Hollis-Eden Pharmaceuticals Receives Clearance From the South African
Government to Initiate Additional HIV Clinical Trials
SAN DIEGO, Sept. 27 /PRNewswire/ -- Hollis-Eden Pharmaceuticals, Inc.
(Nasdaq: HEPH) today announced clearance from the South African Medicines
Control Council (MCC) for the Company to initiate additional clinical studies
in HIV infected patients with HE2000, its lead investigational drug candidate.
These new studies include a Phase II pilot trial to assess the ability of
HE2000 to delay the onset of opportunistic infections in patients in the late
stages of HIV infection. A Phase I/II trial utilizing a new subcutaneous
formulation of HE2000 in treatment naive HIV infected patients has also been
approved. In addition, the MCC has cleared Hollis-Eden, in its ongoing
initial Phase I/II clinical trial, to provide continued access to HE2000
therapy beyond the planned one-year stopping point for patients continuing to
show benefit from treatment.
"We are very pleased that the MCC has notified us today that we are
cleared to move forward into these additional studies," stated Richard B.
Hollis, Chairman and CEO of Hollis-Eden. "Our corporate vision for HE2000 is
to provide a cost-effective drug that corrects immune dysregulation and allows
the immune system to mount an appropriate response to control, delay, or
prevent the onset of HIV disease progression to AIDS and potentially fatal
opportunistic infections. Given that HE2000 is cost-effective to manufacture
and administer, is unlikely to lead to the development of resistance and to
date is demonstrating an attractive safety profile, we believe it could be
well suited for both developed and developing countries. Our objective in
treating HIV is to work with governments and various charitable institutions
to commercialize a world compound that truly addresses the epidemic by making
the drug accessible to all people that are infected with the virus in
countries such as South Africa. As a result of our preclinical and clinical
experience to date, we are planning to continue our efforts and work
cooperatively with health officials in South Africa to generate the scientific
data necessary to establish HE2000 as a safe, efficacious drug with the
potential to provide clinical benefit to millions suffering from a variety of
infectious diseases. Hollis-Eden's goal is to become the world leader in
addressing infectious diseases and immune systems disorders by re-establishing
the body's ability to mount an appropriate immune response."
The Phase II pilot study in late-stage HIV infected patients is designed
to evaluate the safety, tolerability, immune effects and activity of HE2000 in
40 HIV infected patients with CD4 cells less than 100 cells/ml who will be
randomly assigned to either a treatment or a placebo control group. The study
will determine the disease-specific incidence rate of opportunistic infections
for both groups while they receive treatment. The active treatment group will
receive a treatment course of 100 mg/ml of HE2000 injected once each day for
5 consecutive days, while the control group will receive a placebo without the
active pharmaceutical ingredient. This treatment course of 5 daily injections
will be repeated every 6 weeks, for a total of up to 7 courses over 42 weeks.
An independent safety and data monitoring panel will assess the results as the
study progresses.
"We are very excited to study the clinical benefits of HE2000 in these
additional trials," stated James Frincke, Executive Vice President of R&D at
Hollis-Eden. "The immune system changes seen thus far in our clinical work in
patients participating in our South African trial suggest that HE2000 may be
of benefit in delaying the onset of AIDS-defining opportunistic infections.
We are also looking forward to the results of the subcutaneous study. Pain
and inflammation at the injection site has been the only drug-related serious
adverse event reported from this clinical trial to date, and we believe this
new formulation may reduce this side effect. In addition, our preclinical
work indicates that there may be some additional therapeutic benefit to
administering the drug by the subcutaneous route in HIV patients."
In the immune system, two types of immunity exist in balance: cell
mediated (Th1) and humoral (Th2). Th1 immunity is useful against
intracellular pathogens such as viruses, certain parasites, and some tumor
cells. Th2 immunity includes antibody responses to circulating pathogens such
as bacteria, as well as viruses. Reports in the medical literature indicate
that HIV-infected patients that tend not to progress in the disease have a
stronger Th1 response, while those that progress faster towards AIDS have a
predominant Th2 response.
Hollis-Eden recently presented preliminary findings from its ongoing HIV
trial in South Africa at the World AIDS Conference in Durban, South Africa,
held July 9-14. The preliminary analysis from this ongoing trial indicates
that these HIV-infected South African patients had progressed to a
predominately Th2 immune response prior to treatment with HE2000, and then
shifted back to an appropriate Th1 response after treatment with HE2000.
Thus, HE2000 has appeared to rebalance the immune system in these patients.
In addition, key immune cell subsets were stimulated in these patients,
including activated killer T-cells, natural killer cells, lymphocyte activated
killer cells and dendritic cells. Given these results, the Company believes
there may also be an opportunity for HE2000 to be used in slowing or halting
disease progression in earlier-stage patients. Hollis-Eden plans to explore
this opportunity in an additional clinical trial in the future.
In addition to initiating these clinical studies in HIV, as previously
announced Hollis-Eden is awaiting clearance from the MCC in South Africa
to initiate one of a series of planned clinical studies with HE2000 in
malaria-infected patients. Additional clinical studies outside the
United States are also planned for patients infected with hepatitis B and
hepatitis C. |
