Alongside the Phase II evidence of safety and efficacy in glioblastoma, Activartis has evidence from academic clinical trials demonstrating the technology is applicable to other tumor types

For now, the bulk of clinical trials targeting epigenetic mechanisms is still at an early stage...Those clinical trials, he said, will be "the ultimate test of the whole hypothesis

For now, the bulk of clinical trials targeting epigenetic mechanisms is still at an early stage...Those clinical trials, he said, will be "the ultimate test of the whole hypothesis

RN-307 was discovered and originally developed by Rinat Neuroscience Corp., a South San Francisco protein therapeutics company that was acquired by Pfizer in 2006. (See BioWorld Today, April 10, 2006.) In a Series C financing Versartis Inc., of Redwood City, Calif., raised $25 million to support clinical trials of its product candidate VRS-317 for growth hormone deficiency in children. (See BioWorld Today, Jan. 16, 2013.) The drug is a once-monthly form of recombinant human growth hormone (HGH

The complex asset contribution agreement involves multiple transfers of common stock and warrants, along with patents, regulatory filings and investigational new drug (IND) applications filed with the FDA for Geron's Phase I safety study of oligodendrocyte progenitor (GRNOPC-1) cells in patients with neurologically complete, subacute spinal cord injury – the first FDA-approved ESC clinical trial. (See BioWorld Today, Jan. 26, 2009, and Jan. 27, 2009.) The S-1 represented the first step to

Net proceeds will be used to cover costs related to the new drug application for CompleoTRT, making a milestone payment for CompleoTRT, manufacturing scale-up for CompleoTRT and Tefina clinical trials

Jose Baselga, physician-in-chief at Memorial Sloan-Kettering Cancer Center and the chairman of the program committee for the 2013 annual meeting, said in a recorded greeting that the data being presented at the conference span the trajectory from basic biology to clinical trial results

Haynes and his colleagues said they hope that by understanding the road traveled by the broadly neutralizing antibody their subject produced, they will be able to develop a series of antigens that can be used to induce broadly neutralizing antibodies via a series of vaccinations – though Haynes' response when asked when such a vaccine might enter clinical trials was succinct: "I don't know

Intended as a conversation starter, the draft lays out a potential approach to select subjects with early AD and those at risk of developing the disease for enrollment in clinical trials...According to the guidance, the FDA can't formally endorse specific diagnostic frameworks yet because of "the need for an assessment of sensitivity and specificity in identifying patients who do have actual AD in clinical trials

2DG is already in clinical trials for some types of cancer, and we think that it might provide a way to interfere with the progression of this disease

Themis Bioscience GmbH is planning to begin clinical trials of viral vaccine candidates to protect against dengue virus and chikungunya virus infections before year-end, following successful preclinical proof of concept studies

Anaeropharma Science Inc., of Tokyo, initiated a Phase I trial of APS001F in U.S. patients with advanced or metastatic solid tumors whose disease is no longer responsive to available treatments. The dose-escalation trial is designed to evaluate the safety, tolerability and efficacy of APS001F, a living recombinant bifidobacterium designed to express the cytosine deaminase gene in tumors. The therapy is expected to limit the systemic toxicity of the antitumor agent 5-FU. Convergence

He estimated that such clinical trials are five years away at least

Tengion Inc., of Winston-Salem, N.C., said the firm's clinical trial application was accepted in Sweden to start a Phase I trial testing its Neo-Kidney Augment in up to five patients with advanced chronic kidney disease

Separately, BioMarin said it submitted a clinical trial application with the UK's Medicines and Healthcare Products Regulatory Agency for BMN-190, a recombinant human tripeptidyl peptidase 1 , in neuronal ceroid lipofuscinosis Type 2 (NCL-2), a form of Batten disease

The next step "is to get data from the clinical trial," he added

In response, the FDA's Center for Drug Evaluation and Research issued draft guidance in February on the development of drugs in early stage Alzheimer's disease, which lays out a potential approach to select subjects with early AD and those at risk of developing the disease for enrollment into clinical trials

Intended as a conversation starter, the draft lays out a potential approach to select subjects with early AD and those at risk of developing the disease for enrollment in clinical trials...According to the guidance, the FDA can't formally endorse specific diagnostic frameworks yet because of "the need for an assessment of sensitivity and specificity in identifying patients who do have actual AD in clinical trials

Themis Bioscience GmbH is planning to begin clinical trials of viral vaccine candidates to protect against Dengue virus and Chikungunya virus infections before year-end, following successful preclinical proof of concept studies