Category Archives: Provectus Pharmaceuticals Inc. PVCT

Provectus Pharmaceuticals Inc. (PVCT.OB) Delivers Favorable Oncology Treatment; Presents Data to 3rd World Meeting of Interdisciplinary Melanoma/Skin Cancer Centers

November 24, 2009

Provectus Pharmaceuticals Inc. is a development-stage biopharmaceutical study focused on oncology and dermatology therapies. The company recently announced that the results of its phase II trial showed comparable trends to phase I survival data for 20 subjects with metastatic melanoma.

The one-year overall survival data of its lead oncology agent PV-10 showed longer overall and disease specific survival for subjects that were responsive to the agent, relative to those who did not experience a robust response. In addition, several subjects experienced spontaneous regression of untreated tumors after PV-10 treatment of other tumors.

The company also announced that 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 II study of PV-10 for Metastatic Melanoma, recently presented the study results at the 3rd World Meeting of Interdisciplinary Melanoma/Skin Cancer Centers in Berlin, Germany.

“We are very excited by these new results presented by Professor Thompson, especially the first reported objective evidence of potential systemic benefit in visceral organs. We look forward to the possibility of augmenting these results with data from the next 20 subjects, which we expect will be available in the first quarter of 2010. Progress with our expanded access program for PV-10, the means through which certain qualified patients can receive PV-10 on a compassionate use basis, is also heartening as we continue development of the agent toward licensure,” Craig Dees, PhD, CEO of Provectus stated in the press release.

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Provectus Pharmaceuticals Inc. (PVCT.OB) Adds Second Site for Phase 2 Clinical Study of PH-10 for Psoriasis

August 18, 2009

Provectus Pharmaceuticals Inc. is quickly gaining a reputation as an up-and-coming development-stage oncology and dermatology biopharmaceutical company. Helping to enhance this reputation and its position in the marketplace, Provectus announced the addition of Mount Sinai School of Medicine as the second and final site for its expanded Phase 2 clinical trial of the company’s lead dermatology agent PH-10 for psoriasis. Jason Elmer, M.D., who served as the lead investigator for the Phase 2 clinical trial of PH-10 for atopic dermatitis of which patent enrollment was completed in June, will also serve as the principal investigator of this trial.

Commenting on the value of Dr. Elmer’s work on this project, Provectus CEO Craig Dees, Ph.D. stated, “Dr. Emer’s work with PH-10 for atopic dermatitis, his involvement in the ongoing research of the product as a dermatological therapy, and Mount Sinai School of Medicine’s outstanding reputation in dermatological research make this center an outstanding choice for the second and final site of our ongoing Phase 2 trial for psoriasis.”

Enrollment in the Phase 2 trial for psoriasis in expected to consist of 30 subjects and commenced in July of this year. Enrollment is non-randomized with the purpose of measuring safety and efficiency of PH-10. PH-10 is an aqueous hydrogel formulation of rose bengal disodium for topical administration to the skin, and is being studied for the treatment of cutaneous skin disorders, specifically psoriasis and atopic dermatitis. The estimated primary completion date for final data collection is February 2010, with the study estimated to be completed by April 2010. Patients interested in participating in the trial may find further information at the NIH clinical trials registry, www.clinicaltrials.gov or at www.pvct.com.

Statistics show there is a major need for this new development. According to the National Institutes of Health, as many as 7.5 million Americans, approximately 2.2 percent of the U.S. population, have psoriasis. The National Psoriasis Foundation reports that approximately 125 million people worldwide, 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.

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Provectus Pharmaceuticals, Inc. (PVCT.OB) Reports Results of Shareholders Meeting

June 19, 2009

Yesterday, Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, held its 2009 Annual Meeting of Shareholders in Knoxville, Tennessee. During the meeting, shareholders voted to re-elect the company’s five members of the Board of Directors, which is composed of three inside directors, and two outside directors. Each Director serves a one-year term.

Dr. Dees, CEO of Provectus commented, “We appreciate the confidence of our shareholders as Provectus continues to achieve its milestones for the development of PV-10 and PH-10. Our recently reported ASCO data support our mission to continue our quest to find a viable, safe and effective treatment for metastatic melanoma, and further our research towards that end. Having completed patient accrual in May for our phase 2 melanoma trial, we look forward to communicating additional results to the scientific community and investors in coming months.”

Dr. Dees continued, “While our primary focus has been directed towards gaining regulatory approval for PV-10 in metastatic melanoma, data from oncology tests in animals indicates the drug has broad spectrum activity towards numerous tumor types. Further, to our knowledge PV-10 is the only intralesionally delivered agent that has been repeatedly demonstrated to induce removal of remote, untreated tumors through a bystander effect.”

