WILMINGTON, Del.--(BUSINESS WIRE)--Jan. 12, 1998--VIMRX
Pharmaceuticals Inc. (NASDAQ:VMRX.O) today announced a year-end
evaluation of VIMRxyn(R)(synthetic hypericin) in several
applications.
Two research programs will continue to advance through
development, including the use of VIMRxyn(R) to treat glioblastoma,
a highly malignant form of brain tumors, and VIMRxyn(R)'s use as a
topically applied, light-activated therapy for specific skin diseases
including psoriasis, cutaneous T-cell lymphoma and warts. VIMRX has
decided to discontinue three research programs targeting the use of
VIMRxyn(R) for the treatment of HIV, Hepatitis C and blood
sterilization due to inadequate efficacy at tolerable doses.
"In mid-1996, VIMRX initiated a major effort to diversify and
strengthen its portfolio of technologies and businesses -- an effort
that has been very successful," said Dr. David A. Jackson, Chief
Scientific Officer of VIMRX. "The hypericin development strategy has
been to obtain clinical data for a number of applications in order to
determine those with the greatest potential to succeed in improving
human health, and the optimal ones on which to focus resources. The
available data have led to decisions to continue clinical development
of VIMRxyn(R) as a treatment for glioblastoma and for several
applications of topical phototherapy. At the same time, the data do
not provide a rationale for continued development of hypericin for
three other applications -- treatment of HIV, hepatitis C virus, and
blood collected for transfusion -- and these programs will
consequently be terminated."
I. Two Clinical Programs Indicate Positive Benefit of
VIMRxyn(R) for Treatment of Glioblastoma and Skin Diseases
Glioblastoma: Preliminary Results Show Benefit in Tumor Stability
and Tumor Reduction.
VIMRX is conducting an ongoing Phase I/II clinical trial to
evaluate the safety and efficacy of synthetic hypericin in treating a
highly malignant form of brain tumors, glioblastoma multiforme, for
which no effective therapy currently exists. A formal analysis of
the clinical data will be performed when 16 evaluable patients have
completed the study, evaluable patients being those who have
completed three months of treatment with VIMRxyn(R) administered orally
once daily. Twenty-one patients have been enrolled in the study
thus far. VIMRX has been and will continue to extend treatment beyond
three months for responding patients. Contingent on the outcome of a
formal analysis of all evaluable patients, VIMRX plans a Phase II,
multi-center study to be initiated in mid-1998.
Investigators continue to enroll patients into the study in order
to accrue the 16 patients on medication for three months necessary to
evaluate drug efficacy. The six clinical study sites include New
York Medical College in Valhalla, Walt Disney Memorial Cancer Center
in Orlando, Tom Baker Cancer Center in Calgary, Canada, USC
University Hospital in Los Angeles, University of Washington in
Seattle, and the Trinity Medical Center in Minot, North Dakota.
Skin Diseases: Topical Phototherapy Phase II Study Underway
Due to promising preclinical results and favorable Phase I safety
results, VIMRX initiated a Phase II clinical trial to evaluate the
efficacy of synthetic hypericin as a topically applied, light-
activated therapy for specific skin diseases including psoriasis,
cutaneous T-cell lymphoma and warts. The studies are being conducted
at the University of Pennsylvania Medical Center, Philadelphia, by
Alain Rook, M.D., Professor of Dermatology, to evaluate the efficacy
and tolerability of topically applied, photo-activated hypericin in
persons affected by the targeted skin diseases.
VIMRX had previously established the dose range and
photoactivation conditions required to produce a biological response
with topically applied hypericin. Further, results published in the
May 1997 PhotoChemistry and Photobiology demonstrated a substantial
increase in potency of VIMRxyn(R) to inhibit growth and reproduction
responses of malignant T-cells growing in cell culture when hypericin
is photo-activated. The data indicate that photoactivated VIMRxyn(R)
causes significant anti- growth effects on malignant lymphoid cells
isolated from the blood of people living with cutaneous T-cell
lymphoma.
