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Author Topic: Biotron's BIT225 can clear out HIV reservoir pools  (Read 3356 times)

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Offline Tadeys

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  • Posts: 162
Biotron's BIT225 can clear out HIV reservoir pools
« on: December 05, 2013, 03:06:27 PM »
Biotron (ASX:BIT) has published new results from a phase Ib/IIa HIV study suggesting that its lead drug candidate BIT225 can reduce the quantity of virus in HIV reservoir cells.
The company has already published results suggesting that BIT225 can target HIV replication in these monocyte lineage reservoir cells.
The response was greatest in patients with higher total HIV-1 DNA at baseline. As expected, no changes in viral load were observed during the brief treatment period.
The new data were presented by Biotron’s senior virologist Dr John Wilkinson at the Sixth International Workshop on HIV Persistence during Therapy, being held this week in Florida.
The placebo-controlled, randomised study involved 21 patients with HIV-1 infection, of which 14 received BIT225 and the rest a placebo. Patients were dosed over a 10-day period; blood was collected three times during dosing and once during a follow-up visit at day 20.
“The latest results show that BIT225 is able to clear out underlying virus pools from these reservoir cells,” Biotron Managing Director Dr Michelle Miller said.
She said this suggests that the compound could potentially help break the cycle of infection and reinfection with HIV if incorporated into treatment regimens for the virus.


Offline Matts

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Re: Biotron's BIT225 can clear out HIV reservoir pools
« Reply #1 on: October 11, 2014, 03:18:01 PM »
BIT225 can cure HCV:



Biotron achieves sustained virologic response (SVR12) in 100% of hepatitis C virus genotype 3 patients in an open label HIV/HCV genotype 3 trial of BIT225
Sydney, Australia, 10 October 2014
 Australian drug development company Biotron Limited (ASX:BIT) today announced that all Hepatitis C virus (HCV) genotype 3 (G3) patients completing a key Phase 2 trial of its lead antiviral drug, BIT225, have undetectable levels of HCV 12 weeks after ceasing all treatment. 
The endpoint of HCV treatment is a sustained virologic response (SVR).  Sustained virologic response at week 12 (SVR12) is defined as an undetectable HCV RNA level 12 weeks after completion of treatment.  It is considered to be a prediction of permanent clearance of the virus and, effectively, a cure. 
These findings extend previous data that showed that these patients had undetectable HCV at earlier stages during the treatment period. 
Under the protocol of this open label pilot study (BIT225-006) undertaken at a single trial site in Bangkok, Thailand, 8 patients co-infected with HIV and HCV G3 received standard of care HCV drugs interferon and ribavirin (IFN/RBV) for 7 days before commencing treatment with BIT225.  They then received 300 mg BIT225 twice daily plus IFN/RBV for 28 days.  After that time, patients continued to take IFN/RBV until week 48, at which time all treatment was stopped (as per standard treatment guidelines). 
The primary objectives of the trial were the assessment of safety and tolerability.  Secondary objectives of assessment were of pharmacokinetics and antiviral efficacy. 
Of the eight HCV G3 patients enrolled in the trial, three withdrew during the first 12 weeks of the study due to intolerance of the treatment with IFN/RBV.  The remaining five completed their full course of treatment and had undetectable levels of HCV from week 12 of dosing.  Virus levels continued to be undetected at week 24 and at week 48, when all treatment ceased.  At week 60, which is 12 weeks after stopping treatment, all remain clear of virus (SVR).  The SVR rate for IFN/RBV alone in HCV G3 patients in Thailand is 68.8%.  Although the number of patients in the trial is small, the fact that 100% had no HCV detected from week 12 onwards is encouraging evidence of efficacy of BIT225.
In addition, it has been shown that the rate of reduction in virus levels was accelerated once BIT225 was added to the IFN/RBV treatment at day 7. 
Detailed analyses and reviews of safety and pharmacokinetic data from the trial are in progress. 
Biotron Managing Director Dr Michelle Miller commented; "These SVR12 data support the efficacy of BIT225 as a potential new therapy for HCV and, in particular, for this difficult to treat group of HIV/HCV co-infected patients who typically have more serious HCV infection and fewer treatment options." 
In vitro assays have shown that BIT225 has pan-genotypic activity.  Previous clinical trials of BIT225 have focused on patients infected with the genotype 1 variant of the virus, which is the most common genotype in Western populations.  These data further extend the Company's clinical data portfolio to include genotype 3, which is endemic in Southeast Asia. 
A three-month dosing Phase 2, placebo controlled, double-blinded trial of BIT225 in combination with IFN/RBV in HCV genotype 1 (n=30) and genotype 3 (n=30) patients is currently in progress.  Preliminary results are expected before the end of 2014. 
Dr Miller further commented; "Both HIV and HCV viruses present substantial challenges for treatment and represent multi-billion dollar markets.  We look forward to progressing commercialisation of BIT225 as a valuable new therapy that will work in combination with current and future treatment strategies." 
Yours sincerely 
Peter J. Nightingale Company Secretary 

