Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical
company, today announced that four abstracts have been accepted for
poster presentation at the upcoming 2019 American Society of
Clinical Oncology (ASCO) Genitourinary Cancers Symposium to be held
February 14-16, 2019, at the Moscone West Building in San
Francisco, California.
Three of the presentations will be for VERU-111, the Company’s
proprietary, next generation, first-in-class selective oral tubulin
inhibitor for the treatment of advanced prostate cancer which is
enrolling in a Phase1b/2 clinical study, and the fourth
presentation will be for zuclomiphene citrate (VERU-944), a
proprietary oral estrogen receptor agonist drug for the treatment
of hot flashes caused by androgen deprivation therapy (ADT) for men
with advanced prostate cancer which is currently enrolling in a
Phase 2 clinical trial.
Additional information on the meeting can be found on the ASCO
Genitourinary Cancers Symposium website: https://gucasym.org/. The
full abstracts will be made available online
via https://meetinglibrary.asco.org at 5:00 PM (EST) on
February 11, 2019.
Presentation details:
- Abstract Title: Design of Phase 1b/2
study of oral VERU-111, an α and β-tubulin inhibitor, for the
treatment of metastatic castration and androgen blocking agent
resistant prostate cancer.Presenter: Mark
Markowski, MD, PhD, Assistant Professor of Oncology, The Johns
Hopkins Sidney Kimmel Comprehensive Cancer CenterAbstract
Number: TPS330Board
Number: N6Session
Information: Poster Session A: Prostate
CancerDate/Time: February 14, 2019 – 11:30 AM
– 1:00 PM and 5:30 PM – 6:30 PM
- Abstract Title: VERU-111, a novel oral
inhibitor of α and β tubulin, inhibits tumor growth in
the human castration-resistant AR variant prostate cancer (PCa)
model 22Rv1Presenter: Mark Markowski, MD,
PhD, Assistant Professor of Oncology, The Johns Hopkins Sidney
Kimmel Comprehensive Cancer CenterAbstract
Number: 167Board
Number: G10Session
Information: Poster Session A: Prostate
CancerDate/Time: February 14, 2019 – 11:30 AM
– 1:00 PM and 5:30 PM – 6:30 PM
- Abstract Title: The oral α and β
tubulin inhibitor, VERU-111, demonstrates no neutropenia,
myelosuppression or abnormal liver function in doses being
evaluated for the treatment of metastatic castration resistant
prostate cancer in nonclinical toxicity
studies.Presenter: Robert H. Getzenberg, PhD,
Executive Associate Dean for Research and Professor of
Medicine, Patel College of Medicine, Nova Southeastern
UniversityAbstract Number: 299Board
Number: D7Session
Information: Poster Session B: Prostate Cancer;
Urothelial Carcinoma, Penile, Urethral, Testicular and Adrenal
CancersDate/Time: February 15, 2019 – 12:15
PM – 1:45 PM and 5:15 PM – 6:15 PM
- Abstract Title: A Phase 2, dose finding,
placebo-controlled, study of Zuclomiphene citrate to ameliorate the
frequency and severity of hot flashes caused by androgen
deprivation in men with advanced prostate
cancer.Presenter: Robert H. Getzenberg, PhD,
Executive Associate Dean for Research and Professor of
Medicine, Patel College of Medicine, Nova Southeastern
UniversityAbstract
Number: TPS338Board
Number: N14Session
Information: Poster Session A: Prostate
CancerDate/Time: February 14, 2019 – 11:30 AM
– 1:00 PM and 5:30 PM – 6:30 PM
About VERU-111VERU-111 is a novel, proprietary,
next generation, first-in-class oral selective antitubulin agent
that targets and disrupts alpha and beta tubulin subunits of
microtubules. In cancer cells, microtubules are critical for
transport of growth factor receptors, cellular proliferation, and
metastases. In preclinical effectiveness and toxicity studies,
orally administered VERU-111 demonstrated significant antitumor
activity against castration and novel androgen blocking agent
(abiraterone or enzalutamide) resistant human prostate cancers.
