Acer Therapeutics Announces Initiation of Two Investigator-Sponsored Trials of ACER-801 (Osanetant) in Men with Adenocarcinoma of the Prostate
05 Enero 2023 - 7:30AM
Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company
focused on the acquisition, development and commercialization of
therapies for serious rare and life-threatening diseases with
significant unmet medical needs, today announced the initiation of
two Phase 2, single-arm investigator-sponsored trials evaluating
ACER-801 (osanetant) in men with adenocarcinoma of the prostate.
The POSH-MAP (Pilot of Osanetant for Severity of Hot Flashes in Men
with Adenocarcinoma of the Prostate) and PORT-MAP (Pilot of
Osanetant to Reduce Testosterone in Men with Adenocarcinoma of the
Prostate) trials are being sponsored and conducted by The
University of Kansas Cancer Center in partnership with Acer.
POSH-MAP Trial The POSH-MAP trial will evaluate the ability of
ACER-801 to reduce hot flash frequency and severity and improve
quality of life measures in men with prostate cancer following 28
days of therapy. Approximately 10 participants will receive 200mg
of osanetant twice daily. Following the completion of treatment on
day 28 participants will re-test hormone levels and report final
patient outcome measures. More information on this trial can be
found here.
“Prostate cancer’s responsiveness to hormone-based treatments
that decrease testosterone levels such as leuprolide or other forms
of androgen deprivation therapy (ADT) have established them as the
standard of care for treatment of prostate cancer,” said Elizabeth
Wulff-Burchfield, MD, Principal Investigator of the POSH-MAP trial,
Divisions of Medical Oncology and Palliative Medicine, Department
of Medicine, The University of Kansas Health System. “However, for
men on ADT, this causes a secondary decline in estrogen that
results in dysfunctional thermoregulation and development of
vasomotor symptoms (VMS) which can affect quality of life and lead
to treatment non-adherence.1 With clinical data showing the
potential of neurokinin 3 receptor (NK3R) antagonism to reduce
menopausal related VMS in women,2 we look forward to evaluating the
ability of ACER-801 to help mediate ADT-related VMS in men with
prostate cancer.”
PORT-MAP TrialThe second trial, PORT-MAP, will evaluate the
ability of ACER-801 to suppress testosterone production in men with
prostate cancer within 28 days prior to a planned prostatectomy.
Approximately 10 participants will receive 200mg of osanetant twice
daily for 28 days, followed by a one week wash out period.
Following the one week wash out period, patients will undergo a
prostatectomy between days 35-39. The overall effect of osanetant
on testosterone levels and the proportion of men achieving castrate
levels of testosterone (<50ng/ml) will be assessed, with hormone
level assessment occurring on days 2, 3, 14, 28 and day 77. More
information on this trial can be found here.
“Early studies in healthy male volunteers treated with various
NK3R antagonists have shown an inhibitory effect on the levels of
testosterone,” said William Parker, MD, Principal Investigator,
Division of Urologic Oncology, Department of Urology, The
University of Kansas Health System. “However, the ability of NK3R
antagonists to reduce testosterone to castrate levels in prostate
cancer patients has not been evaluated to date. Based on these
data, we look forward to evaluating the potential of ACER-801 and
its ability to reduce testosterone in men with prostate
cancer.”
“We are pleased to partner with The University of Kansas Cancer
Center to evaluate ACER-801 in men with prostate cancer currently
receiving ADT treatment in these investigator-sponsored trials,”
said Adrian Quartel, MD, FFPM, Chief Medical Officer of Acer. “With
the recent expansion of our ACER-801 (osanetant) program into
stress-related trauma disorders, including PTSD, and now men with
prostate cancer, we look forward to the ongoing evaluation of
ACER-801 in multiple indications and reporting topline results from
our ongoing Phase 2a trial for the treatment of moderate to severe
VMS in post-menopausal women in Q1 2023.”
Rationale for ACER-801 (osanetant) NK3R Antagonist
Evaluation in Prostate Cancer Prostate cancer
is a hormonally driven cancer, and the management of this disease
for many men is through suppression of testosterone production –
called androgen deprivation therapy (ADT). Currently, most men on
ADT are treated with medications that suppress hormone production
which can cause dysfunctional thermoregulation and development of
vasomotor symptoms (VMS), also known as hot flashes. Up to 75% of
men on ADT experience VMS, resulting in high rates of distress and
ADT treatment noncompliance, with approximately 20% of men with
high-risk prostate cancer prematurely discontinuing ADT.3 Early
pharmacokinetic studies in men and women with various NK3R
antagonists have shown an inhibitory effect on the levels of
luteinizing hormone and testosterone. However, the degree of effect
relative to a therapeutic goal of castrate levels of testosterone
(≤ 50ng/mL) remains unexplored.1,2 A non-hormonal treatment to
lower testosterone levels and manage induced VMS is needed as
estrogen is contraindicated for the management of VMS in patients
with hormone-positive tumors, including breast and prostate
tumors.
