FPRX Awaits Data In Q1, EC Gives Thumbs Up To AMGN's Kyprolis, Telesta Plunges

(RTTNews) - Aeterna Zentaris Inc.'s (AEZS)(AEZ.TO) confirmatory phase III clinical study of its investigational compound Macrilen for adult growth hormone deficiency has enrolled the first patient.

The trial is a two-way crossover study with the insulin tolerance test as the benchmark comparator and will enroll approximately 110 subjects with a medical history documenting risk factors for adult growth hormone deficiency.

The NDA for Macrilen was issued a complete response letter last November - with the FDA requesting the company to demonstrate the efficacy of Macrilen as a diagnostic test for growth hormone deficiency in a new, confirmatory clinical study.

AEZS closed Thursday's trading at $0.04, down 4.76%.

The European Commission has granted marketing authorization for Amgen's (AMGN) Kyprolis in combination with Revlimid (lenalidomide) and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. The FDA approved the same combination for the same indication in July of this year.

Kyprolis is also indicated under FDA accelerated approval as a single agent for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent.

Kyprolis is a product of Onyx Pharmaceuticals Inc. which was acquired by Amgen in 2013.

Total sales of Kyprolis were $331 million in 2014 - the first full year of commercialization since the acquisition of Onyx. Sales of the drug totaled $137 million in Q3-2015, up 46% over the year-ago quarter.

AMGN closed Thursday's trading at $159.49, down 0.89%.

Dermira Inc. (DERM) has completed enrollment in its second phase III trial of its drug candidate CIMZIA in patients with moderate-to-severe plaque psoriasis, dubbed CIMPASI-1.

The first phase III clinical trial, CIMPASI-2, completed enrollment in September 2015, and the third and final trial in the clinical development program, dubbed CIMPACT, continues to enroll patients.

Dermira expects to announce topline efficacy and safety data from the CIMZIA Phase 3 clinical development program in 2017.

DERM closed Thursday's trading at $28.10, down 1.20%.

Five Prime Therapeutics Inc. (FPRX) has completed the dose escalation part of the ongoing phase 1 trial of FPA144 in patients with solid tumors, including unselected gastric cancer patients. Data from the Part 1 will be presented at the American Society of Clinical Oncology's Gastrointestinal Cancers Symposium in January 2016.

FPRX closed Thursday's trading at $34.68, up 0.61%.

Shares of Telesta Therapeutics Inc. (TST.TO) plunged 44% on Thursday after an FDA panel voted against recommending the company's investigational product MCNA for high risk non-muscle invasive bladder cancer patients who are refractory to or relapsing from first line therapy with bacillus Calmette-Guérin (BCG).

The Advisory Committee voted 18 no to 6 yes, with no abstentions for the question "Does MCNA have an overall favorable benefit-risk profile for the treatment of non-muscle invasive bladder cancer at high risk of recurrence or progression in adult patients who failed prior BCG immunotherapy, e.g., in patients who are BCG-refractory or BCG-relapsing?"

The FDA's final decision is slated for February 27, 2016. The FDA usually follows the recommendations of its advisory panels, although it is not bound to do so.

TST.TO closed Thursday's trading at $0.17, down 44.07%.

Vital Therapies Inc. (VTL) expects the first patient in its phase 3 clinical trial, dubbed VTL-308, to be enrolled in the first half of 2016. The trial is designed to evaluate ELAD System in subjects with alcohol induced liver disease , and final results are anticipated in mid-2018.

VTL closed Thursday's trading at $7.86, up 4.52%.