TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the
details of an upcoming oral presentation, highlighting data from
the ULTIMATE I & II Phase 3 trials evaluating
BRIUMVI
® (ublituximab-xiiy) in patients with
relapsing forms of multiple sclerosis (RMS), to be presented at the
upcoming Consortium of Multiple Sclerosis Centers (CMSC) annual
meeting, being held May 31 - June 4, 2023, in Aurora, Colorado. The
abstract is now available online and can be accessed on the
International Journal of MS Care (IJMSC) website at www.ijmsc.org,
or by following this direct
link: https://doi.org/10.7224/1537-2073-25.s1.1. Details of
the presentation are included below.
Oral
Presentation: Ublituximab Is Associated
with Significant Improvement in Fatigue: Results from Ultimate I
and II
- Presentation Date/Time: Thursday, June 1, 2023/ 3:20 – 3:40 PM
MT
- Session: Disease Modifying Therapies – Summit 6-7
- Presentation ID: DMT02
- Lead Author: Enrique Alvarez, MD, University of Colorado,
Aurora, CO
Following the presentation, the data will be
available on the Publications page, located within the Pipeline
section, of the Company’s website at
www.tgtherapeutics.com/publications.cfm.
ABOUT THE ULTIMATE I & II PHASE 3
TRIALSULTIMATE I & II are two randomized,
double-blind, double-dummy, parallel group, active
comparator-controlled clinical trials of identical design, in
patients with RMS treated for 96 weeks. Patients were randomized to
receive either BRIUMVI, given as an IV infusion of 150 mg
administered in four hours, 450 mg two weeks after the first
infusion administered in one hour, and 450 mg every 24 weeks
administered in one hour, with oral placebo administered daily; or
teriflunomide, the active comparator, given orally as a 14 mg daily
dose with IV placebo administered on the same schedule as BRIUMVI.
Both studies enrolled patients who had experienced at least one
relapse in the previous year, two relapses in the previous two
years, or had the presence of a T1 gadolinium (Gd)-enhancing lesion
in the previous year. Patients were also required to have an
Expanded Disability Status Scale (EDSS) score from 0 to 5.5 at
baseline. The ULTIMATE I & II trials enrolled a total of 1,094
patients with RMS across 10 countries. These trials were led by
Lawrence Steinman, MD, Zimmermann Professor of Neurology and
Neurological Sciences, Pediatrics and Genetics, at Stanford
University. Additional information on these clinical trials can be
found at www.clinicaltrials.gov (NCT03277261; NCT03277248).
ABOUT BRIUMVI® (ublituximab-xiiy) 150 mg/6
mL Injection for IVBRIUMVI is a novel monoclonal antibody
that targets a unique epitope on CD20-expressing B-cells. Targeting
CD20 using monoclonal antibodies has proven to be an important
therapeutic approach for the management of autoimmune disorders,
such as RMS. BRIUMVI is uniquely designed to lack certain sugar
molecules normally expressed on the antibody. Removal of these
sugar molecules, a process called glycoengineering, allows for
efficient B-cell depletion at low doses.
BRIUMVI is indicated for the treatment of adults
with relapsing forms of multiple sclerosis (RMS), to include
clinically isolated syndrome, relapsing-remitting disease, and
active secondary progressive disease.
A list of authorized specialty distributors can be
found at www.briumvi.com.
IMPORTANT SAFETY
INFORMATIONContraindications: BRIUMVI is
contraindicated in patients with:
- Active HBV infection
- A history of life-threatening infusion reaction to BRIUMVI
WARNINGS AND PRECAUTIONS
Infusion Reactions: BRIUMVI can
cause infusion reactions, which can include pyrexia, chills,
headache, influenza-like illness, tachycardia, nausea, throat
irritation, erythema, and an anaphylactic reaction. In MS clinical
trials, the incidence of infusion reactions in BRIUMVI-treated
patients who received infusion reaction-limiting premedication
prior to each infusion was 48%, with the highest incidence within
24 hours of the first infusion. 0.6% of BRIUMVI-treated patients
experienced infusion reactions that were serious, some requiring
hospitalization.
Observe treated patients for infusion reactions
during the infusion and for at least one hour after the completion
of the first two infusions unless infusion reaction and/or
hypersensitivity has been observed in association with the current
or any prior infusion. Inform patients that infusion reactions can
occur up to 24 hours after the infusion. Administer the recommended
pre-medication to reduce the frequency and severity of infusion
reactions. If life-threatening, stop the infusion immediately,
permanently discontinue BRIUMVI, and administer appropriate
supportive treatment. Less severe infusion reactions may involve
temporarily stopping the infusion, reducing the infusion rate,
and/or administering symptomatic treatment.
