|
We
are pleased you are visiting our Provectus Pharmaceuticals
Web site. As you will see, our company is engaged in
exciting research & development activities. This
site is intended to provide a useful introduction into
the innovative world of Provectus.
We are a group of dedicated and entrepreneurial
scientists and business people, working together for the past 12 years,
engaged in developing breakthrough technologies for
cancer and other serious diseases. Our primary goal
at Provectus is to develop alternative treatments that
are safer, more effective, less invasive and more economical
than conventional therapies.
Provectus develops ethical
pharmaceuticals for oncology and dermatology. Looking
first to oncology, our novel drugs are designed to selectively
target and destroy cancer cells without harming surrounding
healthy tissue, significantly reducing systemic side
effects. In particular, our focus is on melanoma, breast
and liver cancers – among the most difficult
cancers to treat using conventional methods.
With our dermatology Phase 2 trials completed, the melanoma Phase 2 trial nearly completed, two expanded access ("compassionate use")
programs in place and a key Phase 1 trial underway (assessing PV-10 for use against cancers of the liver), there is a lot to be excited
about, on both the clinical development and corporate fronts.
One of the highlights of 2009 was the presentation of interim data from our Phase 2 study of PV-10 for metastatic melanoma at the 2009 American Society of
Clinical Oncology (ASCO) Scientific Program in May and June, by Dr. Sanjiv S. Agarwala, Principal Investigator from the PV-10 trial's site at St. Luke's
Hospital & Health Network in Bethlehem, PA. The abstract, entitled "Chemoablation of melanoma with intralesional rose bengal (PV-10)", reported that for
the first 40 subjects, a 60% objective response rate was achieved with a 75% rate of loco-regional control of treated lesions. As observed in our previous
Phase 1 study, a substantial number of these subjects exhibited evidence of a bystander effect, where it appears that PV-10 ablation induces the subject's immune
system to fight untreated tumors elsewhere in the body.
At the 3rd World Meeting of Interdisciplinary Melanoma/Skin Cancer Centers in Berlin, Professor John F. Thompson, MD, Professor of Melanoma and Surgical Oncology
at the University of Sydney, Director of the Melanoma Institute Australia, and Lead Investigator of the Phase 2 study, reported that initial one year overall
survival data from the first 20 subjects in the current Phase 2 trial showed comparable trends to those of the Phase 1 trial, where markedly longer overall and
disease specific survival were observed for subjects that were responsive to PV-10 relative to those who did not experience a robust response.
Based upon requests from physicians, we initiated two expanded access programs ("compassionate use”) for PV-10 in Australia and the U.S. These are active
at five of our Phase 2 study centers. As of the end of 2009, a total of 20 melanoma patients, 8 of whom have crossed over from the Phase 2 study to receive further treatment, have
commenced treatment with PV-10 under the program. A majority of these patients are in long-term follow-up for up to two years.
Targeting abnormal or diseased cells is also the
approach we use in designing proprietary treatments
for dermatological diseases, in particular, chronic,
severe cases of psoriasis and atopic dermatitis (including atopic eczema). Positive preliminary results from
our Phase 2 studies of PH-10 in psoriasis and atopic dermatitis were announced in 2009, illustrating the drug's potential effectiveness as a treatment for serious
dermatological diseases and providing compelling data to attract licensure agreements. For psoriasis, preliminary data show that 79% of 29 subjects in the
trial demonstrated improvement in the Psoriasis Severity Index (PSI) during four weeks of daily treatment with PH-10. In addition, 83% of subjects reported no
or only mild pruritus (itching) by week four of the trial. For atopic dermatitis ("eczema"), preliminary data from the first 18 subjects indicated that 94%
had improvement in Eczema Area Severity Index (EASI) scores during four weeks of treatment. In both studies the treatments were generally well tolerated with
no significant safety issues identified.
We are proud of our intellectual capital at Provectus.
We hold a growing number of U.S. patents in the pharmaceutical, medical
device and biotech fields, with many additional patent
applications in the works in the U.S. and internationally.
Provectus is a significant, emerging player in
the huge and growing pharmaceutical industry. We believe
in our potential to improve health care worldwide using
breakthrough products that are easy to manufacture and
license, and economical to use. We appreciate your interest
in our company, and welcome your comments and questions.
Craig Dees, Ph.D., CEO
Provectus Pharmaceuticals
|