Aestus Therapeutics Inc., of East Windsor, N.J., reported positive results from a Phase II trial evaluating the efficacy of its neuropathic pain therapeutic, ATx08-001 , in the treatment of post-herpetic neuralgia. Results showed that ATx08-001 monotherapy met the primary objective of demonstrating significant analgesia and showed an excellent safety profile. Originally developed to treat Type II diabetes, the selective PPAR modulator has been examined in Phase I and II studies comprising more than 800 patients. (See BioWorld Today, June 29, 2010.)
Anacor Pharmaceuticals Inc., of Palo Alto, Calif., reported preliminary Phase IIa data showing AN2728 and AN2898 each achieved their primary endpoint in mild-to-moderate atopic dermatitis. After 28 days, 64 percent of AN2728-treated lesions vs. 24 percent of placebo-treated lesions improved according to the Atopic Dermatitis Severity Index (ADSI) (p = 0.05), as did 71 percent of AN2898-treated lesions compared to 14 percent for control (p = 0.01). AN2728 and AN2898 are boron-based phosphodiesterase-4 inhibitors.
Catalyst Pharmaceutical Partners Inc., of Coral Gables, Fla., commenced its first Phase Ia safety study for its investigational drug, CPP-115, a GABA aminotransferase inhibitor being developed under a licensing agreement with Northwestern University. The randomized, double-blind, single-ascending dose study will evaluate the vigabatrin analogue in six cohorts of eight healthy volunteers. Catalyst expects to report the study results by the beginning of the second quarter of 2012. The biotech plans to develop CP-115 for several indications, including epilepsy, drug addiction and other central nervous system diseases.
Cubist Pharmaceuticals Inc., of Lexington, Mass., initiated a pivotal Phase III trial of CXA-201 (ceftolozane/tazobactam) in patients with complicated intra-abdominal infections. Cubist expects to enroll about 780 patients in the trial, which is the first of two global, double-blind, randomized Phase III studies that will compare the safety and efficacy of CXA-201 , in combination with metronidazole, to meropenem. The primary objective is to establish noninferiority with respect to the proportion of patients who achieve clinical cure 26 to 30 days after treatment begins. CXA-201 is being developed as a first-line intravenous therapy for the treatment of serious Gram-negative bacterial infections in the hospital, including those caused by Pseudomonas aeruginosa. CXA-201 also is in two Phase III trials to treat patients with complicated urinary tract infections.
Genentech Inc., a South San Francisco-based member of the Roche Group, initiated a first-in-human study with anti-IL-17, a fully human monoclonal antibody designed to bind to the human IL-17 family of cytokines. The antibody was licensed from NovImmune SA, of Plan-Les-Ouates, Switzerland. The initiation of the Phase I trial triggers an undisclosed milestone payment to NovImmune. (See BioWorld Today, July 27, 2010.)
GeoVax Labs Inc., of Atlanta, dosed the first patient in a Phase I/II trial of its HIV therapeutic vaccine.
Nektar Therapeutics Inc., of San Francisco, said oral mu-opioid agonist NKTR-181 was well-tolerated in a Phase I trial and exhibited a sustained analgesic response. Phase II trials are slated to begin next year.
Repros Therapeutics Inc., of The Woodlands, Texas, reported top-line Phase II data showing Androxal significantly increased testosterone levels at both the low and high doses vs. placebo (p < 0.0001) for hypogonadal men with Type II diabetes. There was a trend toward improved glycemic control in the men on the higher dose. Androxal was well tolerated with no man's testosterone going above the normal range.
Vaximm AG, of Basel, Switzerland, and Mannheim, Germany, initiated a Phase I trial of oral cancer vaccine VXM01 for pancreatic cancer. Initial data are expected in the first-half of 2013. VXM01 uses modified live attenuated bacteria as a carrier for VEGFR2 antigens. Vaximm is a spin-off of Merck KGaA, of Darmstadt, Germany.