By Nadine M. Hasenecz

Centocor Ortho Biotech and Provectus Pharmaceuticals among companies offering new promise for those inflicted with psoriasis.

Psoriasis is a chronic, inflammatory skin condition that doesn’t discriminate. Not only can it affect a male or female of any age or nationality, but it can also present itself anywhere on the body. And it’s common, showing up in the offices of general health practitioners as well as in those of dermatologists.

In fact, psoriasis affects more than 3 percent of the U.S. population, according to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health (NIH).

As many as 7.5 million Americans have psoriasis, says the HIH. The National Psoriasis Foundation reports that approximately 125 million people worldwide, or 2 to 3 percent of the total population, have psoriasis. It also reports that total direct and indirect health care costs of psoriasis for patients are approximately $11.25 billion annually.

On occasion, psoriasis is inadvertently discovered when a doctor is checking a patient for another ailment, according to Kevin F. Rodowicz, D.O., of North Whitehall Family Practice, which is part of Bethlehem, Pa.-based St. Luke’s Physicians Group

Characterized by patches of red, raised, scaly skin that can itch and bleed, “it usually takes on what’s called a plaquelike appearance,” says Rodowicz.

Psoriasis is a genetic disease, according to the American Academy of Dermatology. While the manner in which it is inherited is not completely understood, researchers have linked it to at least eight chromosomes.

Individuals with autoimmune disorders, such as rheumatoid arthritis—in which the immune system mistakenly attacks the body—are prone to psoriasis. When a patient has psoriasis, “we start thinking of the possibility of other autoimmune disorders,” Rodowicz says.

However, an individual can have psoriasis and not have another autoimmune disorder.

Stress can cause symptoms to flare up, or worsen. Therefore, Rodowicz says, patients can help manage symptoms by reducing stress, supporting the immune system, and obtaining adequate sleep.

Typically doctors prescribe a twice daily application of a topical corticosteroid cream to help control inflammation. “We usually start out with a moderate strength [cream] and work our way up to a high strength,” Rodowicz says. Other treatments include vitamin D analogues, calcipotriene/betamethasone propionate ointment, tazarotene, tacrolimus, pimecrolimus, salicylic acid, anthralin, and a pharmaceutical known as “coal tar.” However, new research and development from biotech drug makers has put psoriasis on the front burner with treatments that are safer, far more efficient, and easier for patients to use.

This September, the U.S. Food and Drug Administration (FDA) announced that it approved STELARA (Ustekinumab) for the treatment of adult patients at least age 18 years with four-times-a-year maintenance dosing. The new drug targets patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Currently in clinical trials is PH-10, a treatment developed by bio-tech firm Provectus Pharmaceuticals, based on PV-10, a compound of Rose Bengal (iodine). Rather than suppressing the immune system, PH-10, when exposed to sunlight, works by being absorbed into ill-affected cells.

“As a topical gel, PH-10 offers many potential advantages over available treatments for psoriasis,” says Dr. Craig Dees, Ph.D., CEO of Provectus. “In particular, because it is applied onto the skin, it works directly on the psoriasis, without the likelihood of producing adverse systemic side effects that characterize many other therapies. With all patients now enrolled, we look forward to the completion of this trial.”

While patients can sometimes be discouraged by the fact that psoriasis is a lifelong condition, says Rodowicz, “we do try to encourage them that it is a manageable disorder.”

Add the promise of new research and development by bio-med firms, and individuals with psoriasis can look to a smoother, clear-skinned future.

For more information on STELARA: visit http://www.stelarainfo.com/stelarainfo/index.html
For more information on Provectus and PH-10: visit http://www.pvct.com

Inspiration for safer cancer treatments came after young daughter’s cancer scare

By Randy Lieberman

Certain events in life can catapult a person into a life-long pursuit of a solution.

It was almost a decade ago when medical trauma changed the life of Peter Culpepper, Chief Financial Officer at Provectus Pharmaceuticals, and propelled him towards a goal he continues to pursue to this day: Find a cure for cancer.

Recent announcements from Provectus have brought excitement to the pharmaceutical world, with advancements in PV-10 testing giving a new hope to cancer patients. Provectus is currently completing its Phase 2 clinical trial of PV-10 as a therapy for metastatic melanoma and has completed Phase 1 clinical testing of PV-10 for the treatment of recurrent breast carcinoma.

“People need to realize that this hope for cancer patients is here and the more people know about it, the more they can do to help,” says Culpepper.

But this hope didn’t exist in 1999, when Culpepper’s life changed in an instant.