Dr. Dees concluded, “While our focus has been on developing PV-10 for metastatic melanoma, our scientific team and investigators are also working on developing PV-10 for other primary and metastatic cancers, such as those of the liver, as well as on PH-10 for atopic dermatitis and psoriasis, both of which are in Phase 2 trials. We look forward to furthering these important studies as well in the upcoming year.”

Provectus also announced that it has updated its website, providing investors and the scientific community with an easy-to-navigate portal to get up-to-date information on the company and its clinical trials. The improved and highly-functional website enables the public to get information they need on Provectus and its development pipeline.

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Provectus Pharmaceuticals, Inc. (PVCT.OB) Introduces New Center as Phase 2 Begins for Leading Oncology Agent

November 2, 2008

Provectus Pharmaceuticals, Inc. (OTC BB: PVCT) announced that they have commenced recruitment for their Phase 2 clinical trial of the company’s lead oncology agent PV-10 at a fifth major center, now covering the northeastern United States. The new center joins the other company’s centers located in Sydney, Brisbane and Adelaide, Australia, and Houston, Texas.

Sanjiv Agarwala, M.D. has been appointed as the principal investigator at the new center, located at St. Luke’s Hospital & Health Network, in Bethlehem, PA. Over the next several months, the company intends to continue expansion of the study to include sites in other major population centers in Australia as well as several sites in the United States.

Phase 2 clinical testing of PV-10 is designed to assess the agent as a treatment for Stage III and IV metastatic melanoma, the most aggressive and deadly form of skin cancer. The multi-center study will evaluate efficacy of PV-10 in a total of 80 subjects. Within the study, PV-10 will be injected into up to 20 tumors in each subject. Additional treatment with PV-10 may be made 8 to 16 weeks after this initial injection, if deemed necessary by the investigator. Response will be observed for one year, allowing data to be gathered for assessment of objective response rate, progression free survival, quality of life and safety.

“This clinical trial represents a promising option for patients with advanced melanoma that have tumors amenable for direct injection,” stated Dr. Agarwala, Section Chief, Hematology/Oncology for St. Luke’s.

“Opening the center at St. Luke’s is a logical continuation of our expansion of our Phase 2 program in melanoma to multiple sites including the U.S.,” stated Craig Dees, Ph.D., CEO of Provectus. “It is another important step in our effort to get the treatment available to as many patients as possible in the shortest possible time.”

Provectus recently announced that enrollment is nearing the halfway point in the study. Further updates on the study are planned for the Clinical Oncology Society of Australia (COSA) meeting to be held on November 19, in Sydney, Australia. Professor John F. Thompson, M.D., will providing a thorough review of Phase 1 results and interim safety data from the first 20 subjects in the Phase 2 study.

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Provectus Pharmaceuticals, Inc. (PVCT.OB) Chairman Will Present, Host Community Events

October 21, 2008

Provectus Chairman and CEO, Craig Dees, Ph.D, first hosts a luncheon on Oct. 29, starting at Noon at the Hyatt Regency (151 E. Wacker Drive) in Chicago, Ill. Dees will then present twice in New York City. The first will be at the Wall Street Analyst Forum, from Nov. 17-19 at the University Club, 1 W 54th St. He will then present at the 12th Annual New York Society of Security Analysts (NYSSA) Biotechnology/ Specialty Pharmaceutical Industry Conference, Dec. 2-3 (location TBA).

“As Provectus continues to make significant strides in developing our oncological and dermatological therapies, we continue to strive to increase investor awareness and visibility of the company,” Dees said.

Dees has spent more than 20 years in senior management positions at Provectus Pharmaceuticals, Inc.; Photogen Technologies, Inc.; the Oak Ridge National Laboratory; LipoGen, Inc.; and TechAmerica, Inc. Dees was a founder, senior scientist and founding director of Photogen before Provectus was formed. His responsibilities have included product design and development in the fields of ethical vaccines, cosmetics, human diagnostics and over-the-counter pharmaceuticals.

Provectus is a development-stage oncology and dermatology biopharmaceutical company. It has two drugs currently undergoing clinical trial; “PV-10″ as a therapy for metastatic melanoma and “PH-10″ as a topical treatment for psoriasis and atopic dermatitis. To complement drug development, the company has also originated a number of intellectual properties and technologies in the areas of imaging, medical devices and biotechnology.

In his presentations, Dees will discuss progress in PV-10. Interim reports of test subjects in its phase 2 clinical trial shows that PV-10 is well-tolerated with no unexpected side effects.

“In addition, long-term survival data for subjects participating in the phase 1 trial suggests that the response of treated lesions may be a good predictor of long-term outcome,” Dees said.

The company reports that In Phase 1, 40% of subjects achieved an objective response in their treated lesions by having them shrink or disappear, and 75% achieved loco-regional disease control where the lesions at least stopped growing.

