2007

November 2007

November's always a pretty exciting month for Novel Therapy News, as liver docs from all over the world got together to party ... er, I mean, share the latest in research on getting rid of this damn disease ... at the annual AASLD.  It’s like a huge war on a very teeny scale.  Here's what we know so far ...

Now here’s a potential new treatment to watch.  It uses medicinal plants with this one.  But the goal for this drug would be to ease hep C symptoms – not kill the virus.  That’s cool, though. 

Phynova Group says phase I/II trial on hepatitis C drug candidate ...

Hemscott - London,UK

... data from the phase I/II trials of its lead drug candidate PYN17, for treating chronic hepatitis C, successfully confirms its safety and tolerability....

While the whole “cure” scene’s looking pretty bleak right now, scientists are hanging tough with new tries all the time – like this dutch biotech ....

OctoPlus says hepatitis C drug effective in study

Reuters UK – UK

With Locteron, OctoPlus is aiming to develop a treatment for patients with chronic hepatitis C, with fewer side effects and a more convenient dosing ...

When you’re doing hep C treatment, and your platelets plummet, some folks gotta just quit.  But now, there might be something that’ll help people stay on treatment – if they wanna, that is ...

GlaxoSmithKline Initiates Trials Of Promacta®/Revolade ...

Medical News Today (press release) – UK

The studies, ENABLE 1 and ENABLE 2 (Eltrombopag to INitiate and Maintain Interferon Antiviral Treatment to Benefit Subjects with Hepatitis C related Liver ...

Here we have a (potential) new drug, PD-1 – which stands for programmed celldeath, by the way – targets the hep C molecules that kill our liver cells, and seeks to kill them 1st.  We just hope it doesn’t take anybody out on the way.  Ya know?

Ono & Medarex Announce Allowance of Investigational New Drug ...
CNNMoney.com - USA
The new Phase I single-dose, dose-escalation trial with MDX-1106/ONO-4538 is expected to enroll up to 34 patients with active hepatitis C genotype 1 ...

Roche & Pharmasset’s new drug just got fast-track status by the FDA.    If approved, it would be used with the regular Pegasys & Copegus, but not for as long.  Fast Track status means it doesn’t have to jump through as many hoops.  Straightup ... we’re not convinced that’s necessarily a good thing.

UPDATE 2-Pharmasset's hepatitis C drug gets fast-track status
Reuters - USA
O: Quote, Profile, Research) said its chronic hepatitis C treatment, R7128, received fast-track status from US health regulators, sending shares up as much ...

Looks like Albuferon works as good as Pegasys here.  But ya only have to take it half as often.  Well ... this may not fall in the category of “good news” but ... we’re not sure which category it does fall in. 

Human Genome reports Phase IIB results for hepatitis C drug
CNNMoney.com - USA
Pegasys is a hepatitis C drug owned by Roche Pharmaceuticals. Human Genome, a Rockville, Md.-based pharmaceutical company said the trial achieved a ...

In the category of most original hep C drug this week, Glaxo-SmithKline (the folks who brought you the hep B vaccine & many others) is working on a drug that might help a lot of people endure the current treatment for hep C.

Glaxo starts Phase III hepatitis C Promacta tests
Reuters.uk - UK
Thrombocytopenia, or low-platelet levels, is a complicating factor in hepatitis C that can prevent patients receiving treatment.

BUMMER!  Vertex’s Telepravir – one of those inhibitor drugs – showed that only 50% of people on it cleared, and the side effects were way worse than had been hoped.  We’d throw this one in the Another-One-Bites-The-Dust category.

Vertex hepatitis C data fails to excite investors
Reuters - USA
O: Quote, Profile, Research) released data on Friday showing its experimental hepatitis C drug is more effective than existing treatments and works in half ...

 October 2007

Is it an interferon? Is it an inhibitor?  No ... it’s SUPER microRNA!  This one’s a long way from even becoming a drug, but still pretty interesting.  One of the project scientists working on this thing said, “Now that we have identified this new antiviral pathway or mechanism, pharmaceutical companies may be able to design a more effective therapy against the Hepatitis C virus.”  We’re for that.

Discovery Of New Antiviral Mechanism Promising For Hepatitis C ...
Science Daily (press release) - USA
“Approximately two percent of the human population worldwide is infected with Hepatitis C virus,” said Michael David, an associate professor of biological ...

This article offers a little appetizer tray of some of the new stuff to come out at next month’s Liver Meeting in Boston.  

Sneak a Peek at Promising Hep C Stocks
TheStreet.com - USA
By Adam Feuerstein BOSTON -- Research abstracts of data set for unveiling at next month's big hepatitis C meeting were published over the weekend, ...

Looks like we have another inhibitor drug in the running.  They just finished their phase I, and patients had a 2 log drop in 14 days.  Still ... don’t hold your breath for this one.  It’s got a ways to go.  Promises, promises ....

Pharmasset's Hepatitis C Drug Has A Promising Future
Seeking Alpha - New York,NY,USA
Pharmasset has programs for treating Hepatitis B and HIV, but what intrigues me the most is its Hepatitis C program. R7128 is a prodrug (meaning it gets ...

It looks like the darling of the new inhibitor drugs, Telapravir, is causing a rash & a little drop out problem in the current study that it’s in.  ... bummer.

Vertex hep C drug shows real promise, limitations
Reuters - USA
By Bill Berkrot NEW YORK (Reuters) - A closely watched hepatitis C drug being developed by Vertex Pharmaceuticals Inc continues to promise improvement over ...

*+“There’s a place in France where the ladies wear no pants”+ ... and they just might come up with a vaccine for hep C, too.

