New HIV Self-Injectable Drug Receives

Green Light From FDA For Phase 3

Clinical Trials PRO 140 Could Get
Fast-Track FDA Approval
By David Drake

#hiv has plagued the United States women and children alike for the last few decades. I never
thought we would actually see a potential antidote to permanently suppress or even eradicate HIV
(Human Immunodeficiency Virus) in my lifetime. That is until I came across a new biotech
company that has developed the first self-administered, injectable antibody for HIV patients
worldwide. The #fda has given PRO 140 a fast tracking designation and possibility of accelerated
approval. Furthermore, the FDA just gave the phase 3 plan a green light and asked to receive the
full protocol.

Today HIV is not a death sentence like it once was thanks to one man, Dr. David Ho. In 1996, he
created the Highly Active Antiretroviral Therapy or HAART that is the base foundation for modern
HIV treatment. We saw its first go to work on NBA hall of famer Magic Johnson more than 20 years

ago and today Mr. Johnson is still his competitive self. It was first developed as a 3 drug regimen
program with 2 different classes of daily pills taken for life.

Its taken nearly 30 years but there is a new company making treatment of HIV easier and less
invasive of a lifestyle change. The company is CytoDyn Inc. (OTCQB: CYDY), and they offer HIV
patients a new alternative to the pills regimen with their PRO 140 weekly HIV antibody injection . I
just got a chance to interview CytoDyn President and CEO Dr. Nader Pourhassan.

The US had about 56,000 new HIV cases in 2014 said Nader Pourhassan as we started talking. I
grew up during the Acquired Immunodeficiency Syndrome (AIDS) epidemic and have endlessly
and constantly worried about it. The fear of HIV and AIDS has always been a looming present
threat and danger all my adult life, but not anymore.

Cytodyn finally may have an alternative to pills with PRO 140 as it just passed phase 2b FDA
Clinical trials with a staggering 98% success rate. It is now facing a 25 week phase-3 clinical trial
that could put this medicine on store shelves to give HIV patients a new option than just oral
regimen.

How does it work? Fourteen (14) patients from the 40 persons that participated in the recently
concluded phase 2b trial were allowed to continue taking the once a week self-administered
injections of PRO 140. The antibody PRO 140 prevents HIV to bind to CCR5, co-receptor by simply
binding to this co-receptor the HIV uses to enter and infect cells. It is like you are at a red stop
light and the light never turns to green. The result is that the last years new HIV cases in the US
could one day potentially have such a low virus count that they cannot infect anyone. Moreover,
these HIV patients will have their own exposure in remission maintained.

How big of a concern is HIV business today, its a $15 billion annual industry in US and EU. Just
over

1.1

million

Americans

have

HIV

while

56,000

new

cases

were

added

in

2014.

People with HIV will not be cured, yet they have to take several pills everyday just to fight HIV and
AIDS, to stay alive. The current HAART program being used by HIV/AIDS patients has drawbacks,
and poses three challenges:

Some of these drugs become toxic and patients face new exposure to dying; HIV grows resilient
against medications and their combination, so a new format of medication has to be created to
fight HIV.
If and when the patients forget to take a single one of their daily HIV pills, it renders the whole
program dysfunctional and the HIV infection count increases.
With the PRO 140 once a week injection process, the patient may forget one day without
jeopardizing their HIV count reduction. Moreover, the side effects of nausea and sleep deprivation
have significantly improved with less pills challenging and damaging the bodys immune system.

Pfizer (NYSE: PFE) offers Selzentry (Maraviroc) as a pill in the HIV inhibitors market. However, its
side effects include liver toxicity, heart problems that may lead to heart attacks and low blood
pressure when standing up (postural hypotension). Interestingly enough, a 2013 report published
by Red Orbit from New York University School of Medicine found Selzentry combat the deadly
Staph disease (Staphylococcus bacteria) so both drugs may have additional applications.

The PRO 140 promises to reduce the HIV count in patients. The low count of infection will even
prevent potentially the disease to spread through fluid interactions with other persons.
Consequently, CytoDyns phase 2b clinical trial, give patients a drug holiday from all their pills and
allow them to be only on PRO 140 once a week injection. With 98 percent success rate for one
month drug holiday, and with the 14 patients that have continued to use it after the said trial, now
on its 8 months trailing, and seeing success at controlling the virus without any pills (HAART).
After the phase 2a clinical trial back in 2006, PRO 140 obtained the FDA fast track designation and
National Institute of Health (NIH) funding of over $20MM in last 12 years due to the following
reasons:

PRO 140 stops HIV replication without stopping any of the immune function

Prolonged antiviral activity and tolerability

different resistance profile compared to any HIV drug

hardly any toxicity (unlike all HAART drugs)

almost no side effects (unlike all HAART drugs)

Its clear, the next step in reducing and containing todays outbreak of HIV is to simplify the
medication process until a cure if discovered, and PRO 140 promises to fill that easy to use
solution for HIV carriers gap. Im not yet relieved but I have hope.
Note: This article originally appeared on HedgeCo 6/13/2015

http://www.hedgeco.net/blogs/2015/06/13/new-hiv-self-injectable-drug-receives-green-lightfrom-fda-for-phase-3-clinical-trials-pro-140-could-get-fast-track-fda-approval/

David

Drake

is

the

Chairman

of LDJ

Capital,

private

equity

advisory; Victoria Partners, a 110 family office network; Drake Hospitality

Group; and The Soho Loft Media Group with divisionsVictoria Global
Communications, Times

Impact

Publications,

and The

Conferences. Reach him directly at David@LDJCapital.com.

Soho

Loft