Veru has Successful Pre-IND Meeting with FDA for VERU-111 Next Generation Novel Oral Anti-Tubulin Therapy for Metastatic Pros...
September 12 2018 - 8:00AM
Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical
company, announced today that it has completed a
Pre-Investigational New Drug Application (pre-IND) meeting for
VERU-111 in which the Food and Drug Administration (FDA) agreed
with Veru’s plans for a Phase 1/2 clinical trial and that an IND
may be submitted for the indication of men who have metastatic
castration resistant prostate cancer and who have also become
resistant to, or who have failed to respond to, ZYTIGA®
(abiraterone) or XTANDI® (enzalutamide).
“We had a successful pre-IND meeting with the FDA
and anticipate submitting the IND and then initiating an open label
Phase 1/2 clinical trial by the end of the year,” said Dr. Mitchell
Steiner, Chairman, President, and CEO of Veru Inc. “An open label
study means that every patient will receive VERU-111 and so we
expect to have an early assessment of safety and efficacy by the
early part of 2019. We plan to work closely with Johns
Hopkins University and other highly regarded clinical sites to
conduct this study.” VERU-111 is a novel, next generation oral
anti-tubulin therapy that targets alpha and beta tubulin subunits
of microtubules. In animal models, VERU-111 as an oral
anti-tubulin, 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 which comprise the IND package,
there was no observed neutropenia or myelosuppression. These are
common dose limiting side effects of other anti-tubulins like IV
taxanes or IV vinca alkaloids. Also, VERU-111 had anti-tumor
effects in preclinical 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 (aka 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
who have advanced prostate cancer. VERU-111 is an oral,
next-generation, first-in-class, antitubulin agent targeting alpha
and beta tubulin of microtubules to treat castration and novel
androgen blocking agent (abiraterone or enzalutamide) resistant
metastatic prostate cancer that Veru expects to enter
Phase 1/2 development in late 2018.
Veru is advancing four new drug formulations in its
specialty pharmaceutical pipeline addressing unmet medical needs in
urology. Tamsulosin DRS granules and XR capsules are formulations
of a super selective alpha-1 adrenergic receptor antagonist for the
treatment of benign prostatic hyperplasia (BPH) without a food
effect, allowing for potentially safer administration and improved
drug compliance (NDA submission expected in 2019).
Tadalafil/finasteride combination tablets are for inhibition of
both phosphodiesterase type 5 (PDE5) and 5-alpha-reductase to
shrink an enlarged prostate, treat symptoms of BPH and treat
erectile dysfunction (NDA submission expected in 2019). Solifenacin
DRG slow release granules are 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).
Marketed products include the PREBOOST® medicated 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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