EAST HANOVER, N.J.,
Dec. 3, 2016 /PRNewswire/
-- Results from the Phase II SUSTAIN study show that SEG101
(crizanlizumab, formerly SelG1), an anti-P-selectin antibody,
reduced the median annual rate of sickle cell-related pain crises
(SCPC) by 45.3% compared to placebo (1.63 vs 2.98, p=0.010) in
patients with or without hydroxyurea therapy1. Novartis
today announced that the data are being featured in the official
press briefing at the 58th American Society of
Hematology (ASH) Annual Meeting and presented during the Plenary
Scientific Session tomorrow (Abstract #1, 2:00 - 4:00 p.m. PST). The results also are being
published simultaneously in The New England Journal of
Medicine.
"Acute painful episodes, commonly referred to
as vaso-occlusive crises, are a substantial cause of morbidity
in sickle cell disease with limited treatment options," said
Kenneth I. Ataga, M.D., Division of Hematology/Oncology,
University of North Carolina, Chapel
Hill. "These findings show that crizanlizumab significantly
reduces the frequency of painful crises and represents a
potentially novel disease-modifying therapeutic option."
In the SUSTAIN study, patients were assigned to high-dose (5.0
mg/kg), low-dose (2.5 mg/kg) and placebo arms. The study met its
primary endpoint, reduction of the annual rate of SCPC in the
high-dose arm by 45.3% vs. placebo (medians of 1.63 vs. 2.98,
p=0.010). In the low- dose arm, the annual rate of SCPC was reduced
by 32.6% vs. placebo (medians of 2.01 vs. 3.0, p = 0.180). For
patients in the high-dose arm, time to first SCPC vs. placebo was
2.9 times longer (medians of 4.07 vs. 1.38 months, p = 0.001) and
time to second SCPC was 2.0 times longer than placebo (medians of
10.32 vs. 5.09 months, p = 0.022)1.
"Patients have long been in need of a new therapy for treatment
of SCPC, the most common and debilitating complication of sickle
cell disease," said Bruno Strigini, CEO of Novartis Oncology. "We
are pleased that data from the SUSTAIN study show SEG101 may have
the potential to become the first new option for patients dealing
with SCPC since hydroxyurea was approved for use in sickle cell
anemia about 20 years ago2."
Despite its availability, hydroxyurea often is not utilized
primarily due to concerns about patient compliance and potential
adverse events3,4.
About the SUSTAIN trial
The SUSTAIN trial was a multicenter, multinational, randomized,
placebo-controlled, double-blind, 12-month study to assess safety
and efficacy of the anti-P-selectin antibody SEG101 with or without
hydroxyurea therapy in sickle cell disease patients with sickle
cell-related pain crises. Patients included in the study had a
history of 2 to 10 pain crises in the previous 12 months. Patients
receiving hydroxyurea or erythropoietin were included if prescribed
for the preceding 6 months and dose was stable for at least 3
months. The trial randomized 198 patients age 16 to 65 to receive
high-dose SEG101, low-dose SEG101 or placebo1.
Adverse events that occurred in 5% or more of patients in an
active dose group and were elevated over placebo by at least 2-fold
were arthralgia, pruritus, vomiting, chest pain, diarrhea, road
traffic accident, fatigue, myalgia, musculoskeletal chest pain,
abdominal pain, influenza and oropharyngeal pain. There were no
apparent increases in infections with SEG101 treatment. Five deaths
occurred during the study, 2 at 5.0 mg/kg, 1 at 2.5 mg/kg and 2 in
placebo; no deaths were deemed related to the study
drug1.
About SEG101 (crizanlizumab)
SEG101 (crizanlizumab, formerly SelG1) is a humanized
anti-P-selectin monoclonal antibody that binds a molecule called
P-selectin on the surface of endothelial cells and platelets in the
blood vessels, causing a blockade of P-selectin1,5.
P-selectin drives the vaso-occlusive process1,6.
