Frustrating as $PVCT has been lately, i think patience will pay off.
Company seems to have alot in the works.
This was a $3.50 penny stock before up listing.
Here is more news!
Eye-dye melanoma try: Provectus phase III plan for injectable with FDA
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provectus_nov._14_2014.jpg
By Randy Osborne
Staff Writer
With its injectable version of a topical stain approved to detect eye damage – the first-ever therapeutic use of rose Bengal – on the runway for phase III trials in melanoma, Provectus Biopharmaceuticals Inc. has offered the FDA a comparator-study protocol, while pursuing earlier-stage work with PV-10 in breast and liver tumors as well.
Peter Culpepper, chief financial officer of Knoxville, Tenn.-based Provectus, said Monday in a conference call on third quarter earnings that the firm expects word from U.S. regulators in 30 to 45 days and expects "few if any significant issues to arise," since the firm has had "substantive contact" with the agency since the type C meeting held in mid-December 2013.
The proposed phase III study will compare PV-10 with dacarbazine or temozolomide chemotherapy in patients who are BRAF V600E wild-type and have failed or are not otherwise candidates for Yervoy (ipilimumab, Bristol-Myers Squibb Co.) or another immune checkpoint inhibitor. Subjects in the comparator arm will get the investigator's choice of dacarbazine or temozolomide, and efficacy will be gauged by progression-free survival (PFS) between all intent-to-treat subjects in the two treatment arms, assessed every 12 weeks up to 18 months.
Officials of the company were in Zurich, Switzerland, attending the Society for Melanoma Research 2014 International Congress, and could not be reached. Discussing positive phase II results almost four years ago, when they were unveiled at the Melanoma 2010 Congress in Sydney, the firm's chief technology officer Eric Wachter said Provectus had proven PV-10's safety in multiple studies and could "say with a reasonable amount of certainty that going forward we expect those trends to continue, and should those trends continue and once we have sufficient numbers of patients, we should have an approvable drug."
The phase III experiment, if the FDA approves the protocol, will tell the tale. For melanoma and hepatocellular carcinoma, the company has gained orphan drug status from the FDA, but the agency has been less cooperative about breakthrough designation, denying Provectus' bid in May of this year. In its notification letter, the FDA told Provectus "the preliminary clinical evidence you submitted does not indicate that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints," so the request for breakthrough standing was denied.
Provectus CEO Craig Dees noted at the time that "only about one-third of [breakthrough] requests are granted, and no intralesional drugs have received designation," so the turndown was not entirely surprising.
In the 80-patient phase II melanoma study, an objective response (OR) turned up in 49 percent of subjects, with 71 percent achieving locoregional disease control (stable disease or better) in their injected lesions. A mean PFS of 11.7 months was observed among the patients with ORs. Final results worked out statistically equivalent to the interim phase II data on the first 40 subjects.
Still at the phase II stage, Provectus has in the works another form of rose Bengal, known as PH-10, in psoriasis and atopic dermatitis. During the third quarter earnings call earlier this week, Wachter said Provectus is "in the process of manufacturing study group for the next step in the psoriasis, which is a clinical trial to assess changes that may occur in psoriatic plaque upon daily application of PH-10," adding that the company expects the study "to shed light on clinical observations from prior studies of PH-10 in both psoriasis and atopic dermatitis." The study is expected to start early in the first quarter of next year.
CHINA TALKS TO TEE UP
Rose Bengal takes its name from the red hue similar to that of the dot that signals marriage on the foreheads of women in Bengal and other parts of India. It was apparently first patented in Switzerland in 1885, by an inventor of wool dye.
In the 1900s, rose Bengal began showing up as the ocular staining agent as well as part of an intravenous assay of liver function. In the mid-1980s, Japanese researchers published findings in the Journal of the National Cancer Institute that suggested a therapeutic benefit in mice with thyroid cancer, and rose Bengal research took off in the years that followed, according to Sanjiv Agarwala, writing in The Melanoma Letter in 2012. (See BioWorld Today, May 24, 2010.)
With regard to the projected phase III trial in melanoma, Provectus' Wachter said during the earnings call that Provectus has "been pursuing a program throughout the year to develop additional relationships with investigators geographically in the U.S. and Australia and potentially in other parts of the world," with "several investigator meetings in the coming weeks. So I think we have a good handle on how to build out the study at an investigator and institutional level."
Provectus made news in August by opening PV-10 licensing talks in China. The firm entered a memorandum of understanding with Sinopharm-China State Institute of Pharmaceutical Industry, the leading pharmaceutical research institute there, and Sinopharm A-Think Pharmaceutical Co. Ltd., which is the only injectable antitumor drug research and development, manufacture and distribution integrated platform within Sinopharm Group.
During the ensuing three months, the parties said they would try to put together a definitive licensing contract, subject to additional negotiation, due diligence, and any required regulatory and corporate approvals.
Culpepper said during the conference call that, since China is bound by the International Congress of Harmonization's rules, "be it for Sinopharm or for any pharmaceutical entity that we're talking to in China, they're interested in participating in our clinical development in China. So they want the protocols filed with our own FDA and then we do the appropriate release testing, we control the supply chain. What they are focused on are the protocols for liver and for melanoma particularly."
Company seems to have alot in the works.
This was a $3.50 penny stock before up listing.
Here is more news!
