PH284 nasal spray demonstrated improvements to
subjective feelings of hunger in cancer patients
PH284 is the fifth pherine product candidate in
Vistagen’s neuroscience pipeline with a positive efficacy
signal
Vistagen (Nasdaq: VTGN), a late clinical-stage company dedicated
to pioneering neuroscience based on nose-to-brain neurocircuitry,
today announced positive results from an exploratory Phase 2A study
of PH284 in cancer cachexia. PH284 is an investigational pherine
nasal spray differentiated from all current treatments for the loss
of appetite associated with chronic disorders, such as cancer. In
the study, PH284 demonstrated higher mean subjective feeling of
hunger as compared to placebo and appeared safe and well-tolerated
with an adverse event profile similar to placebo in a population
compromised by terminal cancer.
“We are highly encouraged by the potential of PH284 to improve
the quality of life for those challenged by the debilitating
impacts of cancer cachexia,” stated Shawn Singh, President and
Chief Executive Officer of Vistagen. “Loss of appetite from cancer
and other illnesses not only negatively impacts overall health and
quality of life, but can also reduce the effectiveness of critical
therapies, such as chemotherapy in cancer patients. PH284 is our
fifth novel investigational pherine, each supported by positive
Phase 2 or later clinical data and placebo-like tolerability,
underscoring the breadth, diversity and potential of our
neuroscience pipeline to address multiple significant unmet
needs.”
The previously unreported double-blind, placebo-controlled
exploratory Phase 2A study was designed to evaluate the efficacy,
safety, and tolerability of intranasal administration of PH284 in
female patients diagnosed with cachexia (induced by chronic loss of
appetite) due to terminal cancer (n=40). PH284 nasal spray (0.4
µg/50 µL) was administered intranasally, one spray in each nostril
(total daily dose = 3.2µg), four times daily before meals
(breakfast, mid-morning snack, lunch, and dinner). From Day 1
through Day 4, all subjects were administered placebo 30 minutes
prior to each meal. Beginning on Day 5 through Day 11 subjects were
randomized in a 1:1 fashion to receive either PH284 or placebo.
Efficacy
Patients measured Subjective Feeling of Hunger (SFH) ten minutes
before each meal. PH284, as compared to placebo, induced a
cumulative effect on mean SFH scores, with scores increasing from
breakfast to lunch and lunch to dinner throughout the treatment
period. Specifically, prior to dinner on Day 7 of treatment, PH284
subjects reported a 71% improvement in SFH versus baseline, while
placebo subjects reported a less than 1% improvement.
Safety and Tolerability
No unusual changes in body weight were observed in either the
PH284 or placebo groups, though on average, there was a small gain
in body weight for PH284 versus a small loss in placebo. PH284
demonstrated no serious adverse events, and adverse events reported
for the PH284 group were similar to those reported in the
placebo-treated group. All the adverse events reported were
attributed to the underlying medical condition (cancer) and were
not deemed to be related to the administration of PH284 or
placebo.
About Cachexia
Cachexia, also known as wasting syndrome, is a complex metabolic
syndrome that causes a gradual loss of muscle and body weight.
Cachexia is associated with chronic diseases like cancer, AIDS,
heart failure, chronic obstructive pulmonary disease (COPD),
anorexia nervosa, multiple sclerosis, tuberculosis, and anemias.
The current definition of cancer cachexia is a loss of 5% or more
of body weight over the preceding six months, accompanied by any of
a handful of other symptoms, including fatigue and reduced
strength. According to the National Cancer Institute, cachexia is
estimated to occur in up to 80% of people with advanced cancer,
depending on the type of cancer and how well they respond to cancer
treatment. Cachexia is thought to directly cause up to 30% of
cancer deaths, often because of heart or respiratory failure
related to muscle loss. Maintaining nutritional support and
alleviating cachexia has the potential to improve the underlying
condition of cancer. Currently, there are no effective medical
interventions or approved drugs proven to alleviate cachexia.
This previously unreported Phase 2A exploratory study of PH284
was sponsored by Pherin Pharmaceuticals (Pherin), now a wholly
owned subsidiary of Vistagen, and conducted at the National
Institute of Oncology (INCAN) and National Institute of Nutrition
(INNSZ) in Mexico City, Mexico, in 2005. Vistagen gained access to
the results of this study in connection with its acquisition of
Pherin in February 2023. Hector Burges, MD, former Director,
Institute of Nutrition; Marcos Cano Guardiana, MD, Associate
Professor, National Institute of Oncology, Mexico City; and Ricardo
Plancarte Sanchez, MD, Head of the Pain Clinic, Institute of
Oncology, Mexico City, served as the Principal Investigators of the
study.
