Press Release: Shionogi-GlaxoKlinePharmaceuticals Acknowledges Position of the EATG and the ATAC toRevise Protocol for ING112276, a Clinical Study for S/GSK1349572]

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Press Release: Shionogi-GlaxoKline

Pharmaceuticals Acknowledges Position of the EATG and the ATAC to

Revise Protocol for ING112276, a Clinical Study for S/GSK1349572

Data:

Thu, 13 Aug 2009 13:59:08 +0200

De:

Ana Lúcia Cardoso <analucia.cardoso@...>

Para:

Ana Lúcia Cardoso <analucia.cardoso@...>

FOR IMMEDIATE RELEASE:

Shionogi-GlaxoKline

Pharmaceuticals Acknowledges Position of the European AIDS Treatment

Group and

the AIDS Treatment Activists Coalition to Revise Protocol for

ING112276, a

Clinical Study for S/GSK1349572

Issued:

Thursday, 13 August 2009

- London, UK, Brussels, Belgium and New York, NY

Shionogi-GlaxoKline

Pharmaceuticals, LLC, in collaboration with the European AIDS Treatment

Group

(EATG) and the Drug

Development Committee (DDC) of the AIDS Treatment Activists

Coalition (ATAC), today announces plans to revise

inclusion criteria for Study

ING112276. The ING112276 study is a dose-ranging study of the

investigational

integrase inhibitor S/GSK1349572 in antiretroviral therapy-naïve

patients.

In

response to evolving regulatory recommendations and HIV community

consensus on

the appropriate patients to include in dose-ranging studies of

investigational

agents, the amendment increases the minimum allowable CD4+ cell count

to 200

cells/mm3 (or higher as local guidelines dictate). Patients with

lower CD4+

counts should be treated with established standard of care agents, as

their

immediate need for therapy is greater.

“Working

together, we are able to draw upon the collective

expertise of the HIV community, patients, clinicians, researchers and

regulatory agencies to develop new medicines for the treatment of

people living

with HIV and AIDS,” commented Dr. Garrett Nichols, Co-Project Leader

for

the clinical development of S/GSK1349572, Shionogi-GlaxoKline

Pharmaceuticals, LLC. “Though the original protocol inclusion criteria

were aligned with current practices and precedents and agreed with the

appropriate regulatory and ethical review boards, the additional

perspectives

offered by the HIV community are important in this rapidly evolving

field. We

are pleased to acknowledge the positions of the EATG and DDC on this

issue.”

He

continued, “It is important to stress that the rationale for this

change

is not based upon any new data or safety concern for S/GSK1349572

specifically,

or integrase inhibitors in general. Rather, we are committed to

focusing on

the needs of the broader HIV community, thereby prioritizing patients

in all of

our work.”

Implemented

in June 2009, the EMEA Guidelines on the Clinical Development of

Medicinal

Products for the Treatment of HIV Infection1 for exploratory

studies

in HIV-infected individuals state that treatment-naïve patients in need

of

immediate therapy under current guidelines (i.e. those with CD4+ T-cell

count

below about 200 cells/mm3 or symptomatic patients) should be

included in exploratory studies only if there is a scientific rationale

and if

data are available from patients with higher T-cell counts. Due to the

importance of first-line therapy in these patients, appropriate

antiretroviral

activity should be documented. Therefore, the use of an experimental

compound

in suboptimal doses, dose intervals, or combinations, should be

excluded with

reasonable certainty prior to beginning studies in these patients.

“The EATG

supports this position and

believes there is a need for review and broader application of the

European

regulatory guidelines with respect to enrollment of treatment-naïve

patients

into clinical trials,” stated Wim Vandevelde, Chair, European Community

Advisory Board. “We are pleased that GSK has listened to the concerns

of

the EATG and is taking a leadership position in the context of the

varied

interpretation of the existing guidelines. It is imperative that

people with

immediate need of initiating antiretroviral treatment are able to

receive the

optimal standard of care. The

EATG calls for greater involvement of the

HIV community in regulatory review panels at the regional and national

level.”