Enquiries Dr Michelle Miller   Rudi Michelson Managing Director   Monsoon Communications Biotron Limited   +61-3 9620 3333 +61-(0)412313329

About Biotron and BIT225
Biotron Limited is engaged in the research, development, and commercialisation of drugs targeting significant viral diseases with unmet medical need, with a major focus on HIV and HCV.  The Company has BIT225 in clinical development for both HIV and HCV, and also has several earlier stage preclinical and research programs for several other viral infections including Dengue. 
BIT225 has recorded encouraging data against HCV in clinical trials.  A phase 2a trial in HCV demonstrated that 100% of HCV genotype 1 infected patients receiving BIT225 (400 mg) in combination with current standard of care therapies interferon and ribavirin had undetectable virus after 48 weeks. 
BIT225 is also in development for treatment of HIV, and is the first in a new class of antiviral drugs that may provide a new approach to eradication of this virus.  It has shown clinical efficacy against HIV in reservoir cells, and has the potential to be combined with new or existing anti-retroviral drugs to eradicate long-lived pools of virus that are not eliminated with current treatments. "

Offline buginme2

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Re: Biotron's BIT225 can clear out HIV reservoir pools
« Reply #2 on: October 11, 2014, 03:36:50 PM »
Do people actually read the articles they post, beyond the headline?

This article amounts to a big so what
Don't be fancy, just get dancey

Offline Matts

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  • Posts: 269
Re: Biotron's BIT225 can clear out HIV reservoir pools
« Reply #3 on: October 11, 2014, 04:25:34 PM »
I hope that Biotron's BIT225 doesnt go the same way like Sofosbuvir- developed by a small company and bought from a major player, the rest is known.
Biotron shares have jumped up 75%, the game can begin.
Maybe and only maybe  Bit 225 can cure HIV, Dengue fever and other viral diseases in the future. The story could get interesting. :)

Offline Dr.Strangelove

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Re: Biotron's BIT225 can clear out HIV reservoir pools
« Reply #4 on: October 11, 2014, 04:28:43 PM »
I'm not going to comment on the HCV aspect, but I'm very skeptic about the claim that BIT225 can clear out HIV reservoirs. Not that I doubt it works in interrupting the HIV replication cycle in monocytes, which is off reach of current HIV drugs. But that's not the same as clearing out the latent cells - it's rather making sure no new latent cells of that type are being created. But as we know the provirus can remain dormant for many many years and BIT225 doesn't change anything about that because it doesn't 'wake up' latent cells. So, I don't see this as a game changer.

Offline buginme2

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Re: Biotron's BIT225 can clear out HIV reservoir pools
« Reply #5 on: October 11, 2014, 04:43:36 PM »
Ok wait.


This news article that says "BIT225 can clear out hiv reservoirs."

Yet, no where in the article or any other article does it show this to be true.  The article doesn't even talk about it.  The article goes on to discuss an hcv clinical trial that in no way is even related.  The only mention of hiv is that some people with hiv are coinfected.with hcv.

It appears the entire article was written with the sole intention of crafting a false buzz to increase the share price of the companies stock, which is a penny stock at that.

Honestly,I wish people wouldn't post this crap.

« Last Edit: October 11, 2014, 04:49:45 PM by buginme2 »
Don't be fancy, just get dancey

Offline geobee

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  • Posts: 351
Re: Biotron's BIT225 can clear out HIV reservoir pools
« Reply #6 on: October 11, 2014, 05:18:48 PM »
Ditto re: the headline is a total fabrication and feeling a little duped.  It would be cool, to, if they have another HCV drug.  Give Gilead's $1200 USD per pill some competition.


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