MONTREAL, July 24, 2017 /PRNewswire/
-- Theratechnologies Inc. (Theratechnologies) (TSX: TH)
announced today that results on HIV susceptibility to ibalizumab
from the Phase IIb trial, TMB-202, along with new findings for
EGRIFTA® (tesamorelin for injection), are being
presented during poster sessions at the 9th IAS
Conference on HIV Science (IAS 2017) in Paris, France.
Ibalizumab
The Phase II data for ibalizumab, a long-acting monoclonal
antibody, show no significant difference in susceptibility
(measured by maximum percent inhibition or ICHALFMAX
Fold Change) in patient HIV isolates that were either sensitive or
resistant to other antiretroviral agents, including nucleoside
reverse transcriptase inhibitors, non-nucleoside reverse
transcriptase inhibitors, protease inhibitors, integrase strand
transfer inhibitors, enfuvirtide and maraviroc.
"HIV drug resistance is a key topic at the IAS conference this
year, and these findings are particularly important as they suggest
that ibalizumab is equally active against HIV whether it is
resistant or responsive to approved antiretroviral agents," said
Steve Weinheimer, Vice President,
Biological Sciences at TaiMed Biologics USA. "On the heels of the BLA acceptance for
priority review, these data provide additional support for
ibalizumab as a potential tool for the treatment of multidrug
resistant HIV-1," added Mr. Weinheimer.
EGRIFTA®
In a retrospective analysis of datasets from two, multicenter,
randomized placebo-controlled trials of EGRIFTA®
among HIV-infected adults with lipodystrophy, fat in trunk muscles
decreased and trunk muscle area increased over 26 weeks in patients
with excess visceral adipose tissue (VAT, abdominal fat) who had
shown a clinical response to EGRIFTA® (VAT
decrease of 8 percent or more). These results were seen across a
number of trunk muscle groups and were independent of the change in
amount of VAT for many of the measures.
"This is the first study to evaluate changes in trunk muscle fat
(both abdominal and spine musculature) in HIV patients who have
responded to tesamorelin," said Kristine
Erlandson, MD, Assistant Professor of Medicine, Divisions of
Infectious Disease and Geriatric Medicine, University of Colorado. "We are pleased to continue
to uncover new information on the potential effects of tesamorelin
in HIV patients with excess abdominal fat," added Dr.
Erlandson.
EGRIFTA® is not indicated for trunk
muscle fat decrease.
About ibalizumab
Ibalizumab is an investigational humanized monoclonal antibody
being developed for the treatment of multidrug resistant HIV-1
infection. Unlike other antiretroviral agents, ibalizumab binds
primarily to the second extracellular domain of the CD4+ T cell
receptor, away from major histocompatibility complex II molecule
binding sites. It potentially prevents HIV from infecting CD4+
immune cells while preserving normal immunological function.
Ibalizumab is active against HIV-1 resistant to all approved
antiretroviral agents.
Ibalizumab is currently under review by the FDA following the
acceptance of a Biologics License Application on June 30, 2017.
INDICATION AND IMPORTANT RISK INFORMATION
FOR EGRIFTA®
Indication
EGRIFTA® is indicated for the reduction
of excess abdominal fat in HIV-infected patients with
lipodystrophy.
Limitations of Use:
- The impact and safety of EGRIFTA® on
cardiovascular health have not been studied.
- EGRIFTA® is not indicated for weight loss
management.
- It is not known whether taking EGRIFTA® helps
improve compliance with anti-retroviral medications.
Contraindications:
Do not use EGRIFTA® if you:
- Have pituitary gland tumor, pituitary gland surgery or other
problems related to your pituitary gland.
- Have active cancer, either newly diagnosed or recurrent, or are
receiving treatment for cancer.
- Are allergic to tesamorelin or any of the ingredients in
EGRIFTA®.
- Are pregnant or become pregnant. If you become pregnant, stop
using EGRIFTA® and talk with your healthcare
provider.
Warnings and Precautions
- Neoplasms: EGRIFTA® therapy should be
initiated after careful evaluation of the potential benefit of
treatment in patients with a history of non-malignant neoplasms or
treated and stable malignancies.
- Elevated IGF-1: IGF-1 levels should be monitored closely
during EGRIFTA® therapy. Careful medical
consideration should be given to discontinuing
EGRIFTA® in patients with persistent elevations
of IGF-1 levels (eg, >3 SDS).
- Fluid Retention: Fluid retention, manifesting as
increased tissue turgor and musculoskeletal discomfort, may occur
during EGRIFTA® therapy.
- Glucose Intolerance: EGRIFTA®
treatment may result in glucose intolerance. Glucose status should
be carefully evaluated prior to initiating
EGRIFTA® treatment and monitored periodically for
changes in glucose metabolism.
- Hypersensitivity Reactions: Hypersensitivity reactions
may occur in patients treated with EGRIFTA®. In
cases of suspected hypersensitivity reactions, patients should be
advised to seek prompt medical attention and treatment with
EGRIFTA® should be discontinued immediately
- Injection Site Reactions: EGRIFTA®
treatment may cause injection site reactions, including injection
site erythema, pruritus, pain, irritation, and bruising.
- Acute Critical Illness: EGRIFTA® has
not been studied in patients with acute critical illness. Increased
mortality in patients with acute critical illness due to
complications following open heart surgery, abdominal surgery or
multiple accidental trauma, or those with acute respiratory failure
has been reported after treatment with pharmacologic amounts of
growth hormone. Since EGRIFTA® stimulates growth
hormone production, careful consideration should be given to
discontinuing EGRIFTA® in critically ill
patients.