"Having

pharmaceutical

companies listen to and incorporate the concerns of AIDS activists is

critical

to designing safe and effective trials of HIV drugs,” said ,

Co-chair of the DDC. “This is a good example of how that process can

and

should work. Activists have never sought to unnecessarily slow down

drug

development, only to promote the well-being of those who volunteer for

the

studies. That will be accomplished with this protocol amendment, and

we are

pleased that GSK is equally committed to prioritizing patients."

The

undersigned groups call for further

stakeholder discussion to review and agree definitive guidelines for

recruitment of antiretroviral-naïve patients in dose-ranging trials of

investigational

agents, while simultaneously encouraging the pursuit of urgently needed

new and

innovative medicines for the treatment of HIV and AIDS.

-ends-

About

Integrase Inhibitors

Integrase

inhibitors are a new class of

anti-HIV drugs that blocks HIV replication by preventing viral DNA from

integrating into the genetic material of human immune cells (T-cells).

This

step is essential in the HIV-1 replication cycle. Integrase inhibitors

are of

great interest because they have a different mechanism of action than

other

anti-HIV drugs, and there is a need for new medications that help

address

resistance issues and provide additional treatment options. Patients

need

multiple, active antiretroviral drugs that can be administered in

combination

to attain viral suppression, as well as new drugs that

offer different resistance profiles and simplified dosing.

About

European AIDS Treatment Group

Established

in 1992, the European AIDS Treatment Group (EATG) is a European network

of

nationally-based activists. As a European patient-led advocacy

organization,

it has been at the forefront of the development of the civil society

response

to the HIV/AIDS epidemic in Europe. It represents and defends the

treatment-related interests of people living with HIV and AIDS. One of

its

working groups, the European Community Advisory Board (ECAB) aims to

promote

the harmonization of the best available clinical practices, standards

of care

and access to the latest and best available therapies and diagnostic

tools

throughout Europe, with a particular regard to Central and Eastern

Europe.

About

AIDS Treatment Activists Coalition

The

AIDS Treatment Activists

Coalition (ATAC) is a national coalition of AIDS activists, many living

with

HIV/AIDS, working together to end the AIDS epidemic by advancing

research on

HIV/AIDS. ATAC's Drug Development Committee (DDC) works with

government,

academia and the pharmaceutical industry to provide a community

perspective

into the development of new HIV drugs and the utilization of HIV

therapies.

About

Shionogi-GlaxoKline

Pharmaceuticals, LLC

Shionogi-GlaxoKline

Pharmaceuticals, LLC

is a long-standing joint venture between Shionogi & Co., Ltd. and

GlaxoKline (GSK) which has made considerable progress in

developing

next-generation integrase inhibitors for the treatment of HIV.

Launched in

2001, the joint venture was originally established for the development

and

commercialization of new agents to fight HIV and neurological

disorders,

including Alzheimer’s, stroke, and head injury. More recently, the

company has focused exclusively on several new integrase inhibitor

candidates

jointly discovered by Shionogi & Co., Ltd. and GSK.

European

AIDS Treatment Group Contact:

Nikos

Dedes +306 944 386 560

nikos.dedes@...

AIDS

Treatment Activists Coalition Contact:

Jeff

Berry +1 773 454

5333 jeffberry@...

GlaxoKline

Contacts:

Purdon – Director, Patient Relations

+44

208 047 4716 scott.d.purdon@...

Marc

Meachem – Director, Product Communications

+1

919 483 8756 marc.s.meachem@...

Robin

Fastenau –

Director,

Global Pipeline Communications

+1

919 483 7966 robin.e.fastenau@...

Ana Lúcia Cardoso

Programme

Assistant

European

Aids

Treatment Group (EATG)

Place

Blyckaerts 13

B-1050

Brussels, Belgium

Tel.

(Secretariat): +32 2 626 96

40

Direct

line: +32 2 626 96 42

Fax: +32 2

644 33 07

analucia.cardoso@...

Please

visit us at www.eatg.org

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