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Provectus Pharmaceuticals, Inc. (PVCT.OB) Curing Cancer in Upcoming Peer-Reviewed Melanoma Research Paper

October 14, 2008

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. The announcement of a peer-reviewed paper entitled “Chemoablation of metastatic melanoma using intralesional Rose Bengal,” which can be found on the Provectus website, will soon be published in the December issue of “Melanoma Research.”

Our Director of Marketing had the great fortune to see Provectus Pharmaceuticals up close and in person during a recent conference and sat aghast as they unveiled cancer after cancer being treated and then cured by their PV-10 drug. If you have a moment to take a look at the clinical photos of the melanoma research, we highly recommend it. The paper presents the clinical data for the first 11 subjects in Phase 1 trial.

According to the paper, twenty-six target lesions were injected with PV-10, and an additional 28 lesions were observed without treatment to assess the bystander effect. The bystander effect of PV-10 was incredible, curing 90% of the remaining melanomas.

The authors note, “The treatment was well tolerated and an objective response was observed in 12 target lesions, with an additional seven lesions remaining static over at least 12 weeks of observation. In this dose-evaluation study, response rate was dose dependent, increasing to 69% after higher dose injections. Nontarget lesions exhibited a 27% objective response rate that increased to 44% in patients exhibiting a positive response of target lesions. These findings indicate that intralesional Rose Bengal is nontoxic and could benefit patients with metastatic melanoma.”

Provectus is currently conducting Phase 2 clinical trials of their proprietary drugs; PV-10 as a therapy for metastatic melanoma and PH-10 as a topical treatment for psoriasis and atopic dermatitis. The Company has received orphan drug designation from the FDA for its melanoma indication, which in essence, fast-tracks the drug through the FDA.

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Provectus Pharmaceuticals Inc. (PVCT.OB) Will Present at the Wall Street Analyst Conference

September 9, 2008

Provectus Pharmaceuticals Inc. (PVCT.OB) is a company that specializes in oncology and dermatology therapies that are safer, more effective, less invasive, and more economical than conventional therapies. The company has also developed a number of intellectual properties and technologies in the areas of imaging, medical devices, and biotechnology.

Provectus is currently conducting Phase 2 clinical trials of their proprietary drugs — PV-10 as a therapy for metastatic melanoma and PH-10 as a topical treatment for moderate to severe psoriasis and atopic dermatitis. The company has received orphan drug designation from the FDA for PV-10.

Provectus announced that on September 10th, 2008, CEO Craig Dees, Ph.D. will present at the Wall Street Analyst Forum’s 19th Annual Analyst Conference. Mr. Dees will review the results of the Phase 1 clinical trial Provectus has completed in melanoma patients. In this study, individual tumors were injected with PV-10, and in many cases the tumors began dying within 7 days and lifted off the skin within 14 days.

In the Phase 2 trials of this drug, the first 20 of 80 patients have been treated with PV-10. The trial is being conducted by renowned oncology researcher, Professor John F. Thompson, M.D., who is director of the Sydney Melanoma Unit at the University of Sydney, Australia.

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Positive Phase 2 Clinical Trial for Provectus Pharmaceuticals Inc. (PVCT.OB) Drug

July 7, 2008

Provectus Pharmaceuticals Inc. (PVCT.OB) is a Tennessee-based development stage pharmaceutical company that specializes in oncology and dermatology therapies. Complementing the company’s lineup of proprietary drugs, Provectus has developed a number of intellectual properties and technologies in the areas of imaging, medical devices, and biotechnology.

In the biotechnology area, the company has developed groundbreaking technology to augment vaccine production and detect viruses. Another area that Provectus is focusing on is the dermatology space. The company is currently conducting Phase 2 clinical trials of their proprietary drug PH-10, to be used as a topical treatment for psoriasis and atopic dermatitis.

Provectus Pharma’s main focus however is in the treatment of cancer. The company is developing advanced therapies to target and destroy the deadliest cancers – melanoma, liver cancer, and breast cancer – while eliminating side effects. Clinical trials for treatment of metastatic melanoma and recurrent breast carcinoma with the company’s PV-10 drug are currently underway in Australia.

On July 7, 2008, Provectus announced that the first 25% of melanoma subjects in Australia have been treated in the company’s Phase 2 clinical trial of PV-10. If the results from these Phase 2 trials are as positive as the results were from the Phase 1 trial, the company expects to then ask the FDA for an accelerated approval. Provectus also expects to begin Phase 2 trials for PV-10 in the U.S. in the very near future.

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Provectus Pharmaceuticals, Inc. (PVCT.OB) Rated Market Perform Rating

November 28, 2007

Rodman & Renshaw, LLC, a leading investment bank, initiated research coverage of Provectus Pharmaceuticals, Inc. (PVCT) by granting the company a Market Perform Rating.

