Posts Tagged ‘Phase II trials’

CBio Achieves Arthritis Treatment Milestone

Friday, March 12th, 2010

Australian drug development company CBio Limited (CBZ) announced the achievement of a clinical trial milestone under its option agreement with global pharmaceutical leader Novo Nordisk A/S. The agreement relates to the development of XToll, the potential new-generation drug therapy which could provide safer and more effective treatment of autoimmune diseases such as rheumatoid arthritis (RA).

The clinical trial milestone was triggered by the recruitment of the 75th patient into the current 150 patient phase II clinical trial.  “We remain greatly encouraged by progress in the trial and feedback from clinical investigators, and are focussed on completing the trial and receiving the final results,” said CBio Managing Director Jason Yeates.

“We believe that CBio holds an attractive pharmaceutical asset in XToll and that the drug has the potential to address the unmet needs of patients and participate in what is currently a US$17 billion global market,” Mr Yeates said.  “Many patients are only partial responders to existing therapies and adverse effects from these therapies are a real issue being faced by RA patients every day. Safer and more effective treatments are needed,” he said.

Under the terms of the agreement, Novo Nordisk will make a milestone payment to CBio of US$1 million.  The agreement was signed in May 2008 and grants Novo Nordisk an exclusive option to negotiate an exclusive licence to CBio’s intellectual property surrounding XToll which is currently in phase II clinical trials at sites across Australia and New Zealand. Additional clinical trial sites in Serbia, Bosnia and Georgia are expected to commence recruitment this month.

www.cbio.com.au

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Peplin Successfully Completes Phase II Trials

Tuesday, May 19th, 2009

Peplin, Inc. (PLI) today announced positive results for PEP005 (ingenol mebutate) Gel in REGION-I, its Australian and US based Phase III actinic (solar) keratosis (AK) clinical trial for the treatment of lesions on non-head locations, which include the trunk and extremities.  AK is a common pre-cancerous skin condition caused by sun exposure, which can develop into skin cancers if left untreated. Options for solar keratosis have a number of shortfalls, including pain, persisting skin irritation and redness during prolonged treatment periods. As a result, patients are often unwilling to use their medications. A topical agent like PEP005 Gel, which can effectively and conveniently treat lesions in two days, will be of significant benefit to doctors and their patients. As seen in previous non-head trials, the local skin responses (LSRs) peaked at Day 8 and returned to baseline by Day 29.  The most frequent LSRs included erythema, flaking and scaling with no significant adverse effects reported.  Peplin will conduct its End-of-Phase II meeting with the FDA on June 3, 2009. 

Peplin’s Chief Executive Officer, Tom Wiggans, is pleased with the positive results and said: “These strong results achieve an important step towards commercialisation.  In addition, they confirm efficacy signals with prior trials and market need, since no currently marketed product has proven efficacy for this range of locations for non-head lesions, especially with a 2-day course of therapy.  PEP005 Gel continues to provide patients the potential for a compelling alternative”. 

Peplin is a development stage specialty pharmaceutical company focused on advancing and commercialising innovative medical dermatology products. Peplin’s lead product candidate is a patient-applied topical gel containing ingenol mebutate, a compound the use of which Peplin has patented for the treatment of actinic (solar) keratosis, or AK. This product candidate referred to as PEP005 (ingenol mebutate) Gel is currently in Phase III clinical trials, having just completed their first Phase III, known as REGION-I. 

www.peplin.com

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