3. Provectus has been flogging the same non-randomized (single arm) PV-10 phase II study data since 2009. The data are stale, which goes a long way towards explaining why FDA said no to BTD.
May 14, 2009: Provectus announced the completion of patient enrollment in the PV-10 phase II study.
May 18, 2009: Provectus presents interim results from 20 patients in the PV-10 phase II study.
June 1, 2009: Provectus presents interim results on 40 patients in the PV-10 phase II study at the ASCO annual meeting.
May 21, 2010: Provectus presents another update on 40 patients in the PV-10 phase II study at the ASCO annual meeting.
Nov. 5, 2010: Provectus announces full phase II data on PV-10, presented at the Melanoma 2010 Congress.
June 29, 2011: A full presentation of the PV-10 phase II results made at the 7th European Association of Dermato-Oncology conference. Note: This presentation includes specifics about the design of the PV-10 phase III study which was never started.
June 26, 2012: Provectus again presents final data from PV-10 phase II study at the European Post-Chicago Melanoma Meeting 2012, Interdisciplinary Global Conference on Developing New Treatments for Melanoma.
Oct. 2, 2012: Provectus presents final data from PV-10 phase II study again(!) at the European Society for Medical Oncology 2012 Congress.
Sept. 12, 2013: Deja vu? Provectus presents additional results from PV-10 phase II study at the European Cancer Congress.
May 14, 2014: Provectus previews a subset analysis of the same PV-10 phase II study to be presented at the American Society of Clinical Oncology annual meeting.
4. Provectus is spinning when it tells investors that a short bridging study will be enough to compile the data necessary for FDA to review and approve PV-10.
What is PV-10 designed to do? On Friday's call, Chief Technology Officer Wachter said PV-10 is being developed to improve melanoma "symptoms."
"Our assumption going into the application was that improvement in symptoms... if we make the patients' lesions go away that's tantamount to making the patients' symptoms of that disease go away. We don't seem to have been successful in convincing the agency of that," Wachter said. According to Provectus, symptoms of melanoma include pain, bleeding or infections.
Unfortunately, improving the symptoms of melanoma isn't the same as treating melanoma. Injecting something into a melanoma lesion and making it disappear isn't necessarily a clinical benefit for patients because melanoma is a systemic disease. The most visible manifestation of melanoma are skin lesions, but cancer cells can spread to nearby tissues and lymph nodes even in early stage disease. These cancer cells can survive and spread even if the skin lesion is gone. In more advanced melanoma, the cancer cells spread to distant lymph nodes and other organs.
Every other company developing "intra-lesionally injected" melanoma drugs knows this about the disease, which is why Amgen (AMGN - Get Report), for instance, designed a large, randomized phase III study of its engineered oncolytic virus T-Vec with a primary endpoint assessing durable overall response (defined as a complete or partial response lasting six months or longer.) T-Vec demonstrated a statistically significant improvement in durable overall response compared to an active comparator, the immune booster GM-CSF. But this positive result wasn't sufficient for Amgen to seek FDA approval of T-Vec. Amgen had to also show T-Vec prolonged survival compared to the active comparator -- something the drug hasn't quite done yet. T-Vec's future is cloudy.
Vical (VICL - Get Report) also developed a drug injected directly into melanoma lesions. A large phase III study with primary endpoints of overall response rate and overall survival failed last year.
Provectus, Amgen and Vical enrolled similar melanoma patients into their respective clinical studies.
Melanoma doctors aren't interested in a drug which improves melanoma "symptoms" without also impacting the underlying disease. Why would they? Melanoma, left untreated, is fatal. Treating melanoma symptoms only is a waste of time. Provectus knows this, of course, which is why comments made by Wachter and Culpepper Friday are purposefully evasive, and in my opinion, totally misleading.
Provectus Executive Actions Worthy of FDA, SEC Investigations
Check Out Our Best Services for Investors
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Model portfolio
- Stocks trading below $10
- Intraday trade alerts