Infections: Serious,
life-threatening or fatal, bacterial and viral infections have been
reported in BRIUMVI-treated patients. In MS clinical trials, the
overall rate of infections in BRIUMVI-treated patients was 56%
compared to 54% in teriflunomide-treated patients. The rate of
serious infections was 5% compared to 3% respectively. There were 3
infection-related deaths in BRIUMVI-treated patients. The most
common infections in BRIUMVI-treated patients included upper
respiratory tract infection (45%) and urinary tract infection
(10%). Delay BRIUMVI administration in patients with an active
infection until the infection is resolved.
Consider the potential for increased
immunosuppressive effects when initiating BRIUMVI after
immunosuppressive therapy or initiating an immunosuppressive
therapy after BRIUMVI.
Hepatitis B Virus (HBV)
Reactivation: HBV reactivation occurred in an MS patient
treated with BRIUMVI in clinical trials. Fulminant hepatitis,
hepatic failure, and death caused by HBV reactivation have occurred
in patients treated with anti-CD20 antibodies. Perform HBV
screening in all patients before initiation of treatment with
BRIUMVI. Do not start treatment with BRIUMVI in patients with
active HBV confirmed by positive results for HBsAg and anti-HB
tests.
For patients who are negative for
surface premedantigen [HBsAg] and positive for HB core
antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver
disease expert before starting and during treatment.
Progressive Multifocal Leukoencephalopathy
(PML): Although no cases of PML have occurred in
BRIUMVI-treated MS patients, JCV infection resulting in PML has
been observed in patients treated with other anti-CD20 antibodies
and other MS therapies.
If PML is suspected, withhold BRIUMVI and perform
an appropriate diagnostic evaluation. Typical symptoms associated
with PML are diverse, progress over days to weeks, and include
progressive weakness on one side of the body or clumsiness of
limbs, disturbance of vision, and changes in thinking, memory, and
orientation leading to confusion and personality changes.
MRI findings may be apparent before clinical signs
or symptoms; monitoring for signs consistent with PML may be
useful. Further investigate suspicious findings to allow for an
early diagnosis of PML, if present. Following discontinuation of
another MS medication associated with PML, lower PML-related
mortality and morbidity have been reported in patients who were
initially asymptomatic at diagnosis compared to patients who had
characteristic clinical signs and symptoms at diagnosis.
If PML is confirmed, treatment with BRIUMVI should
be discontinued.
Vaccinations: Administer all
immunizations according to immunization guidelines: for live or
live-attenuated vaccines at least 4 weeks and, whenever possible at
least 2 weeks prior to initiation of BRIUMVI for non-live vaccines.
BRIUMVI may interfere with the effectiveness of non-live vaccines.
The safety of immunization with live or live-attenuated vaccines
during or following administration of BRIUMVI has not been studied.
Vaccination with live virus vaccines is not recommended during
treatment and until B-cell repletion.
Vaccination of Infants Born to Mothers
Treated with BRIUMVI During Pregnancy: In infants of
mothers exposed to BRIUMVI during pregnancy, assess B-cell counts
prior to administration of live or live-attenuated vaccines as
measured by CD19+ B-cells. Depletion of B-cells in these infants
may increase the risks from live or live-attenuated vaccines.
Inactivated or non-live vaccines may be administered prior to
B-cell recovery. Assessment of vaccine immune responses, including
consultation with a qualified specialist, should be considered to
determine whether a protective immune response was mounted.
Fetal Risk: Based on data from
animal studies, BRIUMVI may cause fetal harm when administered to a
pregnant woman. Transient peripheral B-cell depletion and
lymphocytopenia have been reported in infants born to mothers
exposed to other anti-CD20 B-cell depleting antibodies during
pregnancy. A pregnancy test is recommended in females of
reproductive potential prior to each infusion. Advise females of
reproductive potential to use effective contraception during
BRIUMVI treatment and for 6 months after the last dose.
Reduction in Immunoglobulins: As
expected with any B-cell depleting therapy, decreased
immunoglobulin levels were observed. Decrease in immunoglobulin M
(IgM) was reported in 0.6% of BRIUMVI-treated patients compared to
none of the patients treated with teriflunomide in RMS clinical
trials. Monitor the levels of quantitative serum immunoglobulins
during treatment, especially in patients with opportunistic or
recurrent infections, and after discontinuation of therapy until
B-cell repletion. Consider discontinuing BRIUMVI therapy if a
patient with low immunoglobulins develops a serious opportunistic
infection or recurrent infections, or if prolonged
hypogammaglobulinemia requires treatment with intravenous
immunoglobulins.
Most Common Adverse Reactions: The
most common adverse reactions in RMS trials (incidence of at least
10%) were infusion reactions and upper respiratory tract
infections.
Physicians, pharmacists, or other healthcare
professionals with questions about BRIUMVI should
visit www.briumvi.com.
ABOUT BRIUMVI PATIENT SUPPORT
BRIUMVI Patient Support is a flexible program designed by TG
Therapeutics to support patients through their treatment
journey in a way that works best for them. More information about
the BRIUMVI Patient Support program can be accessed at
www.briumvipatientsupport.com.