New Therapeutic Vaccine May Offer Hope for Chronic Hepatitis C ...
Associated Content - Denver,CO,USA
By Rafael B. According to a press release, everything is ready and set to test a new vaccine that may offer hope for people who suffer from Hepatitis C and ...

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September 2007

Excitement is hitting a petri dish near you!  Well ... maybe not you, ya thug ... but still....  These articles tell about a new chemical discovery that could lead to another potential cure some day: 

XTL Biopharmaceuticals presents new class of highly potent ...
Forbes - NY,USA
... with highly potent activity against the hepatitis C virus at the International Symposium on Hepatitis C Virus & Related Viruses in Glasgow, Scotland. ...

New hepatitis C virus findings from the United States and Italy ...
Therapeutics Daily (subscription) (press release) - Newtown,PA,USA
Studies from the United States and Italy have provided new information about hepatitis C virus. Study 1: Scientists discuss in "Hepatitis C virus induces ...

... but this one is the editor’s favorite.  It’s written pretty straight up for a mainstream journalist ....

Hepatitis-promoting protein caught in the act
Urbana/Champaign News-Gazette - Champaign/Urbana,IL,USA
The UI researchers and collaborators at Yale University and the Maryland-based Howard Hughes Medical Institute looked at a helicase from the hepatitis C ...

Roche is pretty jazzed about their polymerase inhibitor’s possibilities.  Upon their partner’s Phase I having been carried out for 14 days on 40 patients, the company reports that the drug "showed potent anti-viral activity" and "was well tolerated."  So, we can be relatively confident that no one in the study's died yet.

Roche's US partner Pharmasset says hepatitis C trial drug ...
Forbes - NY,USA
ZURICH (Thomson Financial) - Roche Holdings AG's US partner Pharmasset Inc said hepatitis C trial drug R7128 successfully lowered the level of the virus in ...

August 2007

Movin’ on up ....

Novartis Hep C drug clears Phase II
BiopharmaReporter.com - London,UK
By Kirsty Barnes 29/08/2007 - A long-acting biologic being co-developed by Novartis to treat chronic hepatitis C virus (HCV) has triggered a $40m (EURO 29.3m) ...

Another one enters the race ...

InterMune Announces Approval of Clinical Trial Authorization for ...
CNNMoney.com - USA
ITMN-191 is an orally available hepatitis C virus (HCV) protease inhibitor in development by InterMune and its partner, Roche. InterMune expects that the ...

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June 2007

If this one makes it ... it’d beat the hell out of the shots & pills & more pills ....

Oncolys BioPharma and Tacere Therapeutics Form Strategic Alliance
Earthtimes.org - USA
In preclinical animal studies, this "cocktail in one drug" targeted and cleaved the hepatitis C virus itself at three different sites simultaneously without ...

Oncolys BioPharma & Tacere Therapeutics to develop hepatitis C drug
Pharmaceutical Business Review - USA
By Staff Writer Oncolys BioPharma and Tacere Therapeutics have entered into a strategic alliance to develop hepatitis C drug TT-033.

Direct from the “You go, girl” section of the news ...

FDA Grants Fast Track Status for HCV-796 for Treatment of ...
Earthtimes.org - USA
HCV-796, a unique orally dosed non nucleoside hepatitis C viral polymerase inhibitor that interferes with the replication of hepatitis C virus (HCV), ...

The makers of this potential new inhibitor drug rejects an exclusivity contract with Peg-Intron makers, Schering-Plough.  That’s cool.  Sometimes ya just wanna be able to date other people.

Update on MIGENIX Agreement with Schering-Plough for Hepatitis C ...
PharmaLive.com (press release) - Newtown,PA,USA
The current standard of care for treatment-naive chronic hepatitis C is pegylated interferon combined with ribavirin, which fails to provide a satisfactory ...

... another one bites the dust

XTL stops development of Hepatitis C treatment
Reuters - USA
L: Quote, Profile, Research said on Wednesday it has decided to suspend further development of its XTL-2125 treatment for chronic Hepatitis C, ...

... on the other hand ...

These inhibitor drugs show some promise.  In this first one (fka, VX-950) 72% of the subjects cleared in 12 weeks.  ... Not bad ... so far. On the other hand, we gotta wonder why all the participants opted to continue on the Peg/riba treatment for the full 48 weeks. 

Valopicitabine Combined with Standard of Care Cleared Hepatitis C ...
Earthtimes.org - USA
Valopicitabine is an investigational nucleoside polymerase inhibitor being evaluated in ongoing clinical trials for the treatment of hepatitis C. The most ...

Human Genome Sciences Reports Positive Final Results Of Phase 2b Trial
TransWorldNews (press release) - Monroe,GA,USA
ITT analysis shows that the Albuferon 1200 Q2w treatment group exhibited a robust early antiviral response (reduction in hepatitis C RNA viral load to below ...

Boehringer Ingelheim Initiates SPRING Study Of Aptivus(R ...
Medical News Today (press release) - UK
Extra vigilance is warranted in patients with chronic hepatitis B or Hepatitis C co-infection, as these patients have an increased risk of hepatotoxicity. ..

Human Genome Sciences Reports Positive Final Results Of Phase 2b Trial
TransWorldNews (press release) - Monroe,GA,USA
ITT analysis shows that the Albuferon 1200 Q2w treatment group exhibited a robust early antiviral response (reduction in hepatitis C RNA viral load to below ...

Phynova - Start of US Phase II Clinical Trial for Lead product PYN17
Oxfordshire Bioscience Network (press release) - Oxford,UK
PYN17 is Phynova´s lead candidate for the relief of inflammation and other symptoms suffered by patients with chronic Hepatitis C infection. ...

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