Date: 2012-07-03
Type of information:
phase: 2
Announcement: results
Company: Diamyd Medical (Sweden)
Product: NP2 Enkephalin
Action mechanism: Gene therapy - NTDDS (Nerve Targeting Drug Delivery System) represents a new class of pharmaceutical products that delivers gene-based drugs directly to nerve cells, providing a direct effect in the cells targeted by the treatment. The drug candidate NP2 Enkephalin has been engineered to deliver the human Enkephalin gene, which naturally produces opioid peptides involved in pain control, directly to the site of pain in the nervous system.
Disease: cancer pain
Therapeutic area: Cancer - Oncology - CNS diseases
Country: USA
Trial
details: The study includes a total of 33 adult subjects, 17 randomized to receive NP2 Enkephalin and 16 randomized to the placebo group. It is being conducted at 18 clinics in the United States. The purpose of the randomized, double-blind, and placebo-controlled Phase II study is to evaluate the effect of intradermal injection of NP2 Enkephalin on pain reported by subjects suffering from severe intractable pain due to cancer, as well as to confirm the safety of the treatment.
There is a four-week, double-blind study period where the subjects’ pain scores are being monitored and recorded. After the four week blinded study period all patients are offered up to two doses of active NP2 Enkephalin in an unblinded study extension. The follow-up will collect pain scores following repeat dosing as well as provide additional safety data. It is the first sizeable and placebo-controlled clinical trial of a drug candidate based on Diamyd Medical’s patented Nerve Targeting Drug Delivery System, a unique technology for delivery of therapeutics directly to the nervous system. (NCT01291901)
Latest
news: * On July 3, 2012, Diamyd Medical has reported results from a Phase II study evaluating its drug candidate NP2 Enkephalin in cancer pain. The study did not meet its primary objective of reducing pain in subjects with severe intractable cancer pain. An initial analysis of the results from the 28 day double-blind main study period shows that during day 3 to 14 following a single dose of study drug, the group that received NP2 Enkephalin reported on average no better improvement in pain score than the placebo treated group. Pain scores are reported daily by the study subjects applying a numerical rating scale from 0 to 10.
The treatment has been well tolerated, as demonstrated by a comparable number of serious adverse events in the two treatment groups, and the fact that no serious adverse events have been deemed related to the treatment. Data continues to be collected from an open label extension period of the study where subjects have received up to two additional doses of NP2 Enkephalin. All the subjects also receive conventional pain therapy throughout the study, including opiate drugs. The company will continue the analysis of this study, including subgroups and the data from the open label extension period, to determine how to adapt the development plan for our NTDDS portfolio of drug candidates addressing diseases and symptoms within the nervous system which today cannot be adequately treated. The study has been iniated on February 2011.
* On February 10, 2011, Diamyd has announced the initiation of the Phase II multi-center, randomized, double-blind, placebo controlled clinical trial with the candidate drug NP2 Enkephalin. The study is designed to provide an evaluation of the safety and effect of NP2 Enkephalin with regards to pain relief, other pain medication usage and quality of life. The trial has a four week double-blind main study period and an open label study extension wherein all patients will be offered up to two additional doses of active NP2 Enkephalin.
The trial finalization date has preliminary been set to one year from start date on ClinicalTrials.gov. .
