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Author Topic: Biotron starts phase I trial of BIT225, results due June 07!  (Read 3056 times)

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Offline J220

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  • Posts: 587
Biotron starts phase I trial of BIT225, results due June 07!
« on: April 09, 2007, 03:40:33 AM »
From http://www.biotron.com.au/, fingers crossed, as usual!

BIOTRON BEGINS PHASE I CLINICAL TRIAL OF ITS HIV DRUG BIT225

The Directors are pleased to advise that Biotron Limited (‘Biotron’) has initiated a Phase I
clinical trial of BIT225, its lead drug for treatment of HIV. This Phase 1 study is designed to
evaluate the safety and pharmacokinetic properties of BIT225 in humans after a single dose.
BIT225 represents a novel, first in class approach to the treatment of HIV.

BIT225 specifically targets HIV in reservoir cells and represents an opportunity to attack HIV at its
source in the body. Current HIV therapies have little or no effect on HIV in the underlying
reservoir of infected cells where the virus hides from the immune system.

In addition, BIT225 has demonstrated good antiviral activity in surrogate models of Hepatitis
C virus (‘HCV’) infection. This human safety trial of BIT225 will support trials of the drug
in both HIV and HCV infected patients, to commence on conclusion of the Phase I study.

"The initiation of clinical testing of Biotron’s HIV inhibitor is a major milestone for the
Company" said Michelle Miller, Ph.D., Biotron’s Managing Director. "This progression into
human studies marks the transition of Biotron from an R&D focused company to an antiviral
drug development company with an exciting portfolio of clinical development programs”.

The trial is due for completion in the second quarter of 2007.

For further information, please contact Dr Michelle Miller, on (61-2) 61258001.
"Hope is my philosophy
Just needs days in which to be
Love of Life means hope for me
Born on a New Day" - John David

Offline hahaha

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  • Posts: 123
Re: Biotron starts phase I trial of BIT225, results due June 07!
« Reply #1 on: April 13, 2007, 04:41:15 AM »
From http://www.biotron.com.au/, fingers crossed, as usual!

BIOTRON BEGINS PHASE I CLINICAL TRIAL OF ITS HIV DRUG BIT225

The trial is due for completion in the second quarter of 2007.

For further information, please contact Dr Michelle Miller, on (61-2) 61258001.

I believe this is a very important one.  Actually, I think from the very beginning that macrophage is major reservior and carrier , because they can go in between cells and change shape

I do, cross my finger and wish it has a good result.
 
Aug 9, 2006 Get infected in Japan #$%^*
Oct 2006 CD4 239
Nov 2006 CD4 299 VL 60,000
Dec 1, Sustiva, Ziagan and 3TC
Jan 07, CD4 400

Offline Inchlingblue

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Re: Biotron starts phase I trial of BIT225, results due June 07!
« Reply #2 on: December 17, 2009, 11:24:21 AM »
Australian Drug Hope: Biotron Progresses Breakthrough Hiv Treatment Biotron Study Results Reported To Prestigious HIV Conference

MELBOURNE, Australia, 17 December 2009 -There is new hope for HIV positive people around the world, with an international AIDS conference being told that an Australian anti-viral drug in development is able to stop the virus spreading.

The drug, developed by Sydney based company Biotron Limited (ASX: BIT) and known as BIT225 was tested in a study involving 18 HIV positive patients at Sydney’s St Vincent’s Hospital.

Scientists at the Fourth International Workshop on HIV Persistence During Therapy heard the drug was able to inhibit replication of the HIV virus in monocyte cells isolated from the HIV-infected patients, where until now, it has been able to 'hide' from current drug treatments. Monocytes collected from the patients were treated with BIT225 to see the effect of the drug on virus within the cells.

Biotron’s senior virologist Dr John Wilkinson told delegates at the convention that BIT225 was able to stop the virus replicating in these storage cells by up to 99 per cent.

Moreover, it was also able to stop the virus transferring to uninfected T Cells.

“In people infected with HIV there is an ongoing cycle of infection of T Cells with HIV from reservoir cells and, at present, there is no drug that can target this process,” he said.

“Treatment and elimination of this reservoir remains a major therapeutic challenge.

“Even patients who have been treated with highly active anti-retroviral therapy can experience rapid virus rebound because of these virus reserves in reservoir cells.

“By specifically targeting HIV in reservoir cells, Biotron's BIT225 offers the potential to stop this on-going cycle of infection.”

As further international recognition of Biotron's approach to treatment of HIV, a manuscript describing BIT225's ability to inhibit HIV replication in reservoir cells has been published this week in a highly regarded international peer-reviewed scientific journal (1as an electronic version ahead of printed version).

Biotron is now progressing protocols for a Phase Ib/IIa trial of BIT225 in HIV patients. This trial is in addition to the proposed Phase II trial of the same drug in patients infected with Hepatitis C virus (HCV).


LINK:

http://pharmalive.com/News/index.cfm?articleid=673687&categoryid=21

Offline John2038

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Re: Biotron starts phase I trial of BIT225, results due June 07!
« Reply #3 on: December 17, 2009, 12:21:17 PM »
The monocytes are one of potentially many others cells where the virus can hide.
Among them, a recent study have demonstrated that essentially all of the infectious virus particles can bind also to the surface of red blood cells (erythrocytes).

As such, the results obtained with the BIT225 looks like a necessary but unsufficient step toward the purge of all of these latent reservoirs.

Based on that, I don't understand the following sentence (extracted from the link you have provided):

By specifically targeting HIV in reservoir cells, Biotron's BIT225 offers the potential to stop this on-going cycle of infection.”.

I guess and hopes that I have missunderstand something.

Offline sensual1973

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  • Posts: 195
Re: Biotron starts phase I trial of BIT225, results due June 07!
« Reply #4 on: December 17, 2009, 12:39:27 PM »
The trial is due for completion in the second quarter of 2007 ??
« Last Edit: December 17, 2009, 01:22:35 PM by sensual1973 »
God grant me the serenity to accept the things i can not change.

Offline Trout

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  • Posts: 10
Re: Biotron starts phase I trial of BIT225, results due June 07!
« Reply #5 on: December 17, 2009, 03:33:28 PM »
Hi Sensual,

Phase I has already been completed in 2007:

HCV DART conference, December 2007 Maui, Hawaii.
Biotron has announced the successful completion of its first human trial of BIT225. This clinical trial was a Phase 1 study in healthy volunteers. Phase 1 trials are designed to check the safety and tolerability of new drugs, as well as to see if the drug gets into the blood at good enough levels to treat virus infected patients.
As a result of this Phase 1 trial involving 40 volunteers, Biotron now knows that BIT225 appears to be well tolerated and data indicates that they should be able to achieve potentially
therapeutic blood levels of BIT225 in virus infected patients. The next step is to move into clinical trials in virus-infected patients. Two further trials of BIT225 are planned – one in HIV-infected patients and one in HCV-infected patients.


BIT225/HIV Trial
Biotron is now progressing protocols for a Phase Ib/IIa trial of BIT225 in HIV patients.

BIT225/HCV Trial
A Phase Ib/IIa showed interesting results
A landmark human trial of a new treatment for chronic Hepatitis C infection has
shown promising results, with virus levels diminishing in study patients.
An international conference has been told the drug, BIT225, developed by Sydney
company, Biotron Ltd (ASX: BIT), works by targeting the p7 protein, a viral protein
essential to virus production and replication.

A phase II trial of the BIT225 treatment is planned to commence early next year, with
researchers examining how this drug works in combination with current approved
treatments for HCV, Interferon and Ribavirin.


 


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