ACER-801 is an investigational product candidate which has not
been approved by FDA or any other regulatory authority. There is no
guarantee that this product candidate will receive regulatory
authority approval in any territory or become commercially
available for any indications.
About Acer Therapeutics
Inc.Acer is a pharmaceutical company
focused on the acquisition, development and commercialization of
therapies for serious rare and life-threatening diseases with
significant unmet medical needs. In the U.S., OLPRUVA™ (sodium
phenylbutyrate) is approved for the treatment of urea cycle
disorders (UCDs) involving deficiencies of carbamylphosphate
synthetase (CPS), ornithine transcarbamylase (OTC), or
argininosuccinic acid synthetase (AS). Acer is also advancing a
pipeline of investigational product candidates for rare and
life-threatening diseases, including: OLPRUVA™ (sodium
phenylbutyrate) for treatment of various disorders, including Maple
Syrup Urine Disease (MSUD); ACER-801 (osanetant) for treatment of
induced Vasomotor Symptoms (iVMS), Post-traumatic Stress Disorder
(PTSD) and prostate cancer; EDSIVO™ (celiprolol) for treatment of
vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed
type III collagen (COL3A1) mutation; and ACER-2820 (emetine), a
host-directed therapy against a variety of viruses, including
cytomegalovirus, Zika, dengue, Ebola and COVID-19. For more
information, visit www.acertx.com.
References
- Challapalli, Amarnath, et al. “Evaluating the Prevalence and
Predictive Factors of Vasomotor and Psychological Symptoms in
Prostate Cancer Patients Receiving Hormonal Therapy: Results from a
Single Institution Experience.” Clinical and Translational
Radiation Oncology, Elsevier, 21 Mar. 2018
- Prague J. et al. Neurokinin 3 receptor antagonism rapidly
improves vasomotor symptoms with sustained duration of action.
Menopause. 2018 Aug; 25(8): 862–869.
- Trinity Partners 2020
Acer Forward-Looking StatementsThis press
release contains “forward-looking statements” that involve
substantial risks and uncertainties for purposes of the safe harbor
provided by the Private Securities Litigation Reform Act of 1995.
All statements, other than statements of historical facts, included
in this press release are forward-looking statements. Examples of
such statements include, but are not limited to, statements about
the role we believe ACER-801 could play in mediating ADT-related
VMS in men with prostate cancer and reducing testosterone levels in
men with prostate cancer, the planned clinical evaluation of
ACER-801 for such indications, plans with respect to the POSH-MAP
trial and PORT-MAP trial, including enrollment, timing, outcome and
participants, the continued development of ACER-801 for multiple
indications, and our plans, including timing, to report topline
results from our ongoing Phase 2a trial for the treatment of
moderate to severe VMS in post-menopausal women. Our pipeline
products (including ACER-801) are under investigation and their
safety and efficacy have not been established and there is no
guarantee that any of our investigational products in development
will receive health authority approval or become commercially
available for the uses being investigated. We may not actually
achieve the plans, carry out the intentions or meet the
expectations or projections disclosed in the forward-looking
statements and you should not place undue reliance on these
forward-looking statements. Such statements are based on
management’s current expectations and involve risks and
uncertainties. Actual results and performance could differ
materially from those projected in the forward-looking statements
as a result of many factors, including, without limitation, the
availability of financing to fund our pipeline product development
programs and general corporate operations as well as risks related
to drug development and the regulatory approval process, including
the timing and requirements of regulatory actions. We disclaim any
intent or obligation to update these forward-looking statements to
reflect events or circumstances that exist after the date on which
they were made. You should review additional disclosures we make in
our filings with the Securities and Exchange Commission, including
our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
You may access these documents for no charge
at http://www.sec.gov.
Acer ContactsCorporate contact:Jim DeNikeAcer
Therapeutics Inc.jdenike@acertx.com+1-844-902-6100
Investor contact:Nick ColangeloGilmartin
Groupnick@gilmartinIR.com+1-332-895-3226
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