World’s first clinical trial of a domain antibody
SYDNEY, Australia | May 22, 2007 | Biopharmaceutical company, Peptech Limited (ASX: PTD, AIM: PTDx) today announced the commencement of a Phase I trial of its lead compound PN0621, which marks the first administration to humans of a domain antibody derived product. The trial will determine the safety of the compound in up to 30 healthy volunteers and will take place at the St Vincent’s Hospital Clinical Trial Centre in Sydney.
The trial is expected to last for up to four months and the final results, after data analysis and review, should be available in late 2007. The information on safe dosing levels and distribution of the drug throughout the body will be used in the design of Phase II trials of safety and efficacy of PN0621 in the treatment of rheumatoid arthritis and other inflammatory diseases.
Domain antibodies are smaller than conventional antibodies, but retain their important property of participating in highly specific interactions. PN0621 has been tailored for greater potential in reaching parts of the human body that current drugs are not able to reach, potentially resulting in quicker and better treatment of inflammatory diseases.
Patients can develop a resistance to one anti-TNF treatment, but then respond to another, indicating a need for new antibodies, such as PN0621. The Company has already manufactured sufficient quantities of PN0621 for Phase I and Phase II trials.
Sir Greg Winter, a leading pioneer of antibody engineering and an inventor of domain antibodies said: "Peptech have really pushed this product through the development process and it is the first domain antibody-based product to enter into the clinic. It marks a significant milestone in the translation of research to commercial application of this new class of therapeutics.”
Peptech’s CEO, Dr John Chiplin, hailed the Phase I trial as an important milestone for the company. “PN0621 has yielded excellent pre-clinical safety and efficacy data in the lead up to the trial that will establish its safety profile in humans," he said.
The trial participants will each be given a single dose of PN0621 by one of two routes: injection into a vein or under the skin. The first participants will be given the lowest dose. Subject to confirmation of the safety of the lowest dose, subsequent trial participants will be given a higher dose, and so on.
“To date, PN0621 has shown an excellent pre-clinical safety profile and advantages in cost of manufacture compared to full-sized, conventional antibodies. Peptech is now looking forward to gaining the first data from humans as PN0621 progresses through this necessary step towards commercialisation", Dr Chiplin said.
About PN0621:
PN0621 is an anti-TNF, a name given to a class of drugs being developed for the treatment of auto-immune diseases such as rheumatoid arthritis, psoriasis and Crohn’s disease. Auto-immune diseases are indicated where an individual’s immune system mistakenly attacks the body’s own tissues. PN0621 works by blocking the action of TNF (tumour necrosis factor) which is involved in this attack.
Peptech has successfully completed pre-clinical trials of PN0621 where the compound recorded potency levels at least as good as a leading blockbuster anti-TNF drug against rheumatoid arthritis in the same model. The compound was also shown to have optimal design features, making it suitable for commercial production.
Why do we need another anti-TNF drug?
There are currently three anti-TNF drugs on the market, Remicade, Humira and Enbrel. In 2006 these drug had combined global sales of US$10.8 billion, with a projected market value of greater than US$20 billion in 2012. This is a rapidly growing market, which is far from saturated.
It is well documented that patients can develop a resistance to one antibody treatment, but respond to another. The list of indications that can be treated with anti-TNF drugs is increasing to include, asthma, atherosclerosis and atopic dermatitis and there is also a trend developing in diagnosing and treating the inflammatory conditions at a much earlier stage.
About Peptech:
Peptech Limited is a biotechnology company dedicated to developing and providing antibody and peptide-based human therapeutic products for the treatment of cancer and inflammatory diseases.
The Company has tapped its unique antibody technologies and revenues generated from its pioneering anti-TNF patents to build a range of therapeutic assets to address large and clinically validated markets.
Peptech is transitioning to a mid-stage development company as several products move from pre-clinical stages into human trials, starting with the Company’s lead product, PN0621, a differentiated anti-TNF domain antibody construct.