Eye-dye melanoma try: Provectus phase III plan for injectable with FDA
Share
provectus_nov._14_2014.jpg
By Randy Osborne
Staff Writer
With its injectable version of a topical stain approved to detect eye damage – the first-ever therapeutic use of rose Bengal – on the runway for phase III trials in melanoma, Provectus Biopharmaceuticals Inc. has offered the FDA a comparator-study protocol, while pursuing earlier-stage work with PV-10 in breast and liver tumors as well.
Peter Culpepper, chief financial officer of Knoxville, Tenn.-based Provectus, said Monday in a conference call on third quarter earnings that the firm expects word from U.S. regulators in 30 to 45 days and expects "few if any significant issues to arise," since the firm has had "substantive contact" with the agency since the type C meeting held in mid-December 2013.
The proposed phase III study will compare PV-10 with dacarbazine or temozolomide chemotherapy in patients who are BRAF V600E wild-type and have failed or are not otherwise candidates for Yervoy (ipilimumab, Bristol-Myers Squibb Co.) or another immune checkpoint inhibitor. Subjects in the comparator arm will get the investigator's choice of dacarbazine or temozolomide, and efficacy will be gauged by progression-free survival (PFS) between all intent-to-treat subjects in the two treatment arms, assessed every 12 weeks up to 18 months.
Officials of the company were in Zurich, Switzerland, attending the Society for Melanoma Research 2014 International Congress, and could not be reached. Discussing positive phase II results almost four years ago, when they were unveiled at the Melanoma 2010 Congress in Sydney, the firm's chief technology officer Eric Wachter said Provectus had proven PV-10's safety in multiple studies and could "say with a reasonable amount of certainty that going forward we expect those trends to continue, and should those trends continue and once we have sufficient numbers of patients, we should have an approvable drug."
The phase III experiment, if the FDA approves the protocol, will tell the tale. For melanoma and hepatocellular carcinoma, the company has gained orphan drug status from the FDA, but the agency has been less cooperative about breakthrough designation, denying Provectus' bid in May of this year. In its notification letter, the FDA told Provectus "the preliminary clinical evidence you submitted does not indicate that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints," so the request for breakthrough standing was denied.
Provectus CEO Craig Dees noted at the time that "only about one-third of [breakthrough] requests are granted, and no intralesional drugs have received designation," so the turndown was not entirely surprising.
In the 80-patient phase II melanoma study, an objective response (OR) turned up in 49 percent of subjects, with 71 percent achieving locoregional disease control (stable disease or better) in their injected lesions. A mean PFS of 11.7 months was observed among the patients with ORs. Final results worked out statistically equivalent to the interim phase II data on the first 40 subjects.
Still at the phase II stage, Provectus has in the works another form of rose Bengal, known as PH-10, in psoriasis and atopic dermatitis. During the third quarter earnings call earlier this week, Wachter said Provectus is "in the process of manufacturing study group for the next step in the psoriasis, which is a clinical trial to assess changes that may occur in psoriatic plaque upon daily application of PH-10," adding that the company expects the study "to shed light on clinical observations from prior studies of PH-10 in both psoriasis and atopic dermatitis." The study is expected to start early in the first quarter of next year.
CHINA TALKS TO TEE UP
Rose Bengal takes its name from the red hue similar to that of the dot that signals marriage on the foreheads of women in Bengal and other parts of India. It was apparently first patented in Switzerland in 1885, by an inventor of wool dye.
In the 1900s, rose Bengal began showing up as the ocular staining agent as well as part of an intravenous assay of liver function. In the mid-1980s, Japanese researchers published findings in the Journal of the National Cancer Institute that suggested a therapeutic benefit in mice with thyroid cancer, and rose Bengal research took off in the years that followed, according to Sanjiv Agarwala, writing in The Melanoma Letter in 2012. (See BioWorld Today, May 24, 2010.)
With regard to the projected phase III trial in melanoma, Provectus' Wachter said during the earnings call that Provectus has "been pursuing a program throughout the year to develop additional relationships with investigators geographically in the U.S. and Australia and potentially in other parts of the world," with "several investigator meetings in the coming weeks. So I think we have a good handle on how to build out the study at an investigator and institutional level."
Provectus made news in August by opening PV-10 licensing talks in China. The firm entered a memorandum of understanding with Sinopharm-China State Institute of Pharmaceutical Industry, the leading pharmaceutical research institute there, and Sinopharm A-Think Pharmaceutical Co. Ltd., which is the only injectable antitumor drug research and development, manufacture and distribution integrated platform within Sinopharm Group.
During the ensuing three months, the parties said they would try to put together a definitive licensing contract, subject to additional negotiation, due diligence, and any required regulatory and corporate approvals.
Culpepper said during the conference call that, since China is bound by the International Congress of Harmonization's rules, "be it for Sinopharm or for any pharmaceutical entity that we're talking to in China, they're interested in participating in our clinical development in China. So they want the protocols filed with our own FDA and then we do the appropriate release testing, we control the supply chain. What they are focused on are the protocols for liver and for melanoma particularly."
I'm in it to win it!
NASDAQ DIP and RIP
Here is the best word that describes what i do here.
Intuitive;
means having the ability to understand or know something without any direct evidence or reasoning process.
I was born with it, I'm truly blessed!
Alway's searching for winners'
NASDAQ DIP and RIP
Here is the best word that describes what i do here.
Intuitive;
means having the ability to understand or know something without any direct evidence or reasoning process.
I was born with it, I'm truly blessed!
Alway's searching for winners'
