospective Study of Patients Presenting to Pediatric Endocrinologists with Short Stature
Tercica Also Announces Launch of the Somatuline(R) Depot Observational Study (SODA) for Patients with Acromegaly
BRISBANE, Calif.--(HSMN NewsFeed)--Tercica, Inc. (NASDAQ: TRCA ) today announced the first results from the Increlex® Growth Forum Database (IGFD) Registry in two posters presented at the 90th annual meeting of the Endocrine Society in San Francisco. Increlex® (mecasermin (rDNA origin) injection) is currently approved in the United States for the treatment of severe Primary IGF-1 Deficiency.
“Data from the IGFD Registry showed that children treated with Increlex® at the higher end of the recommended-dose range (= 100 µg/kg twice daily) had better growth rates than children treated with lower doses,” said Sandra L. Blethen, M.D., Ph.D., Vice President, Medical Affairs at Tercica. “In addition, these data showed adverse events were not dose-related, and thus emphasize the importance of treating children with severe Primary IGFD using adequate doses of Increlex®,” Dr. Blethen added. The two posters describing these results being displayed on June 16 during the Poster Session “CLINICAL - Growth Deficiency: Cause & Treatment” are titled:
- The Growth Response to Insulin-Like Growth Factor-1 Treatment during the First Year of Therapy in Prepubertal Children Is Dependent on Mean Increlex® Dose. [Poster #P2-563] AJ Cohen, R Levy, S Blethen, J Kuntze, J Hertz, J Frane, The Endocrine Clin PC, Memphis, TN; Rush Presbyterian St Luke's Med Ctr, Chicago, IL; Tercica, Brisbane, CA; Santa Monica, CA
- Safety of Increlex® Treatment in the IGFD Registry. [Poster #P2-564] J Kuntze, S Franklin, J Hertz, J Frane, S Blethen, Tercica, Brisbane, CA; Connecticut Children's Med Ctr, Hartford, CT; Pediatric Endocrinology of San Diego Med Group, San Diego, CA; Santa Monica, CA
The IGFD Registry began enrolling patients in the Web-based program in May 2006, and allows physicians to register and enter information on a real-time basis. Increlex® was studied in children with short stature and low IGF-1 levels not associated with growth-hormone deficiency. The efficacy analysis presented is based on the height velocity of 36 pre-pubertal children who were tracked for 12 months. The children were split into two groups with one group receiving doses greater than 100 µg/kg BID (mean dose 115 µg/kg) and a second group receiving doses below 100 µg/kg BID (mean dose 60 µg/kg). There were no significant differences in the baseline characteristics of the two groups in terms of their initial height, their parents’ height, their levels of growth hormone or their levels of IGF-1. The safety data presented are based on 237 patients who were followed for a total of 158 patient years. The safety analysis found no statistically significant relationship between dose and adverse events. No new safety signals or unexpected serious adverse events occurred.
First Analysis of Safety Events from a Prospective Trial Evaluating Increlex® Treatment in Children with Primary IGFD
Tercica also announced the results of the first safety analysis from an ongoing, 12-month, multi-center, open-label clinical trial (study MS-301) comparing twice-daily Increlex® treatment (40, 80, 120 µg/kg) with observation-only in children with growth failure due to Primary IGFD. Primary IGFD was defined as height and IGF-1 standard deviation scores of <-2, and maximally stimulated serum growth-hormone levels of = 7 ng/mL. The results, from a cohort of 111 patients who had completed 101 patient years of active treatment with Increlex® and 25 patients who had completed 23 patient years of untreated observation, showed that adverse events were generally mild, transient, manageable and usually resolved without dose reduction. Hypoglycemia was not dose-related, and occurred in 14% of treated and 8% of untreated subjects.
The poster describing these results and being displayed on June 16 during the Poster Session “CLINICAL - Growth Deficiency: Cause & Treatment” is titled:
- Analysis of Safety Events in Clinical Trials of rhIGF-1 Replacement Therapy in Children with IGF-1 Deficiency. [Poster #P2-565] A. Rogol, J. Frane, T. von Stein, and G.M. Bright, University of Virginia Charlottesville, VA, Riley Hospital, Indiana University School of Medicine, Indianapolis, IN, Santa Monica, CA, and Tercica, Brisbane, CA
Prevalence of Primary IGFD Reported in a Prospective Study of Patients Presenting to Pediatric Endocrinologists with Short Stature
Tercica also announced that data from a prospective, multi-center study showed that Primary IGFD, defined as height and IGF-1 standard deviation scores of <-2 and stimulated growth-hormone serum levels of = 7 ng/mL, occurred in 26% of 143 children with short stature presenting to one of eight pediatric-endocrine clinics in the United States. The study also showed that growth velocities tended to be lowest among children with the lowest IGF-1 levels, and that IGF-1 status, as assessed by repeat blood sampling, was consistent in 87% of subjects.