It was February, and Culpepper, who earned his MBA from the University of Maryland at College Park, was the Senior Director for Metromedia Affiliated Corporations. He and his five-year-old daughter, Victoria, were enjoying a swim at the public pool near their home in Stamford, Conn. when she began to shake uncontrollably.

She was rushed to the hospital, where doctors found she had a brain tumor.

In only took a matter of days, surgeons removed the nearly tennis-ball sized tumor. Following the surgery were three months of chemotherapy and another three months of radiation.

“When you’re first hit with it, it’s like somebody slaps you in the face or takes the knees from out from under you,” Culpepper said, “It’s such a personal blow and it’s even worse because it’s your own child. When that happens, all of a sudden you’re thrust into this whole different world, this health care world, and it really woke up my eyes to how really challenging cancer is.”

Though Victoria was ultimately rid of the cancer, Culpepper’s brush with the disease left him fearful of a relapse. Although he was pursuing a high-paying position elsewhere, he felt there was a void, and became active with the Make-a-Wish Foundation and the American Cancer Society.

But something just wasn’t right.

“What I liked about the Make-a-Wish foundation is that they were able to make outreach to people like me they help people deal with the problem,” Culpepper said. “But I wanted to be a part of an organization or a group of people that would try to deal with the problem or solve the problem. It’s a war, there’s so many other types of cancer.”

That’s when he heard of a chief financial officer job opening at Provectus Pharmaceuticals, which at the time was beginning to develop a cancer drug with the potential to attack tumors without the aid of chemotherapy or radiation treatment. The job paid half of what he was earning, but Culpepper didn’t hesitate.

“To me, we’re not driven by the cash, it’s good, but that alone doesn’t cut it,” Culpepper said, “You have to have something else to make a true advancement.”

In February 2004, he became Provectus’ fourth employee, with an equity stake.

Peter Culpepper, CFO of Provectus

Culpepper’s greatest chance at finding a cure may be upon us quicker than most thought.

The compassionate-use program, which is in development as a therapeutic drug for a broad spectrum of cancers, was recently made available for select cancer patients.

“PV-10 as a treatment is very unique,” Culpepper said. “One, it stands alone, it doesn’t use other chemotherapy agents; Two, it’s extremely safe, which is very unusual for cancer drugs; And three, it triggers the immune system so the immune system goes out and kills the cancer directly.”

Those three things, the safety, efficacy and the immediate response, have never been seen in one drug before, Culpepper said. It also isn’t limited to one type of tumor; it is effective on nine major cell tumors, according to Culpepper, which include melanoma, breast cancer, liver cancer and pancreatic cancer.

“Pharmaceutical research has shown that it’s very rare to get a compound and have it go through to get processed,” Culpepper said, “They say one out of 15,000, or there are some huge odds, plus it’s terrifically expensive.”

But the persistence of the company has led to the breakthrough.

“It just shows how tough cancer is,” Culpepper said. “Cancer is very challenging.”

The development-stage oncology and dermatology bio-pharmaceutical company, Provectus will initially make the compassionate use program available for cancer indications that do not involve visceral organs and are not subject to enrollment in ongoing clinical trials. These indications include certain breast cancers, basal cell carcinoma, squamous cell carcinoma, certain head and neck cancers and melanoma.

PV-10 is a form of Rose Bengal that is injected directly into a tumor, and according to Dr. Agarwala, Principal Investigator for Provectus’ Phase 2 PV-10 trial site at St. Luke’s Hospital & Health Network in Bethlehem, PA, has shown a 60 percent efficacy rate with little, or no side effects.

Provectus has begun its compassionate program for PV-10 in certain Australian “Centers of Excellence,” including Sydney, Brisbane and Adelaide, and will expand it to the United States in coming months. The Australian program is under the guidelines of the Therapeutic Goods Administration’s Special Access Scheme.

“People are going to be very interested in how far PV-10 develops and how good it is,” Culpepper said, “It could be the first true breakthrough cancer treatment where everyone wants a stand-alone agent that treats multiple cancer patients.”

As for the now 16-year old Victoria, Culpepper’s daughter, she has been cancer free since the treatment. “The doctors say the longer the time goes by, the better off the chance are that it won’t come back,” Culpepper said. “But right around now we’re on pins and needles because every year around this time we go through the MRI’s just to make sure it’s not re-growing in her brain.”

The most important thing for Culpepper now is making the world aware of the breakthrough drug that Provectus hangs its hat on.

“We want the world to know about PV-10 because it needs to have the light of day,” Culpepper says.

