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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Arthur Radley who wrote (19394)	3/22/2006 12:03:02 AM
From: dr.praveen	Respond to of 52153

HCV data of Coley's: I'll try to take a stab at it though I am not an expert in this field:-) The salient points in the data released: Preliminary data from the study indicate that 12 out of 14 patients (86%) receiving a combination of Actilon with pegylated interferon and ribavirin achieved an Early Viral Response (greater than 2 log reduction in serum HCV RNA at 12 weeks), compared to 8 out of 14 patients (57%) who received a control combination of pegylated interferon and ribavirin. At twelve weeks, the Actilon combination therapy resulted in a 3.3 mean log reduction in HCV RNA level, compared to a 2.2 mean log reduction among patients receiving the control combination. The Actilon combination was well tolerated, and the kinds of adverse events observed were similar to those seen with the control combination. The study enrolled a total of 74 genotype 1 Hepatitis C patients who had previously received at least 24 weeks of treatment with pegylated interferon and ribavirin and who initially responded but subsequently relapsed within six months of treatment (relapsed responders). Subjects were randomly assigned to one of five groups, receiving twelve weekly doses of: * Actilon alone, * Actilon in combination with pegylated interferon, * Actilon with ribavirin, * Actilon with pegylated interferon and ribavirin, or * pegylated interferon and ribavirin. Patients who achieved at least a 2 log reduction in HCV RNA at 12 weeks are eligible to continue treatment for an additional 36 weeks. Actilon was administered once-weekly at a dose of 0.2 mg/kg. At twelve weeks, the Actilon combination therapy resulted in a 3.3 mean log reduction in HCV RNA level, compared to a 2.2 mean log reduction among patients receiving the control combination. My thoughts: 1)I feel that the efficacy data is good and might not be excellent in comparision to Vertex and SGP's data. 2) But the patients treated were more difficult to treat than those of vertex and sgp.74 relapsed responders and not direct HCV pts. All pt's are genotype 1 in all cases. 3)There might be resistance to VX 950 in the later studies as it only takes a single mutation in the HCV virus to become resistant. Both vertex and coley's drugs need to be studied more for toxicity. 4)I think that the sample size is small in coley's( even vrtx had a small sample) and no sub group data was released. But I guess they are going to present it as a late late-breaker oral session at the European Association for the Study of the Liver (EASL) meeting in Vienna. 5) VX 950 is oral but Coley's is an once weekly SC inj. If the interferon component is here to stay in Hep c rx which I think it might, I agree it might be a disadv to coley as one more SC inj, but might be 2 SC inj once a week is not a bad thing than taking oral tabs every day.Peg-intron(PEG interferon) is a pen which can be injected sc at home. But Hcv is a large early playfield and it's hard to guess how the rx combo shapes up in the future. JMHO, Regards, Praveen