Phase III Trial of Oral Cladribine, a Novel Investigational Therapy for Multiple Sclerosis, Begins in the United States
04 May 2006 - 11:17PM
PR Newswire (US)
Nationwide Recruitment Begins at Sites Across the U.S. ROCKLAND,
Mass. and GENEVA, May 4 /PRNewswire-FirstCall/ -- Serono (virt-x:
SEO and NYSE: SRA) announced today that recruitment in the U.S. is
beginning for the Phase III CLARITY study (CLAdRIbine Tablets in
Treating MS OrallY Study) of oral cladribine for the treatment of
patients with relapsing forms of multiple sclerosis (MS). This
multi-national study was successfully initiated outside the U.S. in
2005, and will now expand to include 17 clinical trial sites in the
U.S. The study is one of the largest MS trials ever conducted, and
enrollment is on track to be completed in 2006. CLARITY is a
two-year, double-blind, placebo-controlled Phase III study of more
than 1,200 patients. It is designed to assess patients' clinical
relapses, disability progression and MRI (magnetic resonance
imaging) brain activity. Previous clinical trials using cladribine
administered by injection in patients with MS showed positive
effects in reduction of new lesion development in the brain as seen
on MRI scans; reductions in relapses were also observed. "The Phase
III CLARITY trial is enrolling at a strong pace, and the addition
of US sites will accelerate this pace and bring us one step closer
to our goal of making the first oral MS therapy available for
people living with this debilitating condition, underscoring our
fundamental and long-term commitment to the MS community," said Dr.
Paul Lammers, Chief Medical Officer at Serono, Inc. "The
formulation of oral cladribine, combined with the proposed short
dosing regimen, should help patients to be more compliant with
their MS therapy and lighten the patient's treatment burden
associated with chronic MS." "We all are looking forward to the day
when there is an FDA approved oral therapy that can affect the
underlying disease process in MS," said Dr. John Richert vice
president research and clinical programs at the National MS
Society. "Clinical studies, such as CLARITY, are an important part
of the process leading to the development of these new medications.
Those interested in determining whether they are eligible to
participate in the clinical trial should speak with their
healthcare provider." Trial Recruitment Taking Place in 15 States
Currently, there are 17 clinics, medical centers, universities and
hospitals recruiting patients to participate in the study in 15
major cities across the country, including: * Medford, OR * Ann
Arbor, MI * Newark, NJ * Oklahoma City, OK * Boulder, CO *
Charleston, SC * Las Vegas, NV * Columbus, OH * Fort Wayne, IN *
Chicago, IL * Durham, NC * Edmonds, WA * Baltimore, MD * Atlanta,
GA * Charleston, WV Further clinical trial site information is
available at http://www.theclaritystudy.com/, or the U.S. National
Institutes of Health clinical trial information website at
http://www.clinicaltrials.gov/. "We are excited to further evaluate
oral cladribine for the treatment of MS," said Dr. Dusan Stefoski,
M.D., associate professor of the Rush Multiple Sclerosis Center and
a clinical investigator for the CLARITY trial. "From my clinical
experience, the addition of an oral therapy for MS could improve
compliance among patients and potentially change the MS treatment
paradigm." It is estimated that approximately 400,000 Americans are
affected with MS, a chronic, progressive autoimmune disease of the
central nervous system (CNS). Relapsing forms of MS are the most
common. While symptoms of MS are unpredictable and can vary, the
most common symptoms of MS include blurred vision, numbness or
tingling in the limbs and problems with strength and coordination.
About Oral Cladribine Oral cladribine is a proprietary oral tablet
formulation of cladribine that is being studied in an effort to
demonstrate possible benefits as a treatment for patients with
relapsing forms of MS. Cladribine is a purine nucleoside analogue
that interferes with the behavior and the proliferation of certain
white blood cells, particularly lymphocytes, which are involved in
the pathological process of MS. Through its differentiated
mechanism of action, cladribine tablets may offer an effective new
option to patients with MS. About Serono Neurology Currently,
Serono has two therapies available for the treatment of MS: Rebif
(interferon beta-1a), indicated for relapsing forms of MS, and
Novantrone (mitoxantrone for injection concentrate), the only
therapy approved for worsening forms of MS. Full prescribing
information for these products can be obtained by contacting Serono
or visiting the Serono website at http://www.seronousa.com/.
Additional therapy options beyond cladribine tablets are currently
under development at Serono, including osteopontin, an MMP-12
inhibitor, a JNK inhibitor and interferon beta:Fc, in early-stage
development for MS. Serono also is taking a leading role in
developing an understanding of the role of genetics in MS, with a
whole genome scan currently underway. To- date, 80 genes associated
with MS have been identified, based on a 40% scan. The project is
due to be completed in 2006 and will improve understanding of the
causes of MS and the appropriate therapeutic targets for the
disease. Some of the statements in this press release are forward
looking. Such statements are inherently subject to known and
unknown risks, uncertainties and other factors that may cause
actual results, performance or achievements of Serono S.A. and
affiliates to be materially different from those expected or
anticipated in the forward-looking statements. Forward-looking
statements are based on Serono's current expectations and
assumptions, which may be affected by a number of factors,
including those discussed in this press release and more fully
described in Serono's Annual Report on Form 20-F filed with the
U.S. Securities and Exchange Commission on February 28, 2006. These
factors include any failure or delay in Serono's ability to develop
new products, any failure to receive anticipated regulatory
approvals, any problems in commercializing current products as a
result of competition or other factors, our ability to obtain
reimbursement coverage for our products, the outcome of government
investigations and litigation and government regulations limiting
our ability to sell our products. Serono has no responsibility to
update the forward-looking statements contained in this press
release to reflect events or circumstances occurring after the date
of this press release. About Serono Serono is a global
biotechnology leader. The Company has seven biotechnology products
in the U.S., Rebif(R) (interferon beta-1a), Gonal-f(R) (follitropin
alfa for injection), Luveris(R) (lutropin alfa), Ovidrel PreFilled
Syringe(R)/Ovitrelle(R) (choriogonadotropin alfa injection),
Serostim(R) [somatropin (rDNA origin) for injection], Saizen(R)
[somatropin (rDNA origin) for injection] and Zorbtive(TM)
[somatropin (rDNA origin) for injection].(1) In addition to being
the world leader in reproductive health, Serono has strong market
positions in neurology, metabolism and growth and has recently
entered the psoriasis area. The Company's research programs are
focused on growing these businesses and on establishing new
therapeutic areas, including oncology and autoimmune diseases.
Currently, there are more than 25 on-going development projects. In
2005, Serono, whose products are sold in over 90 countries,
achieved worldwide revenues of US$2,586.4 million. Reported net
loss in 2005 was US$106.1 million, reflecting a charge of US$725
million taken relating to the settlement of the US Attorney's
Office investigation of Serostim. Excluding this charge as well as
other non-recurring items, adjusted net income grew 28.4% to
US$565.3 million in 2005. Bearer shares of Serono S.A., the holding
company, are traded on the virt-x (SEO) and its American Depositary
Shares are traded on the New York Stock Exchange (SRA). (1) Package
inserts for Serono's US marketed products are available at
http://www.seronousa.com/ or by calling 1-888-275-7376. DATASOURCE:
Serono CONTACT: Media Relations, USA: +1-781-681-2719, Fax:
+1-781-681-2928, or Investor Relations, USA: +1-781-681-2552, Fax:
+1-781-681-2912 Web site: http://www.theclaritystudy.com/
http://www.clinicaltrials.gov/ http://www.seronousa.com/
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