PETX On The Move, IMGN To Pocket $5Mln, RGLS Gets Richer, MYGN Does It Again

(RTTNews) - Advaxis Inc. (ADXS) said that a phase 1/2 trial of its experimental drug ADXS-HPV in 25 patients with Human Papilloma Virus (HPV)-positive head and neck cancer will be initiated by the Icahn School of Medicine at Mount Sinai.

The company noted that this clinical trial will be the first study to evaluate the effects of ADXS-HPV in patients when they are initially diagnosed with HPV-associated head and neck cancer, prior to receiving any chemotherapy or radiation.

ADXS closed Wednesday's trading 1.18% higher at $3.42.

Amicus Therapeutics (FOLD) and GlaxoSmithKline plc (GSK) have once again amended the revised 2012 agreement that was signed related to Migalastat HCl, an investigational treatment for Fabry disease.

Migalastat HCl is currently under phase III development.

The new agreement gives Amicus global rights to develop and commercialize Migalastat HCl as a monotherapy and in combination with enzyme replacement therapy for Fabry disease. Under the prior agreement entered into in July 2012, Amicus and GSK were co-developing Migalastat HCl globally and GSK had rights to commercialize Migalastat HCl outside the U.S.

GlaxoSmithKline will further invest $3 million in Amicus through an equity investment in a concurrent private placement in public equity transaction, and will be eligible for future regulatory and commercial milestone payments, as well as royalty payments.

FOLD closed Wednesday's trading at $2.12, down 2.30%. In after-hours, the stock lost another 2.36% to $2.07.

Aratana Therapeutics Inc.'s (PETX) AT-001, an experimental drug for treating pain in dogs with osteoarthritis has demonstrated improvements in pain assessment scores that were statistically significant compared to placebo at a once-daily dose.

AT-001 will move into the pivotal field effectiveness study in 2014, and if things pan out the way as planned, it will be commercialized, upon approval, which is anticipated to be in 2016.

PETX closed Wednesday's trading 1.88% higher at $18.97.

CytRx Corp. (CYTR) has initiated a phase II clinical trial of its drug candidate Aldoxorubicin for the treatment of unresectable glioblastoma multiforme (GBM), a deadly form of brain cancer.

The clinical trial, which is expected to enroll up to 28 subjects, will have progression-free survival and overall survival as primary objectives and safety as the principal secondary objective.

The company expects to have preliminary results from this phase II trial in 2014.

CYTR closed Wednesday's trading at $2.15, down 4.87.

ImmunoGen Inc. (IMGN) is all set to receive a $5 million milestone payment from Swiss drug maker Roche AG, following the approval of breast cancer drug Kadcyla in the European Union.

Kadcyla comprises of Roche's trastuzumab antibody and ImmunoGen's ADC technology. The drug was approved by FDA in February of this year.

IMGN closed Wednesday's trading 0.07% higher at $14.04.

Myriad Genetics Inc. (MYGN) has signed a second research collaboration for its Homologous Recombination Deficiency test with BioMarin. The terms of the deal were not disclosed.

The new collaboration allows BioMarin to use the novel HRD (Homologous Recombination Deficiency) test to identify tumor types that may be sensitive to its investigational product candidate, BMN-673.

In October, BioMarin announced the use Myriad's BRACAnalysis test in connection with its pivotal phase III clinical study of BMN-673 for breast cancer.

MYGN closed Wednesday's trading 2.75% higher at $28.35.

Regulus Therapeutics Inc. (RGLS), which has research collaboration with Biogen Idec (BIIB) to explore microRNAs as biomarkers for multiple sclerosis, said that it has demonstrated initial progress in the collaboration. The company also noted that it has received a milestone payment.

RGLS closed Wednesday's trading at $6.26, up 4.33%.