Dear Shareholders:

I am pleased to report that 2009 has already been a year of continued progress and excitement for Provectus. Our clinical trials for both PV-10 and PH-10 have shown promising results. We have completed patient accrual in two of our ongoing Phase 2 trials—PV-10 for metastatic melanoma and PH-10 for atopic dermatitis.

We believe the results show that PV-10 can be a viable treatment for metastatic melanoma, and we are focusing our efforts on completing the 80 patient study, while also making plans for our next steps in development. Those next steps include seeking licensure agreements and/or partnerships to proceed through final development, and ultimately, bringing the product to market. In addition, we intend to meet with the FDA to determine exactly what steps we need to take to obtain approval of PV-10 for metastatic melanoma.

Compelling data was presented at the American Society of Clinical Oncology (ASCO) meeting in May/June 2009. Interim data from the first 40 subjects in our Phase 2 clinical trial for the treatment of metastatic melanoma demonstrated an objective response (i.e. meaningful response) in 60% of subjects, with 75% of subjects achieving locoregional disease control of their treated lesions. Just over half (52%) of subjects had one or more evaluable untreated bystander lesions, and 48% of these subjects exhibited an objective response in those lesions. This bystander response was strongly correlated with successful destruction of the subject’s PV-10 injected lesions, with 69% of these bystander responses occurring among subjects whose injected lesions responded to PV-10.

Researchers concluded that PV-10 is well-tolerated, eliciting a robust response in a majority of patients. The safety and efficacy profile compare favorably with existing and emerging therapies, making PV-10 suitable for repeat treatment of patients with partially-responsive lesions or new lesions to maximize response and long-term outcome.

What does this mean? These interim data demonstrate that PV-10, injected directly into melanoma tumors, can selectively kill the cancerous tumor tissue, and may also stimulate the patient’s immune system to destroy untreated tumors elsewhere in the body. Continue reading the entire article at Provectus’ website.

Provectus Trials Show Promise

Does Provectus have a cure for Cancer?

The Report, a highly acclaimed ABC current affairs program airing in Australia, recently ran a story on the treatment of melanoma with PV-10.

It looks very promising; you determine for yourself, and provide comments and feedback.

Launch of Compassionate-Use Drug Opens New Avenue in Fight Against Cancer

By Randy Lieberman

If there was any hope for finding a cure for cancer, this may be it.

Cancer takes more than 600,000 lives in the United States each year, according to National Cancer Institute.

A new ray of hope to these victims is the announcement that Provectus Pharmaceuticals Inc. has begun a compassionate use program for PV-10 and has made the agent, which is in development as a therapeutic drug for a broad spectrum of cancers, available for select cancer patients.

The development-stage oncology and dermatology bio-pharmaceutical company, Provectus will initially make the compassionate use program available for cancer indications that do not involve visceral organs and are not subject to enrollment in ongoing clinical trials. These indications include certain breast cancers, basal cell carcinoma, squamous cell carcinoma, certain head and neck cancers and melanoma.

PV-10 is a form of Rose Bengal that is injected directly into a tumor, and according to Dr. Agarwala, Principal Investigator for Provectus’ Phase 2 PV-10 trial site at St. Luke’s Hospital & Health Network in Bethlehem, PA, has shown a 60 percent efficacy rate with little, or no side effects.

Provectus has begun its compassionate program for PV-10 in certain Australian “Centers of Excellence,” including Sydney, Brisbane and Adelaide, and will expand it to the United States in coming months. The Australian program is under the guidelines of the Therapeutic Goods Administration’s Special Access Scheme.

The U.S. program on the other hand is expected to be under the FDA’s regulations covering Treatment Use of an investigational new drug. Compassionate use programs provide experimental therapeutics to patients prior to final FDA approval.

Provectus received orphan drug designation from the FDA for its melanoma indication in early January of 2007. Complementing their suite of proprietary drugs, Provectus has developed a number of intellectual properties and technologies in the areas of imaging, medical devices and biotechnology.

Dr. Kelly McMasters, a preeminent physician and investigator who is a member of Provectus’ Board of Directors and head of its Scientific Advisory Board, will advise the Company on candidates for the program who might be safely helped by PV-10.

McMasters said, “The potential for PV-10 to successfully treat metastatic melanoma, which has already been shown in humans, warrants its further use for melanoma and for other life-threatening scenarios on a compassionate use basis.”

Provectus is currently completing its Phase 2 clinical trial of PV-10 as a therapy for metastatic melanoma and has completed Phase 1 clinical testing of PV-10 for the treatment of recurrent breast carcinoma.

