ATHX Suffers Another Blow, MRK's Keytruda Proven Superior, TROV Outperforms

(RTTNews) - Athersys Inc. (ATHX) suffered a blow on Friday with the stock price dropping to a new 52-week low, on news that the primary and secondary endpoints of the company's phase II study of MultiStem cell therapy for treatment of ischemic stroke did not show a difference at 90 days compared to placebo.

MultiStem is a proprietary stem cell product that is manufactured from human stem cells obtained from adult bone marrow or other nonembryonic tissue sources.

In the phase II study, the stroke victims were administered MultiStem cells or placebo intravenously one to two days after the stroke had occurred.

The primary endpoints for the study include safety over the first seven days following treatment and global stroke recovery at day 90, which assesses global disability (modified Rankin Score), neurological deficit (NIH stroke scale) and activities of daily living (Barthel Index).

A phase II study of MultiStem for ulcerative colitis, conducted by Pfizer Inc. (PFE) under a collaboration and license agreement with Athersys, had also failed to show meaningful benefit, following a single administration, at eight weeks. The results of this study were announced last April.

ATHX plunged 35.78% on Friday to close at $1.40.

Merck & Co. Inc.'s (MRK) Keytruda (Pembrolizumab) has demonstrated superior survival, progression free survival and overall response rate compared to Bristol-Myers Squibb's (BMY) Yervoy (ipilimumab) in a phase III study of patients with advanced melanoma.

In the phase III study, dubbed KEYNOTE-006, 834 patients with unresectable stage III or IV advanced melanoma with no more than one prior systemic therapy were enrolled, and they were randomized to receive either Pembrolizumab 10 mg/kg every two weeks, Pembrolizumab 10 mg/kg every three weeks or four cycles of Yervoy 3 mg/kg every three weeks.

Based on the KEYNOTE-006 data, Merck plans to submit a supplemental Biologics License Application for Keytruda for the first-line treatment of advanced melanoma in mid-2015.

Keytruda secured accelerated FDA approval for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs last September.

Merck has also submitted a Biologics License Application to the FDA for Keytruda for the treatment of advanced non-small cell lung cancer.

MRK closed Friday's trading at $56.88, down 1.66%.

Oncolytics Biotech Inc.'s (ONCY) lead product candidate, REOLYSIN , has been granted Orphan Drug Designation by the FDA for the treatment of malignant glioma.

REOLYSIN is under phase I/II studies in patients with recurrent malignant gliomas. The compound is also being explored in various other indications like advanced malignancies, tumors, ovarian cancer and head and neck cancers.

ONCY closed Friday's trading at $0.76, up 10.27%.

RXi Pharmaceuticals Corp.'s (RXII) drug candidate Samcyprone has been granted Orphan Drug Designation by the FDA for the treatment of Malignant Melanoma Stage IIb to IV.

Samcyprone is a topical formulation of Diphenylcylcopropenone in clinical development for the treatment of warts, alopecia areata and cutaneous metastases of melanoma.

Currently, an investigator sponsored clinical trial of Samcyprone in cutaneous metastases of melanoma, as well as a new investigator sponsored clinical trial in alopecia areata are ongoing. In addition, RXi plans to initiate a phase 2a clinical trial in warts for Samcyprone by the end of this year.

RXII closed Friday's trading at $0.73, up 3.57%.

Shares of TrovaGene Inc. (TROV) surged more than 20% on Friday on news that the company's urine-based Precision Cancer Monitoring, or PCM, platform outperformed tissue biopsy for the detection and monitoring of EGFR T790M mutations in metastatic lung cancer patients.

In an interim analysis of 34 patients from an ongoing clinical study, Trovagene's PCM platform detected the T790M mutation in all patients who were positive for the mutation in tissue biopsy. The company's urine-based assay identified additional patients as T790M-positive, including those who had clinical suspicion of T790M-progressive disease, but were either negative by tissue biopsy or had not yet undergone tissue biopsy for confirmation.

The PCM platform detected EGFR T790M resistance mutations months earlier than radiologic detection of progression in patients, noted the company.

TROV was one of our stock picks in the month of February, and it was trading around $5.00 then. The stock touched a new high of $9.18 on Friday before closing the day's trading 20.14% higher at $8.53.