II. VIMRX to Discontinue Three Other VIMRxyn(R) Research Programs
VIMRX intends to focus the VIMRxyn(R) (synthetic hypericin)
clinical research program on those diseases where synthetic hypericin
appears to have the highest probability for clinical benefit.
Consequently, VIMRX has decided to discontinue three research
programs in diseases or other areas of application where clinical
benefit at tolerable doses has not been demonstrated.
HIV: Research Shows Lack of Synergistic Effect with Approved HIV
Therapies.
A research project was initiated and completed which evaluated
potential synergy between VIMRxyn(R) and combinations of other marketed
anti-viral medications for the treatment of HIV. The data indicated
a high level of cellular toxicity by hypericin alone and no evidence
of synergy. These data, coupled with the modest anti-HIV effect seen
in a 1996 Phase I/II trial where hypericin was used as a monotherapy
to treat HIV-infected individuals, have led to a decision to
discontinue development of hypericin as an anti-HIV agent.
Blood Purification: Data Indicate Unfavorable Benefit vs. Risk
Ratio -- Damage to Red Blood Cells.
VIMRX conducted a pre-clinical program to determine whether
photoactivated hypericin could provide a safe and effective way to
inactivate viruses in packed red blood cells to be used for
transfusions in an attempt to improve the safety of the blood supply.
Although viruses such as HIV can be effectively inactivated in packed
red blood cells by appropriate combinations of hypericin plus light,
data gathered this year indicate that the red blood cells themselves
are damaged by these treatment conditions. VIMRX has consequently
decided to discontinue this program.
Hepatitis C: Data Indicate No Viral Reduction.
VIMRX conducted a Phase I/II clinical trial to determine the
antiviral effectiveness of synthetic hypericin in reducing the viral
load of patients suffering from infectious chronic hepatitis C.
Twenty patients were orally dosed with VIMRxyn(R) once daily at one of
two doses for a period of two months. The results obtained to date
provide no evidence of any reduction in the viral load of the
hepatitis C virus at either dose. Also, the dose-limiting side
effect of cutaneous phototoxicity was observed in approximately 50%
of the patients. VIMRX will discontinue the clinical development
program of VIMRxyn(R) for the treatment of chronic infectious
hepatitis C.
VIMRX Pharmaceuticals Inc.
VIMRX Pharmaceuticals Inc. (NASDAQ: VMRX.O), a biotechnology
company based in Wilmington, Delaware, is comprised of a diverse
portfolio of companies, technologies and compounds. VIMRX and Baxter
Healthcare have recently created a new cell therapies company to
treat cancer and other life-threatening diseases. Through its
majority-owned affiliate, Innovir Laboratories, Inc. (NASDAQ: INVR.O),
VIMRX is developing oligozymes which control disease-triggering flaws
in individuals' genetic chemistry for potential use as both
therapeutic agents and as pharmaceutical research tools. A
collaboration with Columbia University's Genome Center, VIMRX
Genomics Inc. is focused on the commercialization of gene
discoveries in cancer and other genetically based diseases. In
additional to VIMRxyn(R), VIMRX is developing VM201, a Factor IXa
inhibitor for selective inhibition of blood clotting to manage the
bleeding risk associated with anti-coagulation; and VM301, a
dermatological agent with wound healing potential.
The PrivateSecurities Litigation Reform Act of 1995 provides a
"safe harbor" for certain forward-looking statements. The
forward-looking statements contained in this release are subject to
certain risks and uncertainties. Actual results could differ
materially from current expectations. Among the factors which could
affect the Company's actual results and could cause results to differ
from those contained in the forward-looking statements contained
herein are the success of the Company's developmental efforts and
clinical trials, delays in receiving FDA or other regulatory
approvals and the development of competing therapies and/or
technologies by other companies.
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........................... Bob |
