PEPTECH’S 1ST DOMAIN ANTIBODY IN HUMANS ‘TOLERATED’
October 29th 2007 20:42
Biotech Daily
Monday October 29, 2007
Daily news on ASX-listed biotechnology companies
Monday October 29, 2007
Daily news on ASX-listed biotechnology companies
* ASX, BIOTECHS UP: SUNSHINE HEART UP 10%, PORTLAND DOWN 7%
* PEPTECH’S 1ST DOMAIN ANTIBODY IN HUMANS TOLERATED
* CHEMGENEX SPINS OUT DIABETES RESEARCH
* EDITORIAL: DIRECTORS’ FEES AND FINANCIAL REPORTING, REVISITED
* BIOLAYER AND ALZYHME DEVELOP ALZHEIMER’S TEST
* XITRON GIVES IMPEDIMED SAN DIEGO BASE, ‘CORNERSTONE’ IP
* UK APPROVES SECOND NEURODISCOVERY’S NSL-043 PHASE I TRIAL
* CHINA ACCEPTS HELICON’S RECELL MARKETING APPLICATION.
* DISSENT AT NOVOGEN AGM OVER EXECUTIVE OPTIONS
* XCEED AGM TO CHANGE NAME; APPOINT DIRECTORS
* LIVING CELL EXTENDS TRADING HALT TO SUSPENSION
* CYTOPIA APPOINTS GAVAN FLOWER CFO
* ANTISENSE APPOINTS KATE PLUMRIDGE JOINT COMPANY SECRETARY
THE MARKET
Twenty of the Biotech Daily Top 40 stocks were up, 15 stocks fell, three traded unchanged and two were untraded.
Sunshine Heart was best, up 1.5 cents or 9.68 percent to 17 cents with 176,001 shares traded, followed by Polartechnics up 3.5 cents or 8.64 percent to 44 cents and Sirtex up 38 cents or 8.23 percent to $5.00.
Portland led the falls down 1.5 cents or 7.32 percent to 19 cents with 53,650 shares traded followed by Peplin and Starpharma down more than six percent.
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PEPTECH
Peptech’s phase I trial of PN0621 for rheumatoid arthritis showed the drug was well-tolerated and the compound will progress to phase II trials by mid-2008.
Data from the trial completed in 30 healthy volunteers showed that ascending single doses of PN0621 administered intravenously and subcutaneously were well-tolerated.
Peptech said the trial involved the first administration to humans of a domain antibody derived product.
PN0621 was developed for Peptech by Domantis, which is now part of Glaxosmithkline.
The phase II program will examine the safety and efficacy of PN0621 in the treatment of rheumatoid arthritis and other inflammatory diseases.
These trials are expected to commence in the first half of 2008. The company has manufactured sufficient quantities of PN0621 to proceed to phase II trials.
Peptech chief executive officer Dr John Chiplin said PN0621 had passed its first clinical milestone.
“This is a great result both for the company and for those suffering from inflammatory disease,” Dr Chiplin said.
“We look forward to moving from healthy volunteers to treating patients as we progress the clinical testing of this new generation treatment,” Dr Chiplin said.
Peptech said PN0621 was based on a domain antibody, tailored to be smaller than a conventional antibody while retaining similar properties in terms of capacity to bind to other molecules.
This design is expected to provide advantages over existing antibody therapies in the treatment of inflammatory diseases.
The company said there was a need for new treatments for severe rheumatoid arthritis because some patients develop resistance to prolonged treatment yet respond when switched to an alternate antibody therapy.
The phase I trial participants each received a single dose of PN0621 by one of two routes: injection into a vein or under the skin.
Starting at a low dose, levels were increased until the predicted therapeutic dose level was exceeded. Clinical data indicates dosing at all levels was well tolerated.
“The clinical safety data, taken together with PN0621’s excellent pre-clinical safety profile and advantages in cost of manufacture, place PN0621 in an excellent position,” Dr Chiplin said.
“We can now focus on demonstrating PN0621’s efficacy in treating diseases and look to capitalize on the product’s advantages due to its smaller size compared to full-sized, conventional antibodies," Dr Chiplin said.
Peptech said PN0621 was an anti-tumor necrosis factor drug, 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 occur when an individual’s immune system mistakenly attacks the body’s own tissues. PN0621 works by blocking the action of tumor 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 also shows good potential for cost competitive commercial production with high levels of production and yield of purified material.
There are three anti-TNF drugs on the market, Remicade, Humira and Enbrel. In 2006 these drug had combined global sales of $US10.8 billion.
Peptech was up three cents or 2.63 percent to $1.17.
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