About PH284
PH284 is an investigational neuroactive pherine nasal spray with
a novel, rapid-onset potential mechanism of action (MOA) that is
fundamentally differentiated from the MOA of all current treatments
for the loss of appetite associated with chronic disorders, such as
cancer or heart disease. PH284 is thought to act by regulating
olfactory to mediobasal-hypothalamus neural circuits involved in
appetite control. PH284 has demonstrated an excellent safety
profile in all clinical trials completed to date. Vistagen is
currently evaluating the potential path forward for PH284,
including an assessment of completed studies and studies we believe
are necessary to support a U.S. Investigational New Drug
application for potential further Phase 2 clinical development of
PH284 for the treatment of cachexia.
About Vistagen
Headquartered in South San Francisco, CA, Vistagen (Nasdaq:
VTGN) is a late clinical-stage company leveraging its pioneering
neuroscience and deep understanding of nose-to-brain neurocircuitry
to develop and commercialize a broad and diverse pipeline of
intranasal product candidates called pherines. Each pherine product
candidate in Vistagen’s neuroscience pipeline is designed to
rapidly activate olfactory system and brain neurocircuitry to
achieve desired therapeutic benefits and differentiated safety
without requiring systemic absorption or binding to neurons in the
brain. Vistagen’s neuroscience pipeline also includes an oral
prodrug, AV-101, with potential to impact certain neurological
conditions involving the NMDA receptor. Vistagen is passionate
about developing transformative treatment options to improve the
lives of individuals underserved by the current standard of care
for multiple highly prevalent disorders, including social anxiety
disorder, major depressive disorder, and vasomotor symptoms (hot
flashes) associated with menopause. Connect at
www.Vistagen.com.
Forward-looking Statements
This press release contains certain forward-looking statements
within the meaning of the federal securities laws. These
forward-looking statements involve known and unknown risks that are
difficult to predict and include all matters that are not
historical facts. In some cases, you can identify forward-looking
statements by the use of words such as “may,” “could,” “expect,”
“project,” “outlook,” “strategy,” “intend,” “plan,” “seek,”
“anticipate,” “believe,” “estimate,” “predict,” “potential,”
“strive,” “goal,” “continue,” “likely,” “will,” “would” and
variations of these terms and similar expressions, or the negative
of these terms or similar expressions. Such forward-looking
statements are necessarily based upon estimates and assumptions
that, while considered reasonable by Vistagen and its management,
are inherently uncertain. As with all pharmaceutical products,
there are substantial risks and uncertainties in the process of
development and commercialization and actual timelines, results or
development may differ materially from those projected or implied
in these forward-looking statements. There can be no guarantee that
PH284, or any of Vistagen’s product candidates, will successfully
replicate past clinical trials, complete ongoing or future clinical
trials within the timeframe estimated by Vistagen or at all,
receive regulatory approval or be commercially successful. Other
factors that may cause such a difference include, without
limitation, risks and uncertainties relating to delays in
launching, conducting and/or completing ongoing and planned
clinical trials; the availability and scope of applicable patents;
fluctuating costs of materials and other resources and services
required to conduct Vistagen’s ongoing and/or planned clinical and
nonclinical trials; market conditions; the impact of general
economic, industry or political conditions in the United States or
internationally; and other technical and unexpected hurdles in the
development, manufacture and commercialization of Vistagen’s
product candidates. These risks are more fully discussed in the
section entitled "Risk Factors" in Vistagen’s most recent Annual
Report on Form 10-K for the fiscal year ended March 31, 2024 and
Quarterly Report on Form 10-Q for the period ended September 30,
2024, as well as discussions of potential risks, uncertainties, and
other important factors in our other filings with the U.S.
Securities and Exchange Commission (SEC). Vistagen’s SEC filings
are available on the SEC’s website at www.sec.gov. Additionally,
you should not place undue reliance on these forward-looking
statements in the future, because they apply only as of the date of
this press release and should not be relied upon as representing
Vistagen’s views as of any subsequent date. Vistagen explicitly
disclaims any obligation to update any forward-looking statements,
other than as may be required by law. If Vistagen does update one
or more forward-looking statements, no inference should be made
that Vistagen will make additional updates with respect to those or
other forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20250114229501/en/
Investors: Mark A. McPartland Vistagen Therapeutics
markmcp@vistagen.com
Media: Michelle Wellington Vistagen Therapeutics
mwellington@vistagen.com
Vistagen Therapeutics (NASDAQ:VTGN)
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