ABOUT MULTIPLE SCLEROSISRelapsing
multiple sclerosis (RMS) is a chronic demyelinating disease of the
central nervous system (CNS) and includes people with
relapsing-remitting multiple sclerosis (RRMS) and people with
secondary progressive multiple sclerosis (SPMS) who continue to
experience relapses. RRMS is the most common form of multiple
sclerosis (MS) and is characterized by episodes of new or worsening
signs or symptoms (relapses) followed by periods of recovery. It is
estimated that nearly 1 million people are living with MS in the
United States and approximately 85% are initially diagnosed with
RRMS.1,2 The majority of people who are diagnosed with RRMS
will eventually transition to SPMS, in which they experience
steadily worsening disability over time. Worldwide, more than 2.3
million people have a diagnosis of MS.1
ABOUT TG THERAPEUTICSTG
Therapeutics is a fully integrated, commercial stage,
biopharmaceutical company focused on the acquisition, development
and commercialization of novel treatments for B-cell diseases. In
addition to a research pipeline including several investigational
medicines, TG has received approval from the U.S. FDA for BRIUMVI®
(ublituximab-xiiy), for the treatment of adult patients with
relapsing forms of multiple sclerosis, to include clinically
isolated syndrome, relapsing-remitting disease, and active
secondary progressive disease. For more information,
visit www.tgtherapeutics.com, and follow us on
Twitter @TGTherapeutics and on LinkedIn.
Cautionary StatementThis press
release contains forward-looking statements that involve a number
of risks and uncertainties. For those statements, we claim the
protection of the safe harbor for forward-looking statements
contained in the Private Securities Litigation Reform Act of
1995.
Any forward-looking statements in this press
release are based on management's current expectations and beliefs
and are subject to a number of risks, uncertainties and important
factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking
statements contained in this press release. In addition to the risk
factors identified from time to time in our reports filed with the
U.S. Securities and Exchange Commission (SEC), factors that could
cause our actual results to differ materially include the
below.
Such forward looking statements include but are not
limited to statements regarding the results of the ULTIMATE I &
II Phase 3 studies and BRIUMVI as a treatment for relapsing forms
of multiple sclerosis (RMS). Additional factors that could cause
our actual results to differ materially include the following: the
risk that the data from the ULTIMATE I & II trials that we
announce or publish may change, or the product profile of BRIUMVI
may be impacted, as more data or additional endpoints are analyzed;
the risk that data may emerge from future clinical studies or from
adverse event reporting that may affect the safety and tolerability
profile and commercial potential of BRIUMVI; the risk that any
individual patient’s clinical experience in the post-marketing
setting, or the aggregate patient experience in the post-marketing
setting, may differ from that demonstrated in controlled clinical
trials such as ULTIMATE I and II; the risk that BRIUMVI will not be
commercially successful; our ability to expand our commercial
infrastructure, and successfully market and sell BRIUMVI in RMS;
the Company’s reliance on third parties for manufacturing,
distribution and supply, and a range of other support functions for
our commercial and clinical products, including BRIUMVI, and the
ability of the Company and its manufacturers and suppliers to
produce and deliver BRIUMVI to meet the market demand for BRIUMVI;
the failure to obtain and maintain requisite regulatory approvals,
including the risk that the Company fails to satisfy post-approval
regulatory requirements; the uncertainties inherent in research and
development; and general political, economic and business
conditions, including the risk that the ongoing COVID-19 pandemic
could have on the safety profile of BRIUMVI and any of our other
drug candidates as well as any government control measures
associated with COVID-19 that could have an adverse impact on our
research and development plans or commercialization efforts.
Further discussion about these and other risks and uncertainties
can be found in our Annual Report on Form 10-K for the fiscal year
ended December 31, 2022 and in our other filings with
the U.S. Securities and Exchange Commission.
Any forward-looking statements set forth in this
press release speak only as of the date of this press release. We
do not undertake to update any of these forward-looking statements
to reflect events or circumstances that occur after the date
hereof. This press release and prior releases are available
at www.tgtherapeutics.com. The information found on our
website is not incorporated by reference into this press release
and is included for reference purposes only.
1. MS Prevalence. National
Multiple Sclerosis Society
website. https://www.nationalmssociety.org/About-the-Society/MS-Prevalence.
Accessed October 26, 2020. 2. Multiple
Sclerosis International Federation, 2013 via Datamonitor p.
236.
CONTACT:
Investor RelationsEmail:
ir@tgtxinc.comTelephone: 1.877.575.TGTX (8489), Option 4
Media Relations:Email:
media@tgtxinc.comTelephone: 1.877.575.TGTX (8489), Option 6
TG Therapeutics (NASDAQ:TGTX)
Gráfica de Acción Histórica
De Abr 2024 a May 2024
TG Therapeutics (NASDAQ:TGTX)
Gráfica de Acción Histórica
De May 2023 a May 2024