Clinical Intelligence

FDA approves LialdaR

Wednesday, July 20, 2011 11:13 AM

Shire, a global biopharmaceutical company, reported the FDA approved LialdaR (mesalamine) Delayed Release Tablets for the maintenance of remission in patients with ulcerative colitis. This approval is based on results from a six-month study demonstrating the safety and effectiveness of Lialda in maintaining endoscopic remission in adult patients. This approval follows the previous indication of Lialda approved by the FDA in 2007 for the induction of remission in patients with active, mild-to-moderate ulcerative colitis.

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Upsher-Smith launches phase III epilepsy study

Wednesday, July 20, 2011 11:08 AM

Upsher-Smith Laboratories initiated a phase III clinical trial to evaluate the safety and efficacy of USL261, an investigational intranasal midazolam, for the rescue treatment of seizures in patients on stable anti-epileptic drug (AED) regimens who require control of intermittent bouts of increased seizure activity, frequently referred to as seizure clusters. USL261 has been granted Orphan Drug designation for this use by the FDA.

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Inovio vaccine shows long-term durability

Wednesday, July 20, 2011 11:04 AM

Inovio Pharmaceuticals, a developer of therapeutic and preventive vaccines against cancers and infectious diseases, has reported long-term durability of T cell immune responses of up to over two years (at the latest time measured) in seven of eight evaluated patients following a fourth vaccination of VGX-3100, its investigational SynConR DNA vaccine for treating cervical dysplasia and cancer caused by human papillomavirus (HPV) that is delivered using intramuscular electroporation.

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Cleveland Clinic launches brain health study for pro fighters

Tuesday, July 19, 2011 01:55 PM

The Cleveland Clinic Lou Ruvo Center for Brain Health has launched a study with professional fighters that will help determine whether MRIs of the brain, along with other tests, can detect subtle changes in brain health that correlate with impaired thinking and functioning. The Center is working hand-in-hand with the Nevada Athletic Commission, Golden Boy Promotions, Top Rank Boxing and the UFC to spread the word about the importance of this research to the sport.

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BioMarin launches phase I BMN 673 trial

Tuesday, July 19, 2011 01:53 PM

BioMarin Pharmaceutical reported the initiation of a phase I trial for BMN 673, a poly ADP-ribose polymerase (PARP) inhibitor, for the treatment of patients with advanced hematological malignancies.  A phase I/II trial for BMN 673 for the treatment of patients with solid tumors was initiated in January 2011 and is ongoing.

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AiCuris presents results of AIC316 phase II

Tuesday, July 19, 2011 01:51 PM

Phase II results for AiCuris' novel non-nucleosidic herpes simplex virus (HSV) inhibitor AIC316 reveal safety and efficacy in persons with genital herpes.

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Advancell, Neurotec launch phase IIa multiple sclerosis trial

Tuesday, July 19, 2011 01:49 PM

Biotechnological companies Advancell and Neurotec Pharma, both based in Barcelona, Spain, have initiated a clinical phase IIa study with NT-KO-003, an innovative oral therapy for multiple sclerosis (MS). NT-KO-003 was co-developed by the two companies and its mechanism of action is completely different from the drugs currently used to treat MS.

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LEO Pharma and Scripps Research Institute collaborate

Tuesday, July 19, 2011 01:39 PM

LEO Pharma and The Scripps Research Institute have entered a research collaboration.

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ACT begins trials for macular dystrophy treatment

Friday, July 15, 2011 10:30 AM

Advanced Cell Technology announced the dosing of the first patients in each of its two phase I/II clinical trials for Stargardt's macular dystrophy and dry age-related macular degeneration (dry AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The patients were treated by Steven Schwartz, M.D., at the David Geffen School of Medicine at UCLA. Robert Lanza, M.D., chief scientific officer of ACT, attended the procedures. Both patients successfully underwent the outpatient transplantation surgeries and are recovering uneventfully.

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Inovio releases phase I flu vaccine results

Friday, July 15, 2011 10:27 AM

Inovio Pharmaceuticals, a developer of therapeutic and preventive vaccines against cancers and infectious diseases, announced that significant T cell and antibody responses were generated in its phase I clinical study of VGX-3400X, a SynCon DNA vaccine for the prevention of avian H5N1 influenza delivered using intramuscular (IM) electroporation.

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