Celsion Looking To Break Liver Cancer (CLSN)
Celsion Corp. (NASDAQ: CLSN) has announced that its global Phase III Primary Liver Cancer trial is proceeding as planned. After receipt of FDA agreement in January of 2008 for its pivotal Phase III Primary Liver Cancer trial in the United States, Celsion says that it has obtained regulatory approval to conduct its Phase III safety and efficacy study of ThermoDox® in Hong Kong, Taiwan, Korea, Canada, and Italy. It also anticipates that a clinical trial agreement will be obtained in China before the end of 2008.
Celsion also noted that site initiation and patient enrollment are tracking well against its most recent projections.
Celsion also reported that Yakult Honsha is proceeding with plans to initiate a clinical program in Japan to study ThermoDox® for the treatment of primary liver cancer. As previously announced, Yakult will begin pre-clinical and clinical studies of ThermoDox® to support requirements for drug registration in Japan.
This stock made a major downside mystery move yesterday. It also doesn’t take much to move the stock as it only traded 46,000 shares yesterday. Some of the prioce moves may be exaggerated or stretched as well because of its wide bid-ask spread.
If the stock market continues in the same sort of swings it has been lately, they may have many more self-medicating via booze client down the road.
Jon C. Ogg
September 24, 2008
Vertex Shows Success in Hepatitis C Interim Data (VRTX)
Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) is seeing shares rise pre-market on new data regarding its Genotype 1 Hepatitis C treatment. Vertex’s PROVE 3 is an ongoing Phase IIb study evaluating telaprevir-based treatment in patients with genotype 1 chronic hepatitis C virus infection who did not achieve sustained virologic response with at least one prior regimen. Vertex is developing telaprevir in collaboration with Tibotec.
Here is a brief summary of the statistics without going deep into medical details:
- 52% SVR 12 rate for a 24-week Telaprevir-based Regimen in patients who failed prior treatment efforts;
- 73% of prior relapsers achieved SVR12 with 24-week telaprevir-based treatment;
- 41% of prior non-responders achieved SVR12 with 24-week telaprevir-based regimen.
Adverse events in interim analysis were similar to those commonly observed with peg-IFN and RBV including fatigue, nausea, rash, headache, gastrointestinal disorders and anemia, and were consistent with those previously reported in patients being treated with telaprevir-based therapy in the PROVE 1 and 2 studies in treatment-naïve subjects.
Vertex and Tibotec plan to initiate a Phase III clinical trial in patients who have failed prior treatment with peg-IFN and RBV. Telaprevir (TVR) is the most advanced HCV protease inhibitor in clinical development targeting treatment of chronic hepatitis C, and is in Phase 3 clinical development in treatment-naïve patients. Hepatitis C is a disease that afflicts more than 3 million people in the United States alone, and 170 million worldwide.
PROVE 3 is a randomized, double-blind, placebo-controlled Phase IIb study that enrolled patients who failed prior treatment with peg-IFN and RBV. Patients enrolled in PROVE 3 included prior non-responders, prior relapsers and prior breakthroughs to peg-IFN and RBV treatment. The interim analysis included 453 patients that were enrolled and received at least one dose of study drug.
Vertex close dat $32.24 Friday and shares were down at $28.00 5 days ago. Shares are now trading up over $35.00 in pre-market trading and its 52-week trading range is $13.84 to $41.42.
Jon Ogg
June 9, 2008