VANCOUVER, Wash., July 31, 2014 (GLOBE NEWSWIRE)
-- CytoDyn Inc. (OTCQB:CYDY), a biotechnology
company focused on the development of new therapies for combating
infection with human immunodeficiency virus (HIV), today announced
positive interim results from its Phase 2b treatment substitution
study. The Company will hold an investment community conference
call on August 4, 2014, at 9:00 a.m. PT to discuss the trial's
protocol, clinical results, and anticipated path forward, as well
as to address questions from the call's participants.
This Phase 2b study was designed to investigate the potential
for weekly injections of PRO 140, a fully humanized monoclonal
antibody, to substitute for a patient's current drug regimen to
allow a drug holiday.
The study is to enroll 40 patients in two cohorts, the first
with 12 patients followed by a second cohort of 28 patients based
on initial safety and efficacy data. All potential study
patients are screened and for entry must be HIV positive with the
type of virus, 'R5', that uses the coreceptor CCR5 for cell entry
and infection. Patients that have a strain of HIV, 'X4', that
uses the other coreceptor, CXCR4, are excluded as PRO 140 is not
effective in those patients. Dr. Nader Pourhassan, President
and CEO, commented, "Currently, there are over 30 drugs approved
for HIV/AIDS treatment, but all are believed to have common
problems such as drug resistance, side effects with long-term
morbidities and a requirement for daily, life-long
adherence. We are encouraged by the possibility that PRO 140
may offer these patients the potential to take a sustained drug
holiday from their daily regimen of drugs and to improve overall
patient health."
The study was initiated on May 13, 2014 and the 12th patient
received an initial injection on June 5, 2014. Each patient
continued the normal drug regimen plus PRO 140 for the first week,
which was then followed by up to 12 weeks of PRO 140
monotherapy. The clinical trial required oversight by an
independent Data Safety Monitoring Board ("DSMB") to ensure patient
safety and to assess efficacy. The DSMB operates in conformance
with the FDA guidelines for its independence, management and
oversight. The interim clinical trial results are summarized
to date as follows:
- The DSMB met on June 27, 2014 to review the data from the first
cohort of 12 patients and noted no adverse reactions or side
effects after three weeks of treatment. The DSMB unanimously
recommended that the Company proceed to enroll the next 28-patient
cohort to complete the 40-patient study. The DSMB will review
the safety and efficacy of the study for the second time on August
13, 2014.
- After four weeks of PRO 140 monotherapy, no patient experienced
virologic failure.
- Half the patients maintained suppressed viral loads after 8
weeks of monotherapy.
- Five patients, however, experienced virologic failures.
The first of these 'failures' was documented to be a patient
qualification screen failure rather than a drug failure. The
Company believes that this is a likely cause in the other failures.
- Virologic failures occurred as follows: three patients
failed after 5 weeks of monotherapy, one failed after 6 weeks of
monotherapy and one patient failure occurred after 7 weeks of
monotherapy.
One inclusion criterion for this study required each patient to
have an undetectable viral load for the 12 months prior to
enrollment. As only HIV patients who have R5 virus
exclusively can benefit from PRO 140, each patient is required to
take a DNA Trofile test prior to enrollment in the study. However,
this test is only about 50% accurate in patients with an
undetectable viral load. Therefore, the Company expected to
observe a number of viral rebounds due to inaccurate trofile
screening as observed thus far. Of the five patients who
demonstrated a rebound in their viral load, one patient has been
retested and the test results concluded the patient had a
"Dual/Mixed Tropic" HIV-1 virus and should have been excluded from
the study. The other four patients have been retested for the
qualifying R5 exclusive virus and results are expected
shortly. CytoDyn is currently investigating the possibility of
developing a more accurate screening test for R5 exclusive virus
among patients with undetectable virus.
Dr. Pourhassan added, "Based on the first cohort of patients,
our treatment substitution study has yielded the following results:
first, the DSMB recommended the enrollment of the second
patient cohort based on safety and efficacy indications after three
weeks of PRO 140 therapy; second, none of the patients demonstrated
viral load failures during the first four weeks of monotherapy; and
third, half of the patients did not demonstrate a viral load
failure during eight weeks of monotherapy. We believe PRO 140
may prove to be a potential new therapy for HIV patients who need
to cycle off conventional treatment regimens."
