- Lead
product candidate, PRO 140, is a viral-entry inhibitor that works by
blocking the entry of HIV/AIDS to healthy cells by masking CCR5 receptor
- Completion
of Biological License Application (BLA) for potential approval in
combination HIV therapy expected in Q1 2019
- CytoDyn
received approval to increase dosing of PRO 140 in its phase 3 adaptive
clinical trial for enrolled HIV/AIDS patients
- Market
potential for PRO 140 as an anti-viral agent in combination with HAART is
$1.2 billion; as a monotherapy maintenance/single-drug therapy, the market
is estimated at $3.8 billion
- Acquisition
of privately held ProstaGene expected to complete in November, giving
CytoDyn access to CCR5 technologies related to cancer
- PRO
140 set for Investigational New Drug (IND) application in first cancer
indication
Biotechnology company CytoDyn Inc. (OTCQB: CYDY) is focused
on providing real hope and help to the millions of people infected with the
human immunodeficiency virus (HIV) and those suffering from several devastating
forms of cancer. The company’s lead product candidate, PRO 140 (leronlimab), is
in advanced stages of clinical development as a therapy for HIV/AIDS, and plans
to expand investigations with PRO 140 into cancer are underway. Nader
Pourhassan, Ph.D., president and CEO of CytoDyn, updated shareholders during a
recent conference call that was highlighted in a corporate summary from leading
independent small cap media portal EmergingGrowth.com (http://ibn.fm/OarFS).
The summary includes highlights from the ongoing clinical
development of CytoDyn’s PRO 140 viral-entry inhibitor, which has demonstrated
a 93 percent suppression rate in 525mg trials after a six-week induction period
of enrolled HIV/AIDS patients. The data suggests that the higher the dosage of
PRO 140, the quicker the drug drives a durable response, with a lower
probability of a viral rebound, EmergingGrowth.com’s summary states.
HIV targets the immune system and weakens the body’s defense
systems against infections and some types of cancer. During 2017, some 1.8
million people became newly infected with HIV, bringing the global total to
36.9 million people living with HIV, according to the World Health
Organization (http://ibn.fm/udfzb).
HIV continues to be a major public health issue, having claimed more than 35
million lives so far from every corner of the world. The market potential for
PRO 140 used as an anti-viral agent in combination with a patient’s current HIV
regimen (Highly Active Antiretroviral Therapy, or “HAART”) is $1.2 billion; as
a monotherapy maintenance/single-drug therapy, the market is estimated at $3.8
billion.
CytoDyn also recently signed a definitive agreement to
acquire privately held ProstaGene. The deal, expected to be finalized in
November, transfers or assigns to CytoDyn certain intellectual property rights
held by ProstaGene and its founder and CEO Richard G. Pestell, M.D., Ph.D.,
M.B.A., F.A.C.P., F.R.A.C.P., who has joined CytoDyn as its interim chief
medical officer (http://ibn.fm/JMWyC). ProstaGene
is developing metastasis-control technology that targets the chemokine receptor
type 5 (CCR5), a protein on the surface of white blood cells. Metastasis is the
spread of cancer beyond the original tumor, a phenomenon that contributes to
the disease’s deadliness. Preclinical studies have suggested that the use of
CCR5 antagonists, such as PRO 140, as adjuvants may bolster anti-tumor immune
responses.
“We are honored to soon have world-renowned cancer
researcher Dr. Richard Pestell join CytoDyn as our Chief Medical Officer, with
responsibility for leading all PRO 140 programs in non-HIV indications,”
Pourhassan said in a news release. “We also have taken this important next step
to acquire ProstaGene, which will allow Dr. Pestell to accelerate his CCR5
antagonist research related to cancer. As previously stated, our objective is
to evaluate PRO 140 in expanded indications including certain cancers and
immunological indications concurrent with advancing our promising HIV
programs.”
CytoDyn has been conducting recent efforts to generate
capital through the sale of shares and the exploration of non-dilutive
licensing pathways and acquisition of related licensing rights for ProstaGene’s
innovative prostate cancer prognostic test. The company expects this genetic
test to add significantly to the company’s portfolio and, if successfully
commercialized, to compete favorably with existing marketed prognostic cancer
tests “that the competitor sells for $3,000.”
For more information, visit the company’s website at www.CytoDyn.com
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