Furthermore, VERU-111 had significant antitumor effects against
cancers that overexpress multidrug resistant proteins, like
P-glycoprotein, a common mechanism by which cancer cells become
resistant to cancer drugs. At oral doses that had significant
antitumor effects, VERU-111 had a favorable safety profile as it
did not cause neutropenia or myelosuppression, common dose limiting
side effects of other classes of commercially available
antitubulins such as intravenous taxanes or intravenous vinca
alkaloids.
Veru is conducting an open label Phase1b/2 clinical trial
evaluating the safety and effectiveness of VERU-111 in men who have
metastatic castration resistant prostate cancer who have also
become resistant to novel androgen blocking agents like abiraterone
or enzalutamide. In addition to prostate cancer, VERU-111 had
antitumor effects in other cancer types including preclinical human
models for triple negative breast cancer, ovarian cancer and
pancreatic cancer. VERU-111 has the potential to be the first FDA
approved selective antitubulin agent that targets and disrupts
alpha and beta tubulin subunits of microtubules to treat
cancer.
About Zuclomiphene CitrateZuclomiphene citrate
(VERU-944) is a novel, proprietary, oral, nonsteroidal, estrogen
receptor agonist being evaluated in a Phase 2 clinical study to
treat hot flashes, one of the most common side effects caused by
androgen deprivation therapy (ADT), or hormone treatment for men
with advanced prostate cancer. The Phase 2 clinical trial will
enroll approximately 120 men in over 15 clinical sites in the
United States. Zuclomiphene citrate has the potential to be the
first FDA approved drug for hot flashes caused by prostate cancer
hormone therapy. It is estimated that there are over 600,000 men in
the US on ADT and about 30% of them suffer from moderate to severe
hot flashes. Concern over hot flashes make men less likely to begin
ADT and can lead to early discontinuation of this effective
prostate cancer therapy. Based on an independent market analysis
sponsored by the Company, the Company estimates the US market
potential for zuclomiphene citrate is over $600 million
annually.
About Veru Inc.Veru Inc. is an oncology
and urology biopharmaceutical company developing novel urology
specialty pharmaceuticals and medicines for the prostate cancer
continuum of care. The Veru prostate cancer pipeline
includes zuclomiphene citrate (also known
as VERU-944, cis-clomiphene)
and VERU-111 (bisindole). Zuclomiphene citrate is an estrogen
receptor agonist being evaluated in a Phase 2 trial to treat hot
flashes, a common side effect caused by hormone treatment for men
with advanced prostate cancer. VERU-111 is an oral,
next-generation, first-in-class selective small molecule that
targets and disrupts alpha and beta subunits of microtubules in
cells to treat metastatic prostate cancer patients whose disease is
resistant to both castration and novel androgen blocking agent
(abiraterone or enzalutamide) therapies. Veru expects to
enroll the first patient in the VERU-111 Phase 1b/2 clinical trial
in January 2019.
Veru is also advancing new drug formulations in its
specialty pharmaceutical pipeline addressing unmet medical needs in
urology. Tamsulosin DRS granules and Tamsulosin XR capsules are
formulations of tamsulosin, the active ingredient in FLOMAX®, which
Veru has developed to avoid the “food effect” inherent in currently
marketed formulations of the drug, allowing for potentially safer
administration and improved patient compliance (NDA submission
expected in 2019). Veru is also developing Tadalafil/Finasteride
combination tablet. Tadalafil (CIALIS®) is currently approved for
treatment of BPH and erectile dysfunction and finasteride (PROSCAR®
and PROPECIA®) is currently approved for treatment BPH and male
pattern hair loss. The co-administration of tadalafil and
finasteride has been shown to be more effective for the treatment
of BPH than either drug alone*(NDA submission expected in
2019).
Veru’s Female Health Company Division markets the FC2 Female
Condom / FC2 Internal Condom®, an FDA-approved product for the dual
prevention of unwanted pregnancy and sexually transmitted
infections, and the PREBOOST® medicated individual wipe for the
prevention of premature ejaculation. The FC2 Female Condom / FC2
Internal Condom is marketed commercially and in the public health
sector both in the U.S. and globally. FC2 is available by
prescription in the U.S. including through the virtual doctor
smartphone app “HeyDoctor” at www.fc2.us.com. FC2 improves the
lives, health and well-being of women around the world. For
PREBOOST® Veru has a co-promotion and distribution agreement with
Timm Medical Technologies, Inc., a specialty urology sales
organization, and the Company also recently entered into a US
distributor agreement with a premier and fast-growing men’s health
and telemedicine company that discreetly sells men’s health
products via the internet. To learn more about these products
please visit www.verupharma.com.