The poster describing these results and being displayed on June 16 during the Poster Session “CLINICAL - Growth Deficiency: Cause & Treatment” is titled:
- A Prospective, Multi-center Characterization of Children with Short Stature. [Poster #P2-561] L.K. Midyett, T. Luetjen, L. Deeb, L. Owens, Q. Van Meter, J. Frane and G.M. Bright on behalf of the IGFD Prevalence Study Group, Children’s Mercy Hospital, Kansas City, MO, Children’s Clinic, Tallahassee, FL, Peachtree City GA, Santa Monica CA, and Tercica, Brisbane, CA
Tercica Launches Observational Study for Patients with Acromegaly
Additionally, Tercica also announced today that the Company has launched a post-marketing observational study for patients with Acromegaly (MS319), titled “Somatuline® Depot (lanreotide) Injection for Acromegaly (SODA)”. Somatuline® Depot is currently approved in the United States for the long-term treatment of acromegalic patients who have had an inadequate response to, or cannot be treated with, surgery and/or radiotherapy.
In this multi-center, open-label observational study, patients with a clinical diagnosis of acromegaly who are prescribed Somatuline® Depot will be followed for two years. Data generated from the study will be reported to participating investigators at various intervals throughout the study. Information regarding this study may be obtained at “clinicaltrials.gov” or at 1-866-TERCICA (837-2422).
About Increlex® (mecasermin (rDNA origin) injection)
The active ingredient of Increlex® is recombinant human insulin-like growth factor-1 (IGF-1). IGF-1 is the direct mediator of growth hormone's (GH) effect on statural growth, and must be present for normal growth of bones and cartilage in children. In Primary IGFD, children's serum IGF-1 levels are low, despite the presence of a normal or elevated GH level. Without adequate IGF-1, children cannot achieve normal height. In children with this disorder, low IGF-1 levels are due to growth-hormone resistance associated with mutations in GH receptors, post-GH receptor signaling pathways, or to defects in IGF-1 gene expression. As such, these children cannot be expected to respond adequately to exogenous GH treatment. Some individuals may also have a range of metabolic disorders, including lipid abnormalities, decreased bone density, obesity and insulin resistance.
The most common side effects of Increlex® use are headache and hypoglycemia. There is also a possibility of enlarged tonsils and allergic reaction.
Increlex® has been marketed in the United States by Tercica since early 2006 for the treatment of children with severe Primary IGFD. Severe Primary IGFD is defined by height and IGF-1 levels at least three standard deviations below the mean for age and sex, and presence of normal or elevated GH level. Exclusive rights to develop and commercialize Increlex® were licensed to Ipsen in October 2006 for all regions of the world except the United States, Japan, Canada, Taiwan and certain countries of the Middle East and North Africa.
About Somatuline® Depot
Somatuline® Depot (also marketed as Somatuline® Autogel® outside the United States) is a sustained-release formulation for injection containing lanreotide, a somatostatin analogue (a hormone that inhibits the release of growth hormone). Somatuline® Depot was initially developed and continues to be used mainly in the treatment of acromegaly, a disorder caused by the overproduction of growth hormone or prolactin due to a benign tumor of the anterior pituitary gland. This product subsequently underwent further development in Europe in the treatment of symptoms associated with neuroendocrine tumors (particularly of a carcinoid type). Ipsen believes that the Somatuline® Depot formulation, to which it holds the patent, represents a major technological advance. As far as Ipsen is aware, this represents the first semi-solid formulation for injection without any excipient, since the active substance itself controls the sustained release. Somatuline® Depot releases the active substance with no excipient other than water during a period of at least 28 days, thus requiring just one injection per month, compared with the two or three injections previously necessary. This product is presented in a pre-filled syringe for easier administration.
Somatuline® Depot has been marketed in the United States by Tercica since August 2007 for the long-term treatment of acromegalic patients who have had an inadequate response to, or cannot be treated with, surgery and/or radiotherapy. The effect of Somatuline® Depot on reducing growth hormone and IGF-levels and control of symptoms in patients with acromegaly was studied in two long-term, multiple-dose, randomized, multi-center studies performed in the United States and in Europe. Somatuline® Depot demonstrated its ability to decrease the levels of growth hormone and IGF-1 in the majority of patients over a one-year period.
About Tercica
Tercica is a biopharmaceutical company committed to improving endocrine health by partnering with the endocrine community to develop and commercialize new therapeutics for pediatric and adult growth disorders, and for adult metabolic disorders. For further information on Tercica, please visit www.tercica.com.
Source: Tercica
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