Market Snapshot
  • U.S.
  • Europe
  • Asia
Ticker Volume Price Price Delta
DJIA 16,413.83 -11.02 -0.07%
S&P 500 1,866.12 3.81 0.20%
NASDAQ 4,096.72 10.50 0.26%
Ticker Volume Price Price Delta
STOXX 50 3,155.81 16.55 0.53%
FTSE 100 6,625.25 41.08 0.62%
DAX 9,409.71 91.89 0.99%
Ticker Volume Price Price Delta
NIKKEI 14,417.53 -0.15 -0.00%
TOPIX 1,166.59 0.04 0.00%
HANG SENG 22,760.24 64.23 0.28%

CSL Behring enrolls first patient in global pediatric Phase III pivotal study of recombinant fusion protein linking coagulation



CSL Behring enrolls first patient in global pediatric Phase III pivotal study
   of recombinant fusion protein linking coagulation factor IX with albumin
                        (rIX-FP) to treat hemophilia B

  PR Newswire

  KING OF PRUSSIA, Pennsylvania, Jan. 21, 2013

-- CSL Behring achieves key milestone in PROLONG-9FP program

-- CSL Behring is currently recruiting patients for its Phase III adult and
pediatric trials, the final phase of the PROLONG-9FP clinical trial program

-- CSL Behring presents results of innovative biodistribution study at 54th
American Society of Hematology (ASH) Annual Meeting, supportive of rIX-FP long
half-life data

KING OF PRUSSIA, Pennsylvania, Jan. 21, 2013 /PRNewswire/ -- CSL Behring has
announced that the first patient has been enrolled in the pivotal pediatric
phase III study to evaluate the safety, efficacy and pharmacokinetics of
recombinant fusion protein linking coagulation factor IX with recombinant
albumin (rIX-FP) in previously treated children (up to age 11 years). The
study site for this first enrollment is the Czech Republic.

"CSL continues to advance at a very encouraging rate with our recombinant
coagulation factor development program," said Dr. Andrew Cutherbertson, Chief
Scientist, CSL Limited. "The long history of profound expertise and commitment
CSL brings to developing safe and effective therapies to improve the lives of
those affected by rare and serious bleeding disorders remains the key to our
ongoing success in this therapeutic area. With each clinical milestone we
meet, we draw closer to our goal of bringing another truly innovative new
treatment option to patients."

CSL Behring, in collaboration with its parent company, CSL Limited (ASX:CSL),
is developing rIX-FP through the PROLONG-9FP clinical trial program for the
prophylaxis and treatment of bleeding episodes, including control and
prevention of bleeding in surgical settings in patients with factor IX
deficiency.

Results of a Phase I study evaluating recombinant fusion protein linking
coagulation factor IX with albumin (rIX-FP) in patients with severe hemophilia
B were publicly presented earlier this year and published in BLOOD 2012
showing that rIX-FP achieved a 91.57 hours terminal half-life, incremental
recovery of 1.376 (IU/dL) / (IU/kg), and clearance of 0.75 mL/h/kg. This was
an extension in half-life of 5.3 times that of the current recombinant FIX
therapy.

Innovative Look at Tissue Distribution of rIX-FP Produce Early Results
Presented at ASH

CSL Behring presented data at the American Society of Hematology on the tissue
distribution of rIX-FPthat demonstrated that rIX-FP was detectable five times
longer in the tissues, including the bone. The extent and speed of onset of
tissue penetration were similar for both rIX-FP and the study comparator
product.

"These results demonstrate that rIX-FP was detectable significantly longer
than the study comparator product, though they both behave in essentially the
same way in terms of speed of onset and tissue penetration," said Dr. Stefan
Schulte, Vice President of Research and Development at CSL Behring. "These
results provide further evidence that rIX-FP is an extended half-life
recombinant factor IX with the potential to reduce the number of injections
needed in patients receiving prophylaxis from two or three injections per week
with the study comparator product, to once weekly or significantly less
frequently with rIX-FP. Further, they show that rIX-FP may have the potential
to improve compliance and ease prophylaxis. This may, in turn, improve the
quality of life for people with hemophilia B."

CSL Behring is currently recruiting patients for its adult phase II/III and
pediatric phase III trials, the final phase of the PROLONG-9FP clinical trial
program. More information can be found at www.clinicaltrials.gov .

About Hemophilia Hemophilia is a congenital bleeding disorder characterized by
prolonged or spontaneous bleeding, especially into the muscles, joints, or
internal organs. In nearly all cases, it affects only males. The disease is
caused by deficient or defective blood coagulation proteins known as factor
VIII or IX. The most common form of the disease is hemophilia A, or classic
hemophilia, in which the clotting factor VIII is either deficient or
defective. Hemophilia B is characterized by deficient or defective factor IX.
Hemophilia A affects approximately 1 in 5,000 to 10,000 people. Hemophilia B
affects approximately 1 in 25,000 to 50,000 people. The recommended treatment
for people with hemophilia deficiency is to treat by replacement factor
therapy.

About CSL Behring CSL Behring is a leader in the plasma protein therapeutics
industry. Committed to saving lives and improving the quality of life for
people with rare and serious diseases, the company manufactures and markets a
range of plasma-derived and recombinant therapies worldwide.

CSL Behring therapies are used around the world to treat coagulation disorders
including hemophilia and von Willebrand disease, primary immune deficiencies,
hereditary angioedema and inherited respiratory disease, and neurological
disorders in certain markets. The company's products are also used in cardiac
surgery, organ transplantation, burn treatment and to prevent hemolytic
diseases in the newborn. CSL Behring is a subsidiary of CSL Limited (ASX:CSL),
a biopharmaceutical company with headquarters in Melbourne, Australia. For
more information visit http://www.cslbehring.com . CSL Behring operates one of
the world's largest plasma collection networks, CSL Plasma.

Media Contact: Sheila A. Burke

Director, Worldwide Commercial Operations Communications & Public Relations
CSL Behring 610-878-4209

Website: http://www.cslbehring.com
Sponsored Links
Advertisement
Advertisements
Sponsored Links
Advertisement