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Biotech / Medical : Tularik Inc. (TLRK) -- Ignore unavailable to you. Want to Upgrade?

To: Czechsinthemail who wrote (227)	6/14/2002 12:18:59 AM
From: keokalani'nui	Read Replies (2) \| Respond to of 598

Not a negative take, but company did not really take on the T67 bear case. The bear case being that they are going ahead without any data on what will likely be the P3 endpoint. Also did not really explain what is going on with the p2 combo and didn't even mention the plan to shorten dose admin. 40 min is not much time I know and someone could have asked duirng the presentation (it was obliquely asked during breakout), so I am only pointing out an opportunity was missed to show conviction. OTOH, it sounds like (my guess is) PPar-g (this would be the one of the five Goeddel has in the past said is not a novel target) will be within the first group to go into clinic and I am personally hoping HDL is with that first group also. All are very potent, very specific, and it sounds like all are highly, highly characterized pre-IND candidates. BTW, even though there is no approved HCC treatment, don't you think the FDA is going to expect improvement over dox? Wilder

To: Czechsinthemail who wrote (227)	6/14/2002 8:47:36 AM
From: rkrw	Respond to of 598

<<With about a million cases of HCC per year, it could be very big.>>> The 1M estimate is extremely skewed since almost all of this is in the Far East and parts of Africa. In the US its still relatively rare, with an est 4-6,000 cases per year. sti.upmc.edu I do expect hcc's US prevalence to jump dramatically in the next 10 years as an aftereffect of the jump in HCV. Here's a link for nonsurgical treatment options: rad.unipi.it NONSURGICAL TREATMENTS (HCC) ---------------------------------------------------------- The prognosis for patients with unresectable hepatocellular carcinoma (HCC) tumors is extremely poor. Even in the case of small nodular lesions detected by US screening, patients receiving no treatment showed a mean 3-year survival rate of 12% (29). Among nonsurgical options, Percutaneous Ethanol Injection (PEI) can be considered the treatment of choice for patients with small (3 cm or less in diameter) HCC tumors. Studies in Japan and in Italy demonstrated the possibility to achieve complete alcohol-induced necrosis of such small lesions, without adverse effects on the noncancerous liver parenchyma (10,11). Moreover, patients treated with PEI showed high long-term survival rates, comparable with those of patients submitted to surgical resection (12,13). The greatest drawback of PEI is represented by the difficulty to treat tumors larger than 3 cm. In these cases, alcohol diffusion is incomplete, being impeded by the texture of the tumor. As a result, residual viable neoplastic tissue can be found after treatment, particularly along the periphery of the nodule or in portions isolated by septa (30). Transcatheter Arterial Chemoembolization (TACE) , most frequently performed by intraarterially injecting an infusion of antineoplastic agents mixed with iodized oil (Lipiodol (R)), has been extensively used in the treatment of large HCC tumors (14,15). However, although massive tumor necrosis can be demonstrated in most cases, a complete necrosis of the tumor has rarely been achieved with TACE, since residual tumor can be found in a nonnegligible number of the treated lesions (31). Indeed, TACE was found mostly effective in nodules less than 4 cm in diameter, with a thick tumor capsule. In fact, small, encapsulated HCC are almost completely fed by hepatic arterial blood and therefore highly responsive to hepatic arterial embolization. On the contrary, in unencapsulated tumors or in tumors showing extracapsular invasion of neoplastic cells, TACE often fails to induce complete necrosis since tumor cells, either unimpeded by the absence of a capsule or spreading across the capsule itself, invade the adjacent liver parenchyma, thus obtaining additional blood supply from the sinusoidal portal system. Large HCC lesions can be more effectively treated with combined TACE and PEI. In fact, alcohol diffusion is easier after the occurence of the necrotic changes produced by TACE, thus allowing the intranodular injection of larger amounts of ethanol (17). Moreover, after arterial embolization, the normal wash-out of the injected ethanol is more difficult in the tumorous area, resulting in longer retention of the substance. The combination of TACE and PEI seems to be a highly effective treatment for large HCC also in the instances when daughter nodules are associated with a main tumor (18). The presence of the capsule significantly enhances the chances of success and should be considered an important requirement when selecting patients to be submitted to TACE and PEI (18). Here's another site which shows survival estimates for various treatment options and stages of hcc. sti.upmc.edu Maybe others can help answer: what will tlrk be comparing it's t-67 against in the phase III? If dox as was pointed out here, is dox really the treatment of choice??? Will they be trying combo's with est standards of care? e.g. TACE and PEI? Are they addressing only the subsection of hcc, nonresectable later stage patients? As I understand it, chemo isn't used with hcc because it isn't effective (maybe toxing the liver has something to do with this :-) but that doesn't mean there are zero treatment options. I asked tlrk for details and got no response other than a very thin IR packet sent in the mail!