About PRO 140
PRO 140 belongs to a new class of HIV/AIDS therapeutics --
viral-entry inhibitors -- that are intended to protect healthy
cells from viral infection. PRO 140 is a humanized monoclonal
antibody directed against CCR5, a molecular portal that HIV uses to
enter cells.
PRO 140 has been the subject of four Phase 1/1b and two Phase 2a
clinical trials, each of which demonstrated its ability to
significantly reduce HIV viral load in human test subjects, and has
also been designated a "fast track" product candidate by the
FDA. The PRO 140 antibody appears to be a powerful antiviral
agent leading to potentially fewer side effects and less frequent
dosing requirements as compared to daily drug therapies currently
in use.
About CytoDyn
CytoDyn is a biotechnology company focused on developing
subcutaneously delivered humanized cell-specific monoclonal
antibodies (mAbs) as entry inhibitors for the treatment and
prevention of Human Immunodeficiency Virus (HIV). The Company has
one of the leading mAbs under development for HIV infection, PRO
140, which is a Late Stage 2 humanized mAb with demonstrated
antiviral activity in man. PRO 140 blocks the HIV co-receptor CCR5
and clinical trial results thus far indicate that it does not
affect the normal function of the cell. Results from Phase 1/1b and
Phase 2a human clinical trials have shown that PRO 140 can
significantly reduce viral burden in people infected with
HIV. CytoDyn intends to continue to develop PRO 140 as a
therapeutic anti-viral agent in persons infected with HIV. For more
information on the Company please visit www.cytodyn.com.
Forward-Looking Statements
This press release includes forward-looking statements and
forward-looking information within the meaning of United States
securities laws. These statements and information represent
CytoDyn's intentions, plans, expectations, and beliefs and are
subject to risks, uncertainties and other factors, many beyond
CytoDyn's control. These factors could cause actual results
to differ materially from such forward-looking statements or
information. The words "believe," "estimate," "expect,"
"intend," "attempt," "anticipate," "foresee," "plan," and similar
expressions and variations thereof identify certain of such
forward-looking statements or forward-looking information, which
speak only as of the date on which they are made.
CytoDyn disclaims any intention or obligation to publicly update
or revise any forward-looking statements or forward-looking
information, whether as a result of new information, future events
or otherwise, except as required by applicable law. Readers
are cautioned not to place undue reliance on these forward-looking
statements or forward-looking information. While it is
impossible to identify or predict all such matters, these
differences may result from, among other things, the inherent
uncertainty of the timing and success of and expense associated
with research, development, regulatory approval, and
commercialization of CytoDyn's products and product candidates,
including the risks that clinical trials will not commence or
proceed as planned; products appearing promising in early trials
will not demonstrate efficacy or safety in larger-scale trials;
future clinical trial data on CytoDyn's products and product
candidates will be unfavorable; funding for additional clinical
trials may not be available; CytoDyn's products may not receive
marketing approval from regulators or, if approved, may fail to
gain sufficient market acceptance to justify development and
commercialization costs; competing products currently on the market
or in development may reduce the commercial potential of CytoDyn's
products; CytoDyn, its collaborators or others may identify side
effects after the product is on the market; or efficacy or safety
concerns regarding marketed products, whether or not scientifically
justified, may lead to product recalls, withdrawals of marketing
approval, reformulation of the product, additional pre-clinical
testing or clinical trials, changes in labeling of the product, the
need for additional marketing applications, or other adverse
events.
CytoDyn is also subject to additional risks and uncertainties,
including risks associated with the actions of its corporate,
academic, and other collaborators and government regulatory
agencies; risks from market forces and trends; potential product
liability; intellectual property litigation; environmental and
other risks; and risks that current and pending patent protection
for its products may be invalid, unenforceable, or challenged or
fail to provide adequate market exclusivity. There are also
substantial risks arising out of CytoDyn's need to raise additional
capital to develop its products and satisfy its financial
obligations; the highly regulated nature of its business, including
government cost-containment initiatives and restrictions on
third-party payments for its products; the highly competitive
nature of its industry; and other factors set forth in CytoDyn's
Annual Report on Form 10-K for the fiscal year ended May 31, 2014
and other reports filed with the U.S. Securities and Exchange
Commission.
CONTACT: Investor Relations
Porter, LeVay & Rose, Inc.
Michael J. Porter, President
Office: (212) 546-4700
E-mail: mike@plrinvest.com
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