Vaso-occlusive crises, also known as SCPC, occur episodically
when sickle-shaped red blood cells block blood flow through blood
vessels7. The therapeutic blockade of P-selectin can
prevent painful vaso-occlusion in small blood vessels and maintain
blood flow1,7.
Disclaimer
The foregoing release contains forward-looking statements that
can be identified by words such as "potential," "potentially,"
"may," or similar terms, or by express or implied discussions
regarding potential marketing approvals for SEG101, or regarding
potential future revenues from SEG101. You should not place undue
reliance on these statements. Such forward-looking statements are
based on the current beliefs and expectations of management
regarding future events, and are subject to significant known and
unknown risks and uncertainties. Should one or more of these risks
or uncertainties materialize, or should underlying assumptions
prove incorrect, actual results may vary materially from those set
forth in the forward-looking statements. There can be no guarantee
that SEG101 will be submitted or approved for sale in any market,
or at any particular time. Nor can there be any guarantee that
SEG101 will be commercially successful in the future. In
particular, management's expectations regarding SEG101 could be
affected by, among other things, the uncertainties inherent in
research and development, including unexpected clinical trial
results and additional analysis of existing clinical data;
unexpected regulatory actions or delays or government regulation
generally; the company's ability to obtain or maintain proprietary
intellectual property protection; general economic and industry
conditions; competition in general; global trends toward health
care cost containment, including ongoing pricing pressures;
unexpected manufacturing, safety or quality issues, and other risks
and factors referred to in Novartis AG's current Form 20-F on file
with the US Securities and Exchange Commission. Novartis is
providing the information in this press release as of this date and
does not undertake any obligation to update any forward-looking
statements contained in this press release as a result of new
information, future events or otherwise.
About Novartis
Novartis Pharmaceuticals Corporation offers a broad range of
medicines for cancer, cardiovascular disease, endocrine disease,
inflammatory disease, infectious disease, neurological disease,
organ transplantation, psychiatric disease, respiratory disease and
skin conditions.
Located in East Hanover, NJ
Novartis Pharmaceuticals Corporation is an affiliate of Novartis
AG, which provides innovative healthcare solutions that address the
evolving needs of patients and societies. Headquartered in
Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative
medicines, eye care and cost-saving generic pharmaceuticals.
Novartis is the only global company with leading positions in these
areas. In 2015, the Group achieved net sales of USD 49.4 billion, while R&D throughout the
Group amounted to approximately USD 8.9
billion (USD 8.7 billion
excluding impairment and amortization charges). Novartis Group
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http://www.novartis.com.
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References
1. Ataga KI, et al. SUSTAIN: A Multicenter,
Randomized, Placebo-Controlled, Double-Blind, 12-Month Study to
Assess Safety and Efficacy of SelG1 with or without Hydroxyurea
Therapy in Sickle Cell Disease Patients with Sickle Cell-Related
Pain Crises. Abstract #1. 2016 58th American Society of
Hematology (ASH) Annual Meeting, San
Diego, California.
2. Segal JB, Strouse JJ, et al. Evidence
Reports/Technology Assessments, No. 165. Rockville, MD: Agency for Healthcare
Research and Quality (US); 2008 Feb.
3. Zumberg MS, Reddy S, et al. Hydroxyurea
therapy for sickle cell disease in community-based practices: a
survey of Florida and North Carolina hematologists/oncologists. Am J
Hematol. 2005 Jun;79(2):107–113.
4. Miller ST, Kim HY, et al. for Sickle Cell
Disease Clinical Research Network (SCDCRN). Inpatient management of
sickle cell pain: A 'snapshot' of current practice. Am J Hematol.
2012 Mar;87(3):333–336.
5. Novartis Pharmaceuticals Corporation. Data
on file. 2016.
6. Manwani D. Frenette PS. Vaso-occlusion in
sickle cell disease: pathophysiology and novel targeted therapies.
Blood. 2013; 122(24):3892-3898.
7. Quinn CT. Anti-adhesive therapy for sickle
cell disease. The Hematologist. 2014;11(6):15.
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