SOURCE: Peptech
Post Views: 136
World’s first clinical trial of a domain antibody
SYDNEY, Australia | May 22, 2007 | Biopharmaceutical company, Peptech Limited (ASX: PTD, AIM: PTDx) today announced the commencement of a Phase I trial of its lead compound PN0621, which marks the first administration to humans of a domain antibody derived product. The trial will determine the safety of the compound in up to 30 healthy volunteers and will take place at the St Vincent’s Hospital Clinical Trial Centre in Sydney.
The trial is expected to last for up to four months and the final results, after data analysis and review, should be available in late 2007. The information on safe dosing levels and distribution of the drug throughout the body will be used in the design of Phase II trials of safety and efficacy of PN0621 in the treatment of rheumatoid arthritis and other inflammatory diseases.
Domain antibodies are smaller than conventional antibodies, but retain their important property of participating in highly specific interactions. PN0621 has been tailored for greater potential in reaching parts of the human body that current drugs are not able to reach, potentially resulting in quicker and better treatment of inflammatory diseases.
Patients can develop a resistance to one anti-TNF treatment, but then respond to another, indicating a need for new antibodies, such as PN0621. The Company has already manufactured sufficient quantities of PN0621 for Phase I and Phase II trials.
Sir Greg Winter, a leading pioneer of antibody engineering and an inventor of domain antibodies said: "Peptech have really pushed this product through the development process and it is the first domain antibody-based product to enter into the clinic. It marks a significant milestone in the translation of research to commercial application of this new class of therapeutics.”
Peptech’s CEO, Dr John Chiplin, hailed the Phase I trial as an important milestone for the company. “PN0621 has yielded excellent pre-clinical safety and efficacy data in the lead up to the trial that will establish its safety profile in humans," he said.
The trial participants will each be given a single dose of PN0621 by one of two routes: injection into a vein or under the skin. The first participants will be given the lowest dose. Subject to confirmation of the safety of the lowest dose, subsequent trial participants will be given a higher dose, and so on.
“To date, PN0621 has shown an excellent pre-clinical safety profile and advantages in cost of manufacture compared to full-sized, conventional antibodies. Peptech is now looking forward to gaining the first data from humans as PN0621 progresses through this necessary step towards commercialisation", Dr Chiplin said.
About PN0621:
PN0621 is an anti-TNF, a name given to a class of drugs being developed for the treatment of auto-immune diseases such as rheumatoid arthritis, psoriasis and Crohn’s disease. Auto-immune diseases are indicated where an individual’s immune system mistakenly attacks the body’s own tissues. PN0621 works by blocking the action of TNF (tumour necrosis factor) which is involved in this attack.
Peptech has successfully completed pre-clinical trials of PN0621 where the compound recorded potency levels at least as good as a leading blockbuster anti-TNF drug against rheumatoid arthritis in the same model. The compound was also shown to have optimal design features, making it suitable for commercial production.
Why do we need another anti-TNF drug?
There are currently three anti-TNF drugs on the market, Remicade, Humira and Enbrel. In 2006 these drug had combined global sales of US$10.8 billion, with a projected market value of greater than US$20 billion in 2012. This is a rapidly growing market, which is far from saturated.
It is well documented that patients can develop a resistance to one antibody treatment, but respond to another. The list of indications that can be treated with anti-TNF drugs is increasing to include, asthma, atherosclerosis and atopic dermatitis and there is also a trend developing in diagnosing and treating the inflammatory conditions at a much earlier stage.
About Peptech:
Peptech Limited is a biotechnology company dedicated to developing and providing antibody and peptide-based human therapeutic products for the treatment of cancer and inflammatory diseases.
The Company has tapped its unique antibody technologies and revenues generated from its pioneering anti-TNF patents to build a range of therapeutic assets to address large and clinically validated markets.
Peptech is transitioning to a mid-stage development company as several products move from pre-clinical stages into human trials, starting with the Company’s lead product, PN0621, a differentiated anti-TNF domain antibody construct.
SOURCE: Peptech
Post Views: 136
