Amkor Pharma, Inc. Stroke Drug Nears End Of Phase I Clinical Studies, Prepares For Phase II In 2008
To date, the Company has enrolled 95 subjects in this phase 1 study and expects to enroll the remaining seven subjects comprising the final cohort during the next two months. The study was originally planned as a two part single bolus study split between 64 young volunteers (in eight cohorts) and 24 elderly volunteers over the age of 65 (in three cohorts). Earlier this year, when the healthy, young cohorts did not show any dose-limiting toxicity, a third set of volunteers (in two cohorts) was added by Amkor to further extend dosing, to allow an option for administering higher levels over longer periods of time in future phase II studies and enhance the ability to show significant efficacy in those studies. The three parts of the phase I study are now referred to as follows: phase Ia (single bolus young volunteers); phase Ib (extended dosing young volunteers); and phase Ic (elderly volunteers).
Once a final report has been received on currently enrolled subjects, the Company will have reached an important milestone in the clinical development of Neu2000KL. Specifically, the Company will have demonstrated that it can safely administer Neu2000KL at doses which, based upon animal studies, it believes are sufficient to support advancement into phase IIa studies for both sudden cardiac arrest and ischemic stroke at clinically relevant doses.
Reaching the above mentioned milestone will allow the Company to focus its efforts on preparation for phase IIa studies, which includes completion of certain manufacturing and preclinical requirements associated with entry into phase II studies.
The completed phase Ia portion of the study was a placebo-controlled, blinded study that involved 64 healthy volunteers below the age of 65 years, who were grouped into eight cohorts of eight subjects. Each cohort contained six treated subjects and two placebo subjects. All treated members of a cohort received the same drug dosage, with drug dosage escalating through the eight cohorts from 10 mg to 1500 mg, given as a single intravenous bolus injection over fifteen minutes. Data from each cohort remained blinded throughout the conduct of the phase Ia portion of the study.
The drug was well tolerated at all doses tested during phase Ia. No serious adverse events (SAEs) were seen during the phase Ia. Adverse events (AEs) were primarily mild, were not dose-related and were not considered to be drug related. The single moderate AE seen in phase Ia was a liver enzyme elevation seen at day three following administration. This enzyme was not elevated at any time points earlier than day three, nor after day three, and is not thought to be drug related. The most common AEs, each of which was seen at a frequency of less than 15% in treated patients, were tachycardia, dizziness upon standing, headache, bleeding at blood draw site, cold feeling, nausea, hypotension upon standing. Other AEs occurred at a frequency of 4% or less, and are not considered to be drug related.
The phase Ib study of Neu2000KL has completed enrollment and Amkor expects to unblind the data during the first quarter of 2008. No SAEs were seen among these two cohorts and most AEs were graded as mild. This portion of the study, involving two cohorts of eight subjects each, successfully extended drug dose levels to 6000 mg, administered over a period of up to 4.25 hours. This portion of the study was conducted using the same design and with the same subject population as the phase Ia portion.
The phase Ic portion of the study has completed enrollment of the first and second cohorts of volunteers, using a similar study design as phase Ib, but using volunteers 65 years of age and older. Enrollment of the third and final cohort is expected to complete during the first quarter of 2008, and will position Amkor Pharma to advance Neu2000KL toward a phase 2 study during 2008.
Dr. Robert T. Abbott, President and CEO of Amkor, said, "We are very gratified by the safety profile shown by this drug. Numerous other NMDA antagonists have been plagued by unacceptable side effects, so the apparent safety of Neu2000KL could be a major step forward in the field. In addition, this benign profile has allowed us to safely administer the drug to subjects at doses well in excess of those showing significant efficacy in animal models. We look forward with anticipation to advancing this product into phase 2 studies during the next year."
Amkor Pharma, Inc. is a clinical-stage company located in Seattle, Washington, USA, focused on the development of drugs to treat tissue injury. Its principle efforts are currently directed at advancing Neu2000KL through phase 2 clinical studies in ischemic stroke and sudden cardiac arrest. Amkor Pharma is majority owned by Neurotech Pharmaceuticals, Inc.
Neurotech is a South Korean pharmaceutical company which discovers and develops small molecule therapeutics to treat neurological diseases. The company is located in Suwon, Korea.
Amkor Pharma, Inc.
Amkor Pharma, Inc Cursa de droguri Nears Sfârºitul Studii clinice de fazã I, se pregãteºte pentru faza a II-În 2008 - Amkor Pharma, Inc. Stroke Drug Nears End Of Phase I Clinical Studies, Prepares For Phase II In 2008 - articole medicale engleza - startsanatate