“We decided to initiate this program as we have had a continuing large number of requests by physicians and patients to make PV-10 available on a compassionate basis,” said Craig Dees, Ph.D., CEO of Provectus.

“Preliminary analysis of interim Phase 2 results from our melanoma clinical trial suggests that we can safely provide PV-10 for treatment of selected cancer patients, and that the agent has potential to benefit some of these patients. Knowing this information, we believe the ethical choice is to make the drug available on a compassionate use basis.”

Information about these and the Company’s other clinical trials can be found at the NIH registry, www.clinicaltrials.gov.

Interested parties are encouraged to visit Provectus’ website, www.pvct.com, where details on the compassionate use program and additional information will be posted in the near future.

KNOXVILLE, TN (June 1, 2009) /PRNewswire/ — Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, has announced interim data from the first 40 subjects in its Phase 2 clinical trial for the treatment of metastatic melanoma. PV-10 treatment was well tolerated and caused selective tumor destruction in the majority of subjects. Additional data on untreated tumors corroborated observations of a possible bystander effect seen during earlier Phase 1 testing. These data were presented today at the American Society of Clinical Oncology 2009 Annual Meeting, Abstract #9060, entitled “Chemoablation of melanoma with intralesional rose bengal (PV-10),” in the General Poster Session.

Key interim data from the first 40 subjects in the Phase 2 study included:

• Objective response of PV-10 treated lesions was observed in 60% of subjects.
• Locoregional disease control of treated lesions was observed in 75% of subjects.
• Response of untreated bystander lesions was consistent with observations from Phase 1 testing.
• Interim safety data were comparable to Phase 1, with transient mild to moderate locoregional pain, vesicles, edema or swelling most common.

“These data provide us much encouragement as they continue to demonstrate how potentially safe and effective PV-10 is for the treatment of metastatic melanoma,” said Dr. Sanjiv Agarwala, Principal Investigator for Provectus’ Phase 2 PV-10 trial site at St. Luke’s Hospital & Health Network in Bethlehem, PA, who presented the abstract at ASCO. “Particularly positive is further evidence of the ‘bystander effect,’ which appears to induce the patient’s immune system to attack and shrink untreated tumors. Because melanoma often metastasizes in areas of the body that are difficult to treat, such as the head and neck, the ‘bystander effect’ could dramatically improve the prognosis for many patients. We are excited about these results and look forward to continued development of this therapy.”

Dr. Craig Dees, PhD, Chairman and Chief Executive Officer of Provectus said, “The progress we are making in the clinical trials of PV-10 helps pave the way for its possible future as a safe and effective therapy for metastatic melanoma patients. The results presented from the first 40 subjects in the Phase 2 trial bring us another step closer to helping the many thousands of individuals afflicted each year with this insidious disease, whose incidence is rising faster than any other cancer in the U.S. today.”

The American Cancer Society estimates that there are 120,000 patients in the United States with Stage III or Stage IV melanoma, and that 68,000 new cases will be reported in 2009. The World Health Organization reported that it expected 48,000 global deaths in 2008 alone from Stage III or Stage IV melanoma.

Key interim data from the first 40 subjects in the Phase 2 study included:

– Objective response of PV-10 treated lesions was observed in 60% of subjects.

– Locoregional disease control of treated lesions was observed in 75% of subjects.

– Response of untreated bystander lesions was consistent with observations from Phase 1 testing.

– Interim safety data were comparable to Phase 1, with transient mild to moderate locoregional pain, vesicles, edema or swelling most common.

“These data provide us much encouragement as they continue to demonstrate how potentially safe and effective PV-10 is for the treatment of metastatic melanoma,” said Dr. Sanjiv Agarwala, Principal Investigator for Provectus’ Phase 2 PV-10 trial site at St. Luke’s Hospital & Health Network in Bethlehem, PA, who presented the abstract at ASCO. “Particularly positive is further evidence of the ‘bystander effect,’ which appears to induce the patient’s immune system to attack and shrink untreated tumors. Because melanoma often metastasizes in areas of the body that are difficult to treat, such as the head and neck, the ‘bystander effect’ could dramatically improve the prognosis for many patients. We are excited about these results and look forward to continued development of this therapy.”

Dr. Craig Dees, PhD, Chairman and Chief Executive Officer of Provectus said, “The progress we are making in the clinical trials of PV-10 helps pave the way for its possible future as a safe and effective therapy for metastatic melanoma patients. The results presented from the first 40 subjects in the Phase 2 trial bring us another step closer to helping the many thousands of individuals afflicted each year with this insidious disease, whose incidence is rising faster than any other cancer in the U.S. today.”

