I Think It's A Good Time To Be A $PVCT Shareholder [View instapost]
More than 200 people have been treated with the company's oncology and inflammatory skin disorder (dermatology) compounds (PV-10 and PH-10, respectively) in metastatic melanoma (Phase 2), breast cancer (Phase 1), liver cancer (Phase 1), atopic dermatitis (Phase 2) and psoriasis trials (Phase 2). There also is a oncology compassionate use (expanded access) program where patients also have been treated. You can find more information under the R&D tab on Provectus' website.
Currently, we await the outcome of management's efforts to seek regulatory clarity; specifically, whether the company can agree with the FDA on the design of a metastatic melanoma Phase 3 trial under special protocol assessment (SPA). An expectation is this will be achieved in Q2 2013. The company hopes to complete an expanded liver cancer (HCC) Phase 1 trial by the end of the 2013.
The Provectus-Pfizer Relationship Grows [View instapost]
The share price decline over the last month has not changed my investment thesis. $0.59 reflects market uncertainty caused by management's exploration of a preferred stock offering to list on the NASDAQ.
Pfizer will wait as long as it has to wait; however, I do not think the wait will be the 30-month trial period. The waiting should end shortly after the interim analysis of half the contemplated patient population of the trial (or ~90 people).
Interview With Vijay B. Samant, President And CEO, Vical Incorporated [View article]
The conjecture was from industry constituents; as such, I thought you might have been aware of such "inside baseball" speculation. The essence of my initial comment only was to gain your insight on endpoint design. The Cowen analyst, on the Q2 earnings call, summed up the situation of the delay and determination of the outcome well.
Interview With Vijay B. Samant, President And CEO, Vical Incorporated [View article]
Thank you for your response. I did not ask about interim analysis. I sought, among other things, your thoughts about the design of the primary endpoint. Vical's Phase 3 trial is not really "relatively small" compared to first Ipi trial; that is a 20-25% difference, depending on the denominator (I grant you the comparative difference of the other two trials). Nevertheless, endpoints and trial design dictate study size. Most studies have large or larger patient numbers because their effect size is lower, which means very incremental improvement. Vical probably did not design an interim analysis or efficacy read into their design (and thus did not provide patients in the control arm with a cross-over benefit) because such a design, as you point out, would have put a greater burden on the efficacy outcome. If Vical were supremely confident about the significance of the drug's results, management would have included an interim look and used an even smaller patient study size.
Interview With Vijay B. Samant, President And CEO, Vical Incorporated [View article]
This VICL article is informative and well written, in keeping with your previous ones.
What credence do you give to the conjecture VICL did not meet the primary endpoint in its pivotal MM Phase 3 study?
Mr. Samant commented: "Our Phase 3 trial was designed with no interim analyses for efficacy to keep it as small and cost-effective as possible. Because there were no interim looks at efficacy, there would be no basis to allow crossovers from the control group to the treatment group. The lack of crossovers also prevents compromise of the survival data."
Do you think the trial's primary endpoint was not as well designed as it should have been?
Mr. Samant's rationale of keeping it as small and cost effective as possible would be at odds with the large number of patients enrolled. The lack of a trial design feature to permit crossovers seems sub-optimal, despite his explanation of the potential for comprising survival data.
Investment Choices For Melanoma Awareness Month [View article]
Nice article. You are comparing OncoSec Phase 1 trial results to Provectus' Phase 2 trial results. Amgen shut down BioVex's other phase 3 trial, a head and neck cancer, for OncoVex. Good comment: "In order for biotech investors to make a decision on efficacy comparisons, the data set needs to be broken down for Provectus to determine how the patients responded as a whole in terms of complete response rate." That is why Dr. Sanjiv Agarwala's presentation of MM Phase 2 trial final data at the 2nd European PostASCO Melanoma Meeting 2012 in Munich on June 22 bears very close watching. http://bit.ly/KNmD12
I Think It's A Good Time To Be A $PVCT Shareholder [View instapost]
Currently, we await the outcome of management's efforts to seek regulatory clarity; specifically, whether the company can agree with the FDA on the design of a metastatic melanoma Phase 3 trial under special protocol assessment (SPA). An expectation is this will be achieved in Q2 2013. The company hopes to complete an expanded liver cancer (HCC) Phase 1 trial by the end of the 2013.
The Provectus-Pfizer Relationship Grows [View instapost]
Pfizer will wait as long as it has to wait; however, I do not think the wait will be the 30-month trial period. The waiting should end shortly after the interim analysis of half the contemplated patient population of the trial (or ~90 people).
I have not sold any shares.
Interview With Vijay B. Samant, President And CEO, Vical Incorporated [View article]
http://bit.ly/MfHeA5
Interview With Vijay B. Samant, President And CEO, Vical Incorporated [View article]
Interview With Vijay B. Samant, President And CEO, Vical Incorporated [View article]
What credence do you give to the conjecture VICL did not meet the primary endpoint in its pivotal MM Phase 3 study?
Mr. Samant commented: "Our Phase 3 trial was designed with no interim analyses for efficacy to keep it as small and cost-effective as possible. Because there were no interim looks at efficacy, there would be no basis to allow crossovers from the control group to the treatment group. The lack of crossovers also prevents compromise of the survival data."
Do you think the trial's primary endpoint was not as well designed as it should have been?
Mr. Samant's rationale of keeping it as small and cost effective as possible would be at odds with the large number of patients enrolled. The lack of a trial design feature to permit crossovers seems sub-optimal, despite his explanation of the potential for comprising survival data.
Investment Choices For Melanoma Awareness Month [View article]