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Taking Cancer Treatment To A New Level (OTC:PVCT)

|Includes: Provectus Biopharmaceuticals, Inc. (PVCT)

Provectus Pharmaceuticals, Inc.

(Public, OTC:PVCT)

StocksHaven Investments profiles one of the most exciting up-and-coming anti-cancer companies in the industry, Provectus Pharmaceuticals (OTC:PVCT). They have one of the deepest pipelines of any small cap biotech, focusing on treatments for: Melanoma, Psoriasis, Atopic Dermatitis, Breast Cancer, and Liver Metastasis. With three drugs nearly ready to enter Phase III, including one nearly entering Phase II for Breast Cancer, one of the largest target markets worldwide and seeking “compassionate use” in Australia and USA, look for Provectus to make a splash within the next couple of months.

They are developing and testing one of the most exciting anti- cancer compounds. It has been demonstrating significant effectiveness against Melanoma in Phase 2 clinical trials and it offers promising treatment for breast, liver and other solid tumor based metastatic cancers. The compound developed by Provectus, known as PV-10, is a liquid that is injected directly into certain types of tumors and has been shown to obliterate many of them with little or no toxic side effects.

Further, Provectus researchers have also seen something which was initially unexpected. Injection of the compound often causes a reduction in non-targeted tumors as well as the ones that have been directly injected. This surprising systemic effect is called the “bystander effect”. It also suggests the emergence of a powerful and safe systemic anti-metastatic treatment.

The primary ingredient in the compound, known as PV-10, has a long history of use as a “maker die” and is known to have few, if any, toxic side effects in humans and other mammals. The current trials have been confirming the general safety of the compound. Provectus is moving as quickly as it can, without sacrificing the integrity of the study, to complete its Phase 2 clinical trials on Melanoma, to move forward on Phase 1 trial in liver and perhaps Phase 2 in breast cancer and to open up PV-10 for “compassionate use” in both Australia and the US. A compassionate use application is one where other cancers are treated beyond any FDA protocol.

About Provectus Pharmaceuticals

Provectus Pharmaceuticals, Inc., is a development-stage biopharmaceutical company that is focusing on developing invasive products for the treatment of psoriasis and other topical diseases, and certain forms of cancer including recurrent breast carcinoma, metastatic melanoma and liver cancer. The Company through its subsidiaries develops, licenses, markets and plans to sell products in three sectors of the healthcare industry, which include Over-the-counter products (OTC products), Prescription drugs and Medical device systems. The Company conducts its business through its seven wholly owned subsidiaries, namely Xantech Pharmaceuticals, Inc., Pure-ific Corporation, Provectus Biotech, Inc., Provectus Devicetech, Inc., Provectus Imaging, Inc., IP Tech, Inc. and Provectus Pharmatech, Inc. The Company’s prescription drug products encompass the areas of dermatology and oncology and involve several types of small molecule-based drugs.

Products ( click image to enlarge )

PV-10 for Melanoma

Melanoma is a malignant tumor of melanocytes which are found predominantly in skin but also in the bowel and the eye. It is one of the less common types of skin cancer but causes the majority (75%) of skin cancer related deaths. Melanocytes are normally present in skin, being responsible for the production of the dark pigment melanin. Despite many years of intensive laboratory and clinical research, the greatest chance of cure is in the early surgical resection of thin tumours.

Around 160,000 new cases of melanoma are diagnosed in the US each year, more frequently in males and Caucasians. It is more common in Caucasian populations living in sunny climates than in other groups, or in those who use tanning salons. According to a WHO report about 48,000 melanoma related deaths occur worldwide per year. [ Figures from Wikipedia ]

To trully understand how well PV-10 has worked in the treatment for Melanoma, see the presentation poster here.

Positive Phase I and Phase II Clinical Trials

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.

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.

Skin Cancer Rising at an Alarming Rate

Melanoma is a disease of the skin in which cancer cells are found in the cells that color the skin (melanocytes). It is the least common but fastest growing and most dangerous type of skin cancer. Although melanoma normally occurs in adults, there have been cases of this cancer in adolescents as well.

Overall, skin cancer is the most commonly occurring cancer in the United States. It accounts for one percent of all cancer deaths – a staggering 9,200 deaths each year. Most malignant melanomas occur in individuals between 25 and 29 years of age.