Provectus Pharmaceuticals, a leading Pharmaceutical company, specializes in developing oncology and dermatology therapies that are safer, more effective, and less invasive than current therapies. Currently, Provectus is conducting Phase 2 clinical trials of two of their proprietary drugs, PV-10 and PH-10. PV-10 is used as to treat melanoma and breast cancer, and PH-10 as a topical treatment for moderate to severe psoriasis. The Company has already received orphan drug designation from the FDA for metastatic melanoma.

Rodman & Renshaw is a full service investment bank, dedicating in providing investment banking services to companies with recurring capital needs. Rodman & Renshaw is focused on research, sales, and trading services to institutional investor clients that focus on such companies. Through Renshaw’s AcumenBioFin division, Rodman provides advantageous investment banking services for biotechnology companies, as well as PIPE (private investment in public equity) transactions.

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Provectus Pharmaceuticals, Inc. (PVCT.OB) Treats First Patient with Topical PH-10 at Mount Sinai School of Medicine

November 27, 2007

Provectus announced today that it has begun treating its first patient and is recruiting patients for the Phase 2 clinical trial of topical PH-10, which is designed to treat psoriasis.

The study will assess the effectiveness of topically applied PH-10 in twenty-five participants. The medication will be administered twice a week for up to twelve weeks. The entire study is taking place at the Mount Sinai School of Medicine in New York and is anticipated to take nine months to complete.

Craig Dees, Ph.D., CEO of Provectus, stated, “We are pleased to offer patients with moderate to severe psoriasis the opportunity to participate in the Phase 2 clinical trial of PH-10, which we hope will prove to be more efficacious and safer than currently existing products,”

He continued to say, “If the study proves to be as successful as we expect, topical PH-10 could be extremely advantageous in the treatment of psoriasis, a large underserved market in which current, highly expensive treatments may be efficacious but have a number of side effects including infections and risk of cancer.”

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Provectus Pharmaceuticals, Inc. (PVCT.OB) Commences Phase 2 Clinical Trial

November 13, 2007

Provectus Pharmaceuticals announced today that it has received approval to begin Phase 2 clinical testing of PH-10, the company’s topical drug designed to treat psoriasis. The study is intended to identify the effectiveness of PH-10 by using twenty-five subjects with moderate to severe forms of the disease.

PH-10 will be applied twice weekly for up to twelve weeks to each participant’s psoriatic plaque areas. The reaction will be monitored throughout this treatment phase and a month after the end of the phase. Response will be graded using the Psoriasis Severity Index (PSI) and an investigator’s clinical assessment of Plaque Response. Changes in itching, time-to-response, and preliminary assessment of durability of response will also be assessed, together with comprehensive safety monitoring.

Craig Dees, PhD, Chief Executive Officer of Provectus, stated, “Building on the results from our Phase 1 program, which looked at safety and preliminary efficacy of several formulations of PH-10, we are pleased to begin this Phase 2 study in psoriasis. In addition to this study, we expect to soon begin clinical study of PH-10 for atopic dermatitis (eczema), and are continuing pre-clinical studies of PH-10 for treatment of infectious diseases of the skin, focused on antibiotic resistant Staphylococcus aureus (MRSA), which is a growing public health concern.”

Dr. Dees continued, “Topical PH-10 may be advantageous in psoriasis, eczema, and other indications in dermatology that are largely underserved markets characterized by expensive products that often carry a number of extremely undesirable side-effects, including local or systemic infection and in some cases can result in cancer. We are optimistic that PH-10 can improve the opportunities available to a large number of these patients.”

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Provectus Pharmaceuticals, Inc. (PVCT.OB) is “One to Watch”

November 5, 2007

Provectus Pharmaceuticals is focused on developing advanced therapies designed to target and destroy the deadliest cancer as well as developing groundbreaking biotechnologies to augment vaccine production and detect viruses. The company is currently conducting clinical trials on their two proprietary drugs, Provecta and Xantryl.

Provectra is unique from other cancer treatments by concentrating on toxic levels of tissue while avoiding healthy tissue consequently making it safer and more effective than conventional therapies such as chemotherapy and radiation. The drug is targeting melanoma and focal tumors of the breast, liver and prostate, which together account for more than 520,000 new cases in the United States each year and are among the most difficult cancers to treat using conventional therapies.

Xantryl is primarily focused on treating psoriasis. Current treatments for the disease carry disadvantages such as potentially developing skin cancer, suppressing the immune system, and requiring repeated injections. Xantryl separates itself from these disadvantages by specifically targeting only diseased tissue and confining the effects of light activation to only areas of skin affected by psoriasis.

In addition to its core pharmaceutical work, the company has also developed a number of intellectual properties and technologies in the fields of medical devices and biotechnologies. Provectus has shown itself to be an emerging player in the growing pharmaceutical industry has great potential to improve health care worldwide by using breakthrough products that are both economical and easy to manufacture.

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