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163305 tn?1333668571

A New And Interesting Addition To The Hep C Clinical Pipeline

http://seekingalpha.com/article/929921-a-new-and-interesting-addition-to-the-hep-c-clinical-pipeline

The race towards an interferon-free hepatitis C treatment continues to heat up, with a newcomer to the clinical pipeline - BioLine Rx's (BLRX) BL-8020. The Israeli company, which in-licensed the drug earlier this year, announced that it had successfully completed the pre-clinical development of the anti Hep C drug, and that a phase I/II is planned to begin in Europe during the first quarter of 2013.

Unlike the vast majority of Hep C drugs under development, BL-8020 is not a protease or polymerase inhibitor. In fact, this drug doesn't directly target the hepatitis virus at all, but instead, targets the host cell. BL-8020 inhibits a naturally occurring mechanism in the cell termed "autophagy", which is used by the hepatitis C (and other viruses) for its replication process. This unique mechanism of action provides BioLine's drug with several advantages:

1. BL-8020 can potentially be combined with any other anti-Hep C drug as part of an all oral, interferon-free cocktail.

2. Targeting the host cell rather than the virus itself is very likely to result in an effective treatment of all the Hep C genotypes. Until today, most drug candidates are mostly effective in genotype-1 patients.

3. The different MOA could be beneficial when approaching patients who failed to respond to SOC treatment.

Looking at protocols used in previous early-stage clinical studies with Hep C drug candidates, we can assume that several dozens of patients will be enrolled in the upcoming trial, and results can be expected within about a year. It will be interesting to see which drug cocktail (if any) will be tested by BioLine in this study, and whether the company will challenge itself with non-responders, or will enroll treatment naïve patients only. In my opinion, the latter subject is of critical importance - some experimental Hep C agents proved effective in treatment naïve patients, but failed to produce similar success when tested on patients who have not responded to previous treatment.

The nature of clinical trials with Hep C treatments promises a trickle of information throughout the duration of the study, with endpoints at several time points of the treatment, mainly at weeks 4 and 12. Such expected interim data may cause surges in BioLine's stock price and interested investors should closely monitor this already volatile stock.

Analysis of the Hep C pipeline reveals that there are currently 14 agents in phase I, 19 agents in phase II, and 4 in phase III. However, the vast majority of these drug candidates is directed against only 4 targets, and is being developed by a handful of companies, including Abbott (ABT), Gilead (GILD), Achillion (ACHN), Boehringer Ingelheim, Bristol-Myers Squibb (BMY), Vertex (VRTX), Idenix (IDIX) and Merck (MRK). This results in a very competitive field on one hand, and high levels of "cross-reactions" on the other, as seen in the case of BMS and Idenix last August.

Besides BL-8020, noteworthy anti-Hep C agents that do not target the NS3/4/5 viral proteins are iTherX's ITX-5061 (virus entry inhibitor), and Biotron's (ASX:BIT) BIT225 (viral assembly inhibitor). These two agents, currently in Phase I and II respectively, deserve a close look by investors following the advancements in the Hep C field.

Should BL-8020 prove to be a safe and effective drug as a part of an all oral anti-Hep C cocktail, it is bound to attract the attention of several players in the field, mainly due to its outside the box therapeutic approach to Hep C treatment.
6 Responses
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3230925 tn?1397615965
That is great news.There is no one size fits all treatment so far.Maybe the future will have a few options on how to treat that are equally effective.
Helpful - 0
2061362 tn?1353279518
Thanks for posting OH. @ Maragret, always have and will continue to plug your very important cause, as I think everyone does. :)
Helpful - 0
163305 tn?1333668571
While I have signed the petition and urge others to do the same, this is news from outside the US.

I agree with you that it is shameful that Gilead refuses to work with Bristol.

However, I'm curious if this new med is successful outside the US, if perhaps we'll see different treatments in different places.
Helpful - 0
1689583 tn?1387752394
I am glad you found the article , as I mentioned in my original post it is always good news when we hear of other options in the race towards the cure ,
Helpful - 0
1797925 tn?1341096204
Lest  we lost site completely of the two drugs that indeed cured 100% of genotype 1 and < 91 percent of genotype 2l3 without interferon or ribavirin
with minimal so no side effects...once again.  The only  drug combination that achieved this was daclatasvir and GS-7977 (now sobosbuvir.  
Helpful - 0
163305 tn?1333668571
http://hepatitiscresearchandnewsupdates.blogspot.com/2012/10/biolinerx-reports-successful-hepatitis.html#.UIGYA2e7lAh

BiolineRX reports successful hepatitis C preclinical trial

The company will launch a human Phase I/II clinical trial in Europe to test the drug's safety and efficacy during the first quarter of 2013.

16 October 12 13:51, Globes' correspondent

BiolineRX Ltd. (Nasdaq: BLRX); TASE:BLRX) today announced success in a preclinical trial of it oral treatment for hepatitis C, BL-8020, and that it will launch a human Phase I/II clinical trial in Europe to test the drug's safety and efficacy during the first quarter of 2013

BL-8020 has a unique mechanism of action for treating hepatitis C, compared with other current treatments, which suggests that it is effective across different strains and can be combined with other therapeutics as part of an interferon-free regimen. BL-8020 inhibits hepatitis-induced autophagy (a mechanism by which cells degrade damaged or unnecessary cellular components, including invading viruses) in the host cells, thereby reducing the ability of the hepatitis virus to replicate.

BiolineRX has an exclusive worldwide license for BL-8020 from France Genoscience SA

BiolineRX CEO Dr. Kinneret Savitsky said, "The unique characteristics of BL-8020 make it attractive as an adjunct therapy to other oral cocktail therapies, therefore not directly competing in the crowded hepatitis market of currently approved therapies or those under development."

BiolineRX's share price rose 10.5% on the TASE today, following the announcement to NIS 1.28, after closing at $3.05 on Nasdaq yesterday, giving a market cap of $54 million.
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