The American Cancer Society estimates that there are 120,000 patients in the United States with Stage III or Stage IV melanoma, and that 68,000 new cases will be reported in 2009. The World Health Organization reported that it expected 48,000 global deaths in 2008 alone from Stage III or Stage IV melanoma.

Dr. Agarwala added, “Advanced melanoma is an extremely difficult disease to treat, even with the approved chemotherapy or immunotherapy drugs that exist. In the last decade there have not been any new drugs approved for melanoma, which demonstrates how resistant this devastating disease is to the traditional methods of treatment. That is one of the many reasons that I find these newly published data very important and am encouraged by their implications.”

Background and Summary of the Data Presented at ASCO (Abstract # 9060):

Expanded Phase 2 testing of PV-10 commenced in late 2007 in 80 subjects with Stage III or IV melanoma, and enrollment was completed in May 2009. Enrollment for this multi-center study was conducted at seven sites in Australia and the United States. Thirty five subjects with Stage III disease and five with Stage IV disease comprised the cohort analyzed, with a median of 8 lesions treated per subject over 2 treatment cycles. The reported safety and efficacy data demonstrate that therapy with PV-10 compares favorably with available therapeutic options for this patient population.

PV-10 treatment was generally well tolerated, with most adverse effects transient, locoregional and mild to moderate in severity. Locoregional pain (reported by 60% of subjects), vesicles (30%), edema (28%) or swelling (18%) were most common. Severe (Grade 3) adverse effects were relatively rare (1 case each of vesicles, cellulitis and skin flap necrosis and 2 cases of severe pain), with no Grade 4 or 5 adverse effects attributed to PV-10. These results were comparable to observations from Phase 1 testing of PV-10.

Interim efficacy data for the first 40 subjects were also comparable to that of Phase 1, with 30% of subjects achieving a Complete Response (CR), and an additional 30% of subjects achieving a Partial Response (PR) in their treated lesions during the first 24 weeks following initial PV-10 treatment, for an Objective Response (OR) of 60%; Stable Disease (SD) was achieved by 15% of subjects, while 25% experienced Progressive Disease (PD), equating to a 75% rate of locoregional disease control of treated lesions. Just over half (52%) of subjects had one or more evaluable untreated bystander lesion, and 48% of these subjects exhibited an improvement in their bystander lesions qualifying as a CR (24%) or PR (24%); an additional 14% achieved SD in these lesions, for a 62% rate of locoregional disease control of bystander lesions. As previously reported for Phase 1 testing, this apparent bystander effect was strongly correlated with successful ablation of the subject’s PV-10 injected lesions, with a majority of bystander responses qualifying as a CR or PR (OR = 69%) among those subjects that achieved an OR of their injected lesions. In contrast, subjects that did not achieve an OR in their injected lesions experienced minimal benefit (12% OR) in their non-injected bystander lesions.

In addition to these Phase 2 results, extended survival data were reported from the Phase 1 study, showing a survival advantage in terms of both overall survival (median 42.1 months vs. 12.3 months) and disease specific survival (44.1 months vs. 14.6 months) for subjects that achieved an OR in the Phase 1 study versus those that did not respond so robustly to PV-10. Such data support a possible systemic benefit for PV-10.

About PV-10

PV-10 is a proprietary, injectable formulation of Rose Bengal, a compound that has been in use for nearly thirty years by ophthalmologists and optometrists to assess damage to the eye. It has also been used to detect ailments of the liver. Rose Bengal has an established safety history, a short half-life in the bloodstream, and is excreted via the liver and kidneys. Provectus has discovered a novel use for Rose Bengal based on the observation that it is selectively toxic to cancer calls via a process called chemoablation whereby cells undergo a form of cell death that mimics both features of necrosis and apoptosis.

About Provectus Pharmaceuticals, Inc.

Provectus Pharmaceuticals is a development stage company that specializes in oncology and dermatology therapies that are safer, more effective, less invasive and more economical than conventional therapies. Provectus is currently conducting Phase 2 clinical trials of its proprietary drugs PV-10 as a therapy for metastatic melanoma and PH-10 as a topical treatment for psoriasis and atopic dermatitis. Information about these and the Company’s other clinical trials can be found at the NIH registry, http://www.clinicaltrials.gov. The Company has received orphan drug designation from the FDA for its melanoma indication. Complementing their suite of proprietary drugs, Provectus has developed a number of intellectual properties and technologies in the areas of imaging, medical devices and biotechnology.