Sequella, Inc. drug compound SQ109 selected for phase 1B clinical trial program



Just as the emotions it represents are dynamic, the heart’s development requires dynamic shifts in proteins that prompt alternative spicing, a mechanism that allows a given gene to program the cell to make several proteins, said a group of researchers at Baylor College of Medicine in a report that appears online in the journal Proceedings

Full Post: Alternative splicing proteins prompt heart development

Sequella, Inc., a clinical-stage biopharmaceutical company focused on diseases of epidemic potential, announced today that SQ109, its lead drug candidate for the treatment of tuberculosis (TB), was the first drug approved for evaluation in a newly awarded clinical program contract to Dynport Vaccine Company LLC and Quintiles Transnational.

The contract, awarded by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), is part of NIAID’s clinical resource infrastructure to accelerate Phase 1 studies of promising clinical stage drugs or vaccines that address emerging and re-emerging infectious tropical diseases and bioweapon pathogens. The Phase 1B clinical study of SQ109 should be initiated in Q1 2009.

SQ-109 is a new diamine antibiotic intended to replace one or more of the current first-line anti-TB drugs and simplify patient therapy. SQ109 was granted U.S. FDA Fast Track designation and FDA/EMEA Orphan Drug Designation in 2007. SQ109 shows activity against drug sensitive and multi-drug resistant (MDR and XDR) Mycobacterium tuberculosis, the causative agent of TB. The Phase 1B study will assess safety and pharmacokinetics of multiple doses of SQ109 in healthy subjects.

“This is absolutely the best of both worlds for Sequella,” commented Dr. Carol Nacy, Sequella CEO. “We again successfully competed for support from our most valued funding partner, NIAID, while retaining the capacity to work with the same industry-leading contract research organization, Quintiles Transnational, that conducted our first-in-human Phase 1A trial for SQ109.

The trial will be conducted at the Overland Park Quintiles Transnational Phase 1 facility in Lenexa, Kansas.

http://www.nih.gov/

Link




Bolder BioTechnology, Inc. today announced that it has been awarded a $1.9 million Phase II Small Business Innovation Research (SBIR) grant from the National Institute of Allergy and Infectious Diseases (NIAID) of The National Institutes of Health (NIH). The grant will be used to perform additional preclinical toxicology and pharmacology studies of the company’s proprietary

Full Post: Bolder BioTechnology awarded NIH grant to continue development of growth hormone product



Chimerix, Inc., a biotechnology company developing orally available antiviral therapeutics, has announced that the Company has completed a single and multi-dose Phase I study of CMX001 in healthy volunteers. This study supports the further development of the drug for multiple dsDNA infections. The Company has initiated the first Phase II multi-dose clinical trial in patients.

Full Post: Chimerix completes phase I study and starts phase II multi-dose trial for CMX001



Vical Incorporated has announced that the company’s Vaxfectin-formulated H5N1 pandemic influenza DNA vaccines induced T-cell responses against a matching strain of influenza virus and demonstrated cross-clade antibody responses against a different strain in a Phase 1 clinical trial. The company previously reported that the vaccines had achieved potentially protective levels of antibody responses in

Full Post: Vaxfectin-formulated H5N1 pandemic influenza achieves T-cell responses and cross-clade reactivity in humans



Reata Pharmaceuticals, Inc. has announced that RTA 402 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. RTA 402 is currently being studied in a Phase 1/2 trial in patients with pancreatic cancer, and is also in Phase 2 development for chronic kidney disease.

Full Post: FDA grants orphan drug status to Reata’s pancreatic cancer drug



Testing very young babies for HIV and giving antiretroviral therapy (ART) immediately to those found infected with the virus dramatically prevents illness and death, according to a report in the New England Journal of Medicine. The study found that giving ART to HIV-infected infants beginning at an average age of 7 weeks made them four

Full Post: Results out from first phase III randomized clinical trial to study the best time to begin ART in infants