"Safe Harbor" statement under the Private Securities
Litigation Reform Act of 1995:The statements in this
release that are not historical facts are "forward-looking
statements" as that term is defined in the Private Securities
Litigation Reform Act of 1995. Forward-looking statements in this
release include statements relating to the regulatory pathway to
secure FDA approval of the Company's drug candidates, the
anticipated timeframe for clinical studies, clinical study results
and FDA submissions and the market potential for the Company’s drug
candidates. Any forward-looking statements in this release are
based upon the Company's current plans and strategies and reflect
the Company's current assessment of the risks and uncertainties
related to its business and are made as of the date of this
release. The Company assumes no obligation to update any
forward-looking statements contained in this release because of new
information or future events, developments or circumstances. Such
forward-looking statements are subject to known and unknown risks,
uncertainties and assumptions, and if any such risks or
uncertainties materialize or if any of the assumptions prove
incorrect, our actual results could differ materially from those
expressed or implied by such statements. Factors that may cause
actual results to differ materially from those contemplated by such
forward-looking statements include, but are not limited to, the
following: risks related to the development of the Company's
product portfolio, including clinical trials, regulatory approvals
and time and cost to bring to market; potential delays in the
timing of and results from clinical trials and studies and the risk
that such results will not support marketing approval and
commercialization; potential delays in the timing of any submission
to the FDA and regulatory approval of products under development;
risks relating to the ability of the Company to obtain sufficient
financing on acceptable terms when needed to fund development and
operations; product demand and market acceptance; competition in
the Company's markets and the risk of new or existing competitors
with greater resources and capabilities and new competitive product
introductions; price erosion, both from competing products and
increased government pricing pressures; manufacturing and quality
control problems; compliance and regulatory matters, including
costs and delays resulting from extensive governmental regulation,
and effects of healthcare insurance and regulation, including
reductions in reimbursement and coverage or reclassification of
products; some of the Company's products are in development and the
Company may fail to successfully commercialize such products; risks
related to intellectual property, including the uncertainty of
obtaining patents, the effectiveness of the patents or other
intellectual property protections and ability to enforce them
against third parties, the uncertainty regarding patent coverages,
the possibility of infringing a third party’s patents or other
intellectual property rights, and licensing risks; government
contracting risks, including the appropriations process and funding
priorities, potential bureaucratic delays in awarding contracts,
process errors, politics or other pressures, and the risk that
government tenders and contracts may be subject to cancellation,
delay, restructuring or substantial delayed payments; a
governmental tender award indicates acceptance of the bidder's
price rather than an order or guarantee of the purchase of any
minimum number of units, and as a result government ministries or
other public sector customers may order and purchase fewer units
than the full maximum tender amount or award; penalties and/or
debarment for failure to satisfy tender awards; the Company's
reliance on its international partners and on the level of spending
by country governments, global donors and other public health
organizations in the global public sector; risks related to
concentration of accounts receivable with our largest customers and
the collection of those receivables; the economic and business
environment and the impact of government pressures; risks involved
in doing business on an international level, including currency
risks, regulatory requirements, political risks, export
restrictions and other trade barriers; the Company's production
capacity, efficiency and supply constraints and interruptions,
including due to labor unrest or strikes; risks related to the
costs and other effects of litigation, including product liability
claims; the Company's ability to identify, successfully negotiate
and complete suitable acquisitions or other strategic initiatives;
the Company's ability to successfully integrate acquired
businesses, technologies or products; and other risks detailed in
the Company's press releases, shareholder communications and
Securities and Exchange Commission filings, including the Company's
Form 10-K for the year ended September 30, 2018. These documents
are available on the "SEC Filings" section of our website at
www.verupharma.com/investors.
Contact:Kevin Gilbert786-322-2213
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