Veru Advances Novel, First-in-Class Oral Tubulin Inhibitor for Refractory Metastatic Prostate Cancer
November 13 2018 - 8:30AM
-- Submits Investigational New Drug Application
to FDA --
Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical
company, today announced that it has submitted an Investigational
New Drug (IND) application with the U.S. Food and Drug
Administration (FDA) for VERU-111 (bisindole), a first-in-class,
next generation, proprietary, oral tubulin inhibitor for the
treatment of refractory metastatic prostate cancer. The Company
plans to conduct an open label Phase 1b/2 clinical trial in men
with metastatic castration resistant prostate cancer that have also
become resistant to, or who have failed to respond to, abiraterone
or enzalutamide.
“Submission of this IND is an important milestone in advancing
into humans VERU-111 -- a first-in-class, next generation,
proprietary, oral tubulin inhibitor. VERU-111 is being developed
for men who have metastatic castration resistant prostate cancer
that have also become refractory to, or who have failed to respond
to, abiraterone or enzalutamide. This group of men may be the
largest growing segment of advanced prostate cancer unmet need.
These men with refractory prostate cancer are now being offered
intravenous administration of anti-tubulin taxanes that can have
significant safety limitations like hypersensitivity,
myelosuppression (neutropenia) and neurotoxicity,” commented
Mitchell Steiner, M.D., Chairman, President and Chief Executive
Officer of Veru.
“Based on our extensive preclinical experience, we believe
VERU-111 should demonstrate significant antitumor activity against
metastatic castration and novel androgen blocking agent
(enzalutamide or abiraterone) resistant prostate cancers with oral
dosing and a favorable safety profile. We expect to begin an open
label Phase 1b/2 clinical trial before the end of 2018. The open
label design of the trial means that we will have safety and
efficacy data as early as the first half of calendar year
2019.”
About VERU-111
VERU-111 is a novel, next generation oral anti-tubulin therapy
that targets alpha and beta tubulin subunits. In animal models,
VERU-111 delivered by oral administration demonstrated significant
anti-tumor activity in models of metastatic, castration and novel
androgen blocking agent (abiraterone or enzalutamide) resistant
prostate cancer. In the preclinical toxicology studies, VERU-111,
at oral doses that had significant antitumor effects, did not
result in neutropenia or myelosuppression, common dose limiting
side effects of other antitubulins including intravenous taxanes or
intravenous vinca alkaloids. Also, VERU-111 had antitumor
effects in other cancer types including preclinical human models
for triple negative breast cancer, ovarian cancer and pancreatic
cancer.
About Veru Inc.Veru Inc. is an oncology
and urology biopharmaceutical company developing novel medicines
for prostate cancer and prostate cancer supportive care as well as
near term specialty pharmaceuticals to address significant unmet
needs in urology.
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, agent that targets alpha and beta subunits caused
by cells to form cellular microtubules to treat castration and
novel androgen blocking agent (abiraterone or enzalutamide)
resistant metastatic prostate cancer that Veru expects to
enter Phase 1b/2 development in late 2018.
Veru is also advancing four 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, a super selective alpha-1 adrenergic
receptor antagonist for the treatment of benign prostatic
hyperplasia (BPH), that avoid the “food effect” 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 tablets for inhibition of both phosphodiesterase type 5
(PDE5) and 5-alpha-reductase to shrink an enlarged prostate, treat
symptoms of BPH and to treat erectile dysfunction (NDA submission
expected in 2019). Finally, Veru is developing Solifenacin DRG
granules, a formulation of a selective M3 muscarinic receptor
antagonist for the treatment of overactive bladder in patients who
have difficulty with swallowing tablets (NDA submission expected in
2019).
Veru’s currently marketed products are the PREBOOST® medicated
individual wipe for the prevention of premature ejaculation and the
FC2 Female Condom®. The Female Health Company Division markets the
FC2 Female Condom® in the global public health sector to improve
the lives, health and well-being of women around the world. To
learn more 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 and the
anticipated timeframe for clinical studies, clinical study results
and FDA submissions. 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, 2017. These documents
are available on the "SEC Filings" section of our website at
www.verupharma.com/investors.
Contact:Kevin Gilbert 786-322-2213
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