AGIO's Stellar Run, ONVO's Much Awaited Day, CYTR Slides For A Reason

(RTTNews) - Agios Pharmaceuticals Inc. (AGIO) on Tuesday reported early favorable safety profile and clinical activity of AG-120 in a phase I trial evaluating the drug candidate as a single agent in advanced acute Myeloid Leukemia.

As of October 17, 2014, the ongoing phase I trial for AG-120 had enrolled 17 patients with a documented IDH1 mutation whose cancer relapsed or failed to respond (refractory) to at least one prior treatment regimen, according to the company. The primary objectives of the phase I trial are to determine the maximum tolerated dose (MTD) and the recommended dose for further study of AG-120.

The other compounds in the pipeline are AG-221, under phase I trial in advanced hematologic malignancies and phase I/II clinical trial in advanced solid tumors, and AG-348, under phase I multiple ascending dose escalation trial in healthy volunteers. The company expects to initiate a phase II clinical trial for AG-348 in early 2015 in patients with pyruvate kinase deficiency.

AGIO has had an impressive run over the past year, climbing from $17 to $83. The stock closed Tuesday's trading at $83.81, down 1.26%.

Bio-Rad Laboratories Inc.'s (BIO) Geenius HIV 1/2 Supplemental Assay has received Premarket Application approval from the FDA.

The Geenius HIV 1/2 Supplemental Assay is a single-use immunochromatographic assay intended for use as an additional, more specific, test to confirm the presence of and differentiate antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1 and HIV-2) for specimens found to be repeatedly reactive by diagnostic screening procedures. The assay may also be used to confirm the presence of antibodies to HIV-1 and/or HIV-2 in pediatric subjects (children as young as 2 years old), the company said.

BIO closed Tuesday's trading 1.26% higher at $114.70.

Can-Fite BioPharma Ltd. (CANF) has a couple of events to watch out for in the coming months.

The company will be announcing data from a phase II/III trial of CF101 in 300 psoriasis patients for which positive interim data from the first 100 patients have already been received. The phase II study data of CF101 in glaucoma patients are scheduled to be announced in Q2/Q3 2015.

Can-Fite is also planning phase III trials of CF101 for rheumatoid arthritis this quarter.

CANF closed Tuesday's trading 23.51% higher at $3.

Cynosure Inc. (CYNO) has signed an exclusive agreement with El.En. S.p.A., a leader in the production of laser systems, to market and distribute in North America its MonaLisa Touch.

MonaLisa Touch is a carbon dioxide laser for the treatment of vaginal atrophy, a condition that affects primarily postmenopausal women, breast cancer survivors and women who have undergone hysterectomies.

Cynosure expects to begin selling MonaLisa Touch in the U.S. in the first quarter of 2015 through a specialty surgical sales force.

CYNO closed Tuesday's trading at $26.90, down 3.41%.

CytRx Corp. (CYTR) slipped more than 8 percent on Tuesday, following FDA's partial hold on the company's clinical trials for Aldoxorubicin.

The partial clinical hold is due to the reported death of a patient with advanced-stage cancer who did not qualify to participate in any of the ongoing Aldoxorubicin clinical trials, but had received Aldoxorubicin under the company's expanded access ("compassionate use") program.

Aldoxorubicin is currently under the following clinical trials:

- a pivotal phase III trial as a therapy for patients with soft tissue sarcoma whose tumors have progressed following treatment with chemotherapy; a global Phase 2b clinical trial in small cell lung cancer; a Phase 2 clinical trial in HIV-related Kaposi's sarcoma; a Phase 2 clinical trial in patients with late-stage glioblastoma (brain cancer); a Phase 1b trial in combination with ifosfamide in patients with soft tissue sarcoma, and a Phase 1b trial in combination with gemcitabine in subjects with metastatic solid tumors.

The company noted that while no new patients will be enrolled in the clinical trials until the clinical hold is lifted, all currently enrolled patients can continue receiving Aldoxorubicin treatment, or comparator drugs, as per study protocols.

CYTR closed Tuesday's trading at $2.52, down 8.70%.

Galena Biopharma Inc. (GALE) has completed enrollment in a phase II clinical trial of its product candidate GALE-401, six months ahead of schedule.

GALE-401 is a controlled release formulation of Anagrelide. Anagrelide is approved in the U.S. and Europe for treating high platelets counts in patients with bone marrow disorders.

The phase II, clinical proof-of-concept study of GALE-401 is treating 18 patients with elevated platelet counts in myeloproliferative neoplasms (MPNs) including Essential Thrombocythemia (ET), Polycythemia Vera (PV), and Primary Myelofibrosis (PMF). The company expects to present key data from the trial in 2015.

GALE closed Tuesday's trading at $1.84, up 1.66%.

NxStage Medical Inc. (NXTM) has launched its new Streamline Express dialyzer for the in-center, hemodialysis market. The dialyzer, designed to reduce the amount of labor required for machine set-ups, enables achievement of high clearances due to even dialysate distribution and low protein adsorption which limits performance drop in the course of treatment.

NXTM has rallied more than 30% over the past 1 month. The stock closed Tuesday's trading 2.06% higher at $17.85.

The day that investors of Organovo Holdings Inc. (ONVO) have been waiting for has finally arrived!! The company on Tuesday announced the full commercial release of its exVive3D Human Liver Tissue for preclinical drug discovery testing.

The exVive3D model is intended to provide human-specific data to aid in the prediction of liver tissue toxicity or ADME (Absorption, Distribution, Metabolism, Excretion) outcomes in later stage preclinical drug discovery programs.

Organovo's exVive3D Liver Models are bioprinted, living 3D human liver tissues consisting of primary human hepatocytes, stellate, and endothelial cell types, which are found in native human liver.

ONVO closed Tuesday's trading 9.77% higher at $6.74.