Approximately 90 percent of all skin cancers can be attributed to sun overexposure. The Earth’s natural Ozone layer is what protects us from over exposure of UV-rays which cause skin cancer, however there is a real danger growing. A phenomenon caused by our greenhouse gases which is reacting with our Ozone layer to create a hole which lets these cancer-causing UV-rays in our atmosphere!

The lead investigator for Provectus’ Phase 2 study of PV-10 for metastatic melanoma, Professor John F Thompson, MD, presented the update on Provectus’ development efforts at The Sixth International Symposium on Melanoma and Other Cutaneous Malignancies on March 13, 2009 in New York City. A detailed analysis of the interim Phase 2 study results will be made available at the 2009 American Society of Clinical Oncology (OTC:ASCO) Scientific Program on May 29 – June 2, 2009 in Orlando, Florida.”

Melanoma Gaining Worldwide Exposure ( taken from Ezine Articles )

Ever wonder which celebrities have had skin cancer and either beaten it or unfortunately died from the disease? There is a great deal of information to be learned through the different cases of cancer. There are many types of cancer. Cancer of the skin has recently been the number one case of cancer and has already taken many lives. However, there are those who have battled skin cancer and have won.

Cybill Shepherd – Had her battle of skin cancer in 2002. It was bad enough that it warranted surgery. Like many celebrities who have suffered skin cancer, Cybill Shepherd showed that she was a survivor. The 52 actress of the long running television show “Moonlighting” can count herself lucky because the cancer was not that serious, a single growth on her back,

Elizabeth Taylor – Suffered from skin cancer in 2002 as well and had surgery to get rid of the cancer. The 70 year old actress of “Cleopatra” has battled through and won the fight. Luckily there are no signs of the cancer even being there. With the surgery completed, Miss Taylor can continue with her life and be known as a survivor.

Here’s more: Ronald Reagan, Bob Marley, John McCain, Eva Cassidy, Sam Donaldson, Anderson Cooper. Some have lost. Some have won.

Presentation at the Rodman & Renshaw 11th Annual Healthcare Conference on September 10, 2009

PV-10 for Psoriasis, Atopic Dermatitis, Breast Cancer, and Liver Metastasis

Provectus Pharmaceuticals is also tackling the challenges of treating Psoriasis, Atopic Dermatitis, Breast Cancer, and Liver Metastasis. These products represent target market potentials in the billions, and initiate the company as having a bright future on product potential alone. To find out more on the potential of these products, as well as tracking of the ongoing clinical trials visit the company’s website.

Technical Chart Analysis ( click image to enlarge )

Since the beginning of August daily volume for PVCT has been on the rise, experiencing up to a 16000% increase in daily volume!  This indicates an enormous interest in this company and its activities as of late.  Also, the year to date price action has established a well defined and rising price channel shown in Blue on the chart.  If you’re looking to finally get in at the beginning of a price run, this could be the stock! Just this month, along with the jump in volume, the price has started to lift-off from the bottom trend-line of the rising price channel. Also, a stochastic oscillator currently indicates an oversold condition and this further enforces the probability that positive momentum is just starting to rise.  There appears to be a resistance level around .99 cents and this also looks to correspond to the next Blue channel line.  The price has already tested this level twice in the past week and as we have seen before the third time is the charm.  The next trend-line above the .99 cent area is the mid-line of the price channel. This mid-line is currently around $1.15, but rising everyday.  It’s good to keep in the back of your mind, that during the month of September last year, the price had a big run from 1.21 to 1.78 which seems to correlate to released clinical trail information.  A similar move would easily see this stock at $1.40 (the top of the current price channel) or beyond.  One will have to keep an eye on this stock because a move over $1.40 could expand the price channel up to almost $2.00.

Overall Sentiment

With a target market in the billions, proven effective Phase I and Phase II clinical trials for its products, and a price near the 52wk low, an investment in Provectus Pharmaceuticals Inc. could pay off in the near future. Yahoo based on analyst opinion has rated it a Strong Buy, with a mean target price of $3.75 per share.

We also see a strong bullish signal from the 22% shares being held by insiders. This represents a strong belief in the company’s products which will eventually meet requirements for an NDA, and meeting with the FDA. This process could take upwards of a year or longer, therefore long-term investors should be well rewarded for hanging onto the stock. However, short-term investors should be attracted by the current price which is near the 52wk low of 0.75. As our chart analysis depicts, a move over $1.40 could expand the price channel up to almost $2.00.


Disclosure: Position in PVCT