Shares of InNexus Biotechnology (TSX: V.IXS, Stock Forum) surged more than 33% to 14 cents Wednesday, after the company announced after Tuesday’s market close that the United States Food & Drug Administration has given a positive review of the development plans for InNexus' lead preclinical candidate, DXL625 (CD20) for the prospective treatment of Non-Hodgkin's Lymphoma and/or Chronic Lymphocytic Leukemia.
“At the Pre-IND meeting, FDA supported InNexus' current manufacturing plans stating that the plans were suitable for the manufacture of Phase I product of DXL625 onsite at InNexus. FDA also reviewed completed animal testing and recommended a more expeditious design for the final animal studies to set the stage for human studies. Per these recommendations, InNexus foresees no regulatory impediment to the initiation of human clinical studies in early 2010,” says the company.
The drug development company says its submission included detailed information on plans for a Phase I clinical program, preclinical pharmacology and toxicology data and its current manufacturing.
"We appreciate the thorough review and clear support from FDA for our product development plan. Their review was detailed and comprehensive. As a result, we are particularly pleased that we have affirmation of a clear, simple, and rapid path for DXL625 use in human Phase I trials. Additional pre-clinical testing and analysis will be conducted over the coming months to move us along this path. Results of this additional testing will be provided in our formal IND submission later this year," said Jur Strobos, vice president of clinical & regulatory affairs at InNexus.
On the company’s Bullboard, andy5522 said:
So this means (among other things) that IXS will get the manufacturing exemption if I read this right. From the NR:
" At the Pre-IND meeting, FDA supported InNexus' current manufacturing plans stating that the plans were suitable for the manufacture of Phase I product of DXL625 onsite at InNexus."
The outcome of this meeting (reading the NR) things turned out as well as anybody could possibly have hoped for. Very good news indeed!
NormanVanRodent also noted:
This news is about far more than DXL625, it's also about DXL702, DXL1218, and any other future DXL products. The FDA has looked over the data, and has given us the green light for the manufacturing exemption and a clear path to an IND.
This more than validation of DXL625 - this is validation of the DXL technology itself. This is HUGE. Also remember that DXL702 is about 7 months behind, so this work on 625 paves the way for 702 to potentially be in Phase I late next year.
In 18 months, we could have two clinical stage products in the pipeline (maybe partnered???), many in preclinical (in-house and partnered), and we could be generating revenue through the diagnostics and / or DXL mouse.