Drug Interactions
- Cytochrome P450-Metabolized Drugs:
EGRIFTA® had no significant impact on the
pharmacokinetic profiles of simvastatin in healthy subjects;
however, careful monitoring is advisable when
EGRIFTA® is administered in combination with
other drugs known to be metabolized by CYP450 liver enzymes.
- Growth hormone is known to inhibit 11β-hydroxysteroid
dehydrogenase type 1 or 11βHSD-1, a microsomal enzyme required for
conversion of cortisone to its active metabolite, cortisol, in
hepatic and adipose tissue. Because tesamorelin stimulates growth
hormone production, patients receiving glucocorticoid replacement
for previously diagnosed hypoadrenalism may require an increase in
maintenance or stress doses following initiation of
EGRIFTA®, particularly in patients treated with
cortisone acetate and prednisone because conversion of these drugs
to their biologically active metabolites is dependent on the
activity of 11βHSD-1.
Immunogenicity
- Anti-tesamorelin IgG antibodies were detected in approximately
half of patients treated with EGRIFTA® and
generally disappeared over time after discontinuation of treatment.
Antibodies did not appear to impact the efficacy of
EGRIFTA®
Use in Specific Populations.
- Nursing Mothers: Because of both the potential for HIV-1
infection transmission and serious adverse reactions in nursing
infants, mothers receiving EGRIFTA® should be
instructed not to human breast-feed
- Pediatric Use: Safety and effectiveness in pediatric
patients have not been established.
- Geriatric Use: There is no information on the use of
EGRIFTA® in patients greater than 65 years of age
with HIV and lipodystrophy
- Renal and Hepatic Impairment: Safety, efficacy, and
pharmacokinetics of EGRIFTA® in patients with
renal or hepatic impairment have not been established
- Pregnancy: EGRIFTA® is contraindicated
in pregnant women. During pregnancy, visceral adipose tissue
increases due to normal metabolic and hormonal changes. Modifying
this physiologic change of pregnancy with
EGRIFTA® offers no known benefit and could result
in fetal harm.
Adverse Reactions
In clinical trials, the most common EGRIFTA®
adverse reactions occurring in >5% of patients during the
26-week main phase of the combined studies included
hypersensitivity reactions, reactions due to the effect of GH
including arthralgia, extremity pain, peripheral edema, and
myalgia, and injection site reactions including injection site
erythema and pruritis.
For complete disclosure of EGRIFTA® product
information, please read the Full Prescribing Information,
Patient Information, and Patient Instructions for Use.
For more information about EGRIFTA®, contact
the EGRIFTA ASSIST™ toll-free at 1-844-347-EGRIFTA or
1-844-347-4382. To report suspected adverse reactions, contact the
EGRIFTA ASSIST™ toll-free or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
About Theratechnologies
Theratechnologies (TSX: TH) is a specialty pharmaceutical
company addressing unmet medical needs to promote healthy ageing
and an improved quality of life among HIV patients. Further
information about Theratechnologies is available on the Company's
website at www.theratech.com and on SEDAR at www.sedar.com.
Forward-Looking Information
This press release contains statements that are considered
forward-looking information ("FLI") within the meaning of
securities laws that are based on our management's belief and
assumptions and on information currently available to our
management. You can identify forward-looking statements by terms
such as "may", "will", "should", "could", "would", "outlook",
"believe", "plan", "envisage", "anticipate", "expect" and
"estimate" or the negatives of these terms, or variations of them.
The forward-looking statements contained in this press release
include, but are not limited to, the approval of ibalizumab in
the United States for the
treatment of MDR HIV-1 infected patients, the effect of ibalizumab
to treat HIV and, more particularly, the treatment of multidrug
resistant HIV-1, and the growth of Theratechnologies based on such
approval.
Forward-looking statements are based upon a number of
assumptions and are subject to a number of risks and uncertainties,
many of which are beyond Theratechnologies' control that could
cause actual results to differ materially from those that are
disclosed in or implied by such forward-looking information. These
assumptions include but are not limited to, the following:
ibalizumab will be approved by the FDA for the treatment of MDR
HIV-1 infected patients and, if approved, Theratechnologies will
have set-up on time the necessary infrastructure to launch and
commercialize ibalizumab in the United
States, and ibalizumab will be well received by the
marketplace. These risks and uncertainties include, but are not
limited to, the risk that the FDA does not approve ibalizumab as a
treatment for MDR HIV-1 infection and, if approved, that the FDA
imposes a significant limitation on its use resulting in a smaller
patient population who could benefit from ibalizumab, that
additional clinical trials are requested to be conducted prior to
approving, or post-approval of, ibalizumab, that sales of
EGRIFTA® decrease or that untoward side effects
become known leading to a recall or the withdrawal of
EGRIFTA® from the market.
We refer potential investors to the "Risk Factors" section of
our Annual Information Form (AIF) dated February 7, 2017 for additional risks and
uncertainties about Theratechnologies. The AIF is available on the
Company's website at www.theratech.com and on SEDAR at
www.sedar.com. The reader is cautioned to consider these and other
risks and uncertainties carefully and not to put undue reliance on
forward-looking statements. Forward-looking statements reflect
current expectations regarding future events and speak only as of
the date of this press release and represent our expectations as of
that date. We undertake no obligation to update or revise the
information contained in this press release, whether as a result of
new information, future events or circumstances or otherwise,
except as may be required by applicable law.
Contact:
Philippe Dubuc
Senior Vice President and Chief Financial Officer
Tel.: (514) 336-7800, ext. 297
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SOURCE Theratechnologies Inc.