First patient enrolled in the Kiobrina® phase III study
(Thomson Reuters ONE) -
The first patient has been enrolled in the phase III study with Kiobrina®
(rhBSSL) which is designed to evaluate efficacy, safety and tolerability of
Kiobrina® in the treatment of preterm infants. Kiobrina® is a recombinant
produced human bile-salt stimulated lipase (rhBSSL) developed by Sobi to improve
growth in preterm infants who receive pasteurized breast milk or infant formula.
The phase III study is a multicenter, double- blind, placebo-controlled study
where preterm infants younger than 32 weeks of gestational age are randomized to
receive rhBSSL or placebo added to preterm formula or pasteurized human milk for
4 weeks to demonstrate improved growth velocity. After treatment, there is a
follow up period of 1 year. The trial is expected to enroll patients in 70
centers in 11 European countries.
The objective of this phase III study is to confirm the results from two
previous phase II studies with Kiobrina® (rhBSSL) administered to either formula
or pasteurized milk, respectively. The combined results from the phase II
studies showed a statistically significant increase in growth velocity and
uptake of long chain polyunsaturated fatty acids such as DHA (Docosahexanoic
acid) and AA (Arachidonic acid) (omega-3 and omega-6 fatty acids).
"I am very pleased that the first patient is now included in this trial.
Kiobrina® is a unique project developed by Sobi with a potential to improve
growth and development of preterm infants", says Peter Edman, Ph.D., Chief
Scientific Officer of Sobi.
About Kiobrina®
Native bile-salt-stimulated lipase (BSSL) is a bioactive component of breast
milk important for fat digestion in preterm infants. Kiobrina® is a recombinant
human lipase (rhBSSL) with the same amino acid sequence and properties as the
native BSSL. The rationale for adding rhBSSL to pasteurized breast milk or
infant formula is to restore the natural lipase activity level that is either
lost in pasteurization of breast milk or totally absent in formula and thereby
improve growth velocity in preterm infants.
For additional information, please contact:
-Peter Edman, Chief Scientific Officer, telephone +46 8 697 21 77
-Åsa Stenqvist, VP Communications and IR, telephone +46 8 697 21 88
About Swedish Orphan Biovitrum (Sobi)
Sobi is a leading European specialty pharmaceutical company focused on providing
and developing specialty pharmaceuticals for patients with rare diseases and
significant medical needs. The portfolio comprises about 60 marketed products,
as well as projects in late clinical phase. Key therapeutic areas are
hematological diseases, autoimmune diseases, hereditary metabolic disorders and
therapeutic oncology. In 2010 Sobi had revenues of SEK 1.9 billion and
approximately 500 employees. The share (STO: SOBI) is listed on NASDAQ OMX
Stockholm. For more information please visitwww.sobi.com
The above information has been made public in accordance with the Swedish
Securities Market Act and/or the Financial Instruments Trading Act. The
information was released for public distribution on August 2, 2011 at 8.30 CET.
Sobi Press Release August 2, 2011 - pdf format:
http://hugin.info/134557/R/1535423/468243.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Swedish Orphan Biovitrum AB (publ) via Thomson Reuters ONE
[HUG#1535423]
Unternehmensinformation / Kurzprofil:
Datum: 02.08.2011 - 08:31 Uhr
Sprache: Deutsch
News-ID 56899
Anzahl Zeichen: 4102
contact information:
Town:
Stockholm
Kategorie:
Business News
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"First patient enrolled in the Kiobrina® phase III study"
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