HRTX Abuzz, ILMN Disappoints, STEM Grows, LLY Abandons TTHI's Diabetes Drug

pharma 041916

ARCA biopharma Inc.'s (ABIO) phase IIb/III clinical trial evaluating Gencaro as a potential treatment for atrial fibrillation has enrolled the 75th patient. This number represents the midpoint of the minimum number of patients to be evaluated in the phase IIb portion of the trial.

The trial, dubbed GENETIC-AF, is expected to enroll at least 150 patients by the end of 2016. The company expects the outcome of a pre-specified GENETIC-AF Data Safety Monitoring Board interim efficacy, safety and futility analysis of data from approximately 150 patients in the second quarter of 2017.

Based on the outcome of the interim analysis, the DSMB will recommend whether or not the GENETIC-AF trial should proceed to the phase III portion of the trial, noted the company.

ABIO closed Monday's trading at $3.66, down 2.14%.

Celldex Therapeutics Inc.'s (CLDX) investigational combination of Varlilumab, and Bristol-Myers Squibb's (BMY) approved immunotherapy Opdivo showed acceptable tolerability and safety across all dose levels without any evidence of increased autoimmunity or inappropriate immune activation, according to data from a phase I portion of a phase 1/2 dose escalation and cohort expansion study.

The combination regimen also produced favorable changes in intratumoral immune biomarkers, most notably an increase in tumor infiltrating lymphocytes, which is recognized to correlate with improved clinical outcome, according to the company.

CLDX closed Monday's trading at $4.40, down 5.17%.

Chiasma Inc. (CHMA) plunged over 60% on Monday after being asked to conduct another clinical trial in order for its investigational drug Mycapssa, proposed for maintenance treatment of adult patients with acromegaly, to be approved.

In its complete response letter issued late Friday, the FDA noted that it not believe the company's NDA for Mycapssa had provided substantial evidence of efficacy.

Chiasma had cash of approximately $134 million at March 31, 2016.

CHMA closed Monday's trading at $3.75, down 63.13%.

Discovery Laboratories Inc.'s (DSCO) name is changed to Windtree Therapeutics Inc. and will trade under the Nasdaq symbol "WINT" effective at market open on Tuesday, April 19, 2016.

The company's lead product candidate is AEROSURF that is being developed to potentially reduce or eliminate the need for endotracheal intubation and mechanical ventilation in the treatment of premature infants with respiratory distress syndrome (RDS).

DSCO closed Monday's trading at $3.50, down 9.33%.

Dynavax Technologies Corp.'s (DVAX) lead immunotherapy product candidate, SD-101, in combination with low-dose radiation in lymphoma patients induces systemic anti-tumor response and is well tolerated across all dose cohorts with no dose limiting toxicities, according to data from Part 1 of a phase I/II study.

The phase II expansion portion of the study is ongoing and is currently enrolling two dose cohorts. The primary endpoints of the trial are maximum tolerated dose (MTD) and evaluation of the safety of intratumoral SD-101 in combination with low dose radiotherapy, noted the company.

Separately, the company announced positive results of a pivotal phase III trial that compared the safety and immunogenicity data of its investigational adult hepatitis B vaccine, HEPLISAV-B, with the leading vaccine, Engerix-B, in adults 18 to 70 years of age.

HEPLISAV-B provided a statistically significant higher rate of protection with fewer doses than Engerix-B with a similar safety profile. HEPLISAV-B is under FDA review, with a decision date set for September 15, 2016.

DVAX closed Monday's trading 4.91% higher at $22.20.

Heron Therapeutics Inc. (HRTX), which has been awaiting FDA word on its investigational drug SUSTOL, has been informed by the regulatory agency that there are no substantive deficiencies in the resubmitted NDA for SUSTOL. The company said that discussions with FDA regarding labeling are underway.

Heron is seeking approval of SUSTOL for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) regimens.
SUSTOL was issued a complete response letter twice, in 2013 and 2010, requesting additional data.

Addressing the concerns raised by the FDA in the complete response letter of 2013, Heron resubmitted the New Drug Application for SUSTOL last July and a decision was to be announced in early April.

HRTX closed Monday's trading at $21.49, up 2.77%. In after-hours, the stock was up 16.33% to $25.

Shares of Illumina Inc. (ILMN) were down over 18% in extended trading on Monday after the company announced its preliminary revenue for first quarter of fiscal year 2016, which were short of expectations.

The company expects revenue of approximately $572 million in the first quarter of fiscal 2016 - a 6% increase compared to $539 million in the first quarter of 2015 and 7% growth on a constant currency basis. Analysts polled by Thomson Reuters were expecting the company to report revenue of $596.33 million.

The results for first fiscal quarter 2016 are slated for release following the close of market on Tuesday, May 3, 2016.

ILMN closed Monday's trading at $178.13, up 2.59%. In after-hours, the stock fell 18.49% to $145.20.

Ohr Pharmaceutical Inc.'s (OHRP) first phase III clinical trial of its lead drug candidate Squalamine for the treatment of neovascular age-related macular degeneration has enrolled the first patient.

The first of two trials will include approximately 165 centers in the United States and Canada with a target enrollment of 650 treatment naïve subjects with wet AMD., said the company.

OHRP closed Monday's trading at $3.55.

Otonomy Inc. (OTIC) intends to initiate a single phase III trial for OTIPRIO in patients with acute otitis externa, also known as swimmer's ear, during the second quarter of 2016.

OTIPRIO was approved by the FDA last December for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement.

If all goes well as planned, the company expects to complete the phase III trial and report topline results in the fourth quarter of 2016. If the results are positive then Otonomy expects to submit a supplemental New Drug Application to the FDA in the first half of 2017.

OTIC closed Monday's trading at $17.50, up 1.04%.

Shares of StemCells Inc. (STEM) rose over 13% on Monday, following encouraging 6-month results from its phase II study of HuCNS-SC cells for the treatment of chronic cervical spinal cord injuries.

The results included a top line update for the six patients enrolled in open label Cohort I of the study. According to the company, results from Cohort I showed that muscle strength had improved in five of the six patients with four of these five patients also demonstrating improved performance on functional tasks assessing dexterity and fine motor skills.

In addition, four of the six patients had improvement in the level of cord injury as measured by ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury) assessment. The company expects to release detailed final 12-month results on this first open-label cohort later this quarter.

STEM closed Monday's trading at $0.26, up 13.61%.

Shares of Transition Therapeutics Inc. (TTHI) (TTH.TO) were down more than 37% on Monday after being notified that Eli Lilly and Co. (LLY) will not elect to advance diabetes drug candidate, TT401 into phase III development.

In March 2010, Transition licensed a series of pre-clinical compounds from Lilly, including TT401. In June 2013, Lilly exercised its option to assume all development and commercialization rights of TT401.

In a recently completed phase II study, the results of which were announced in February, TT401 demonstrated HbA1c improvements of up to -1.43% (similar to the exenatide arm). All TT401 dose arms and the exenatide arm were statistically significant relative to the placebo arm at Weeks 12 and 24.

Now that Lilly has abandoned the development of TT401, all the development and commercialization rights related to the drug candidate will be transferred to Transition.

TTHI closed Monday's trading at $0.78, down 37.59%.

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