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CLVS Zooms To New High, FLML Gets Thumbs Up, SNTA Dives, STEM Grows


AbbVie Inc. (ABBV) on Monday announced that its investigational oncology compound ABT-199, developed in partnership with Genentech, has demonstrated potential in treating patients with relapsed/refractory chronic lymphocytic leukemia, or CLL, in a phase I study.

The company's amended clinical trial protocols for studies of ABT-199 in patients with CLL were recently accepted by the FDA and enrollment for ABT-199 clinical trials in CLL, NHL and multiple myeloma has been re-instated. AbbVie and Genentech expect to move ABT-199 into later-stage clinical trials in the near future.

ABBV closed Monday's trading 1.57% higher at $43.36.

Biologix Hair Inc. (BLGX) rose over 9% on Monday after the company announced that its network has expanded from 196 clinics at the time of inception to 276 clinics through the end of April 2013. During the same period, the number of countries in which clinicians has been contracted has increased from 11 to 37.

BioTime Inc. (BTX) has offered to sell up to an aggregate of 2,180,016 common shares and 545,004 warrants to purchase common shares, in "units" with each unit consisting of one common share and one-quarter of a warrant, at an offering price of $4.155 per unit. The company expects to raise $9 million in the registered direct offering.

BTX closed Monday's trading at $4.82,up 1.47%. In extended trading, the stock fell 1.66% to $4.74.

Shares of Clovis Oncology Inc. (CLVS) surged as much as 136% on Monday after the company reported encouraging results from an ongoing phase I/II monotherapy study of its investigational drug Rucaparib in patients with ovarian cancer.

According to the trial results, Rucaparib demonstrated 89% clinical benefit rate in ovarian cancer patients across all doses. The company noted that the phase II dose has not yet defined and that the maximum tolerated dose has not been reached.

CytRx Corp. (CYTR) announced Monday that its drug candidate, Aldoxorubicin, administered at 90% of its single agent dose can be safely delivered in combination with Doxorubicin administered at 50% of its single agent dose to patients with advanced solid tumors. Aldoxorubicin is an improved version of the widely used chemotherapeutic agent Doxorubicin.

Doxorubicin, either alone or in combination with Ifosfamide, is considered the mainstay chemotherapeutic agent for the treatment of advanced, unresectable tumors. However, Doxorubicin has significant side effects, including chronic cardiotoxicity, which limits the dosage to a level below its maximum anti-tumor capabilities.

CYTR closed Monday's trading at $2.38, down 0.83%. In after-hours, the stock shed 1.26% to $2.35.

Flamel Technologies (FLML) set a new 52-week high of $5.83 following FDA approval of Bloxiverz, a drug used intravenously in the operating room for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery.

The company expects to launch Bloxiverz in July 2013 in 0.5 and 1.0 mg/mL strengths.

Hospira Inc.'s (HSP) post-marketing study of European biosimilar epoetin, Retacrit, has affirmed treatment response and tolerability in management of anemia secondary to chemotherapy of the drug. Retacrit was launched in Europe in early 2008.

HSP closed Monday's trading 1.76% higher at $35.29.

Isis Pharmaceuticals Inc.'s (ISIS) phase I study of ISIS-STAT3Rx in patients with metastatic cancer showed that the compound is capable of eliciting partial responses that were durable and prolonged in two out of three patients with diffuse large B-cell lymphoma who were refractory to prior chemotherapy treatments.

Isis and AstraZeneca are currently evaluating ISIS-STAT3Rx, in two clinical studies in patients with advanced lymphoma and metastatic liver cancer. The results from these trials are scheduled to be reported next year.

ISIS closed Monday's trading at $21.38, down 1.43%. In after-hours, the stock was up 1.13% at $21.62.

NewLink Genetics Corp. (NLNK) said that in a phase II study of its investigational drug, Algenpantucel-L, plus standard-of-care adjuvant therapy in patients with resected pancreatic cancer, the one year disease-free survival was 62 percent, while overall survival was 86 percent.

A phase III study with Algenpantucel-L for patients with surgically resected pancreatic cancer, dubbed the IMPRESS study, is currently underway.

NLNK rose 4.97% on Monday to close at $17.12.

With Health Canada authorizing StemCells Inc. (STEM) to expand its phase I/II clinical trial for chronic spinal cord injury, the company will be opening one or more trial sites in Canada and begin screening patients.

STEM closed Monday's trading 1.14% higher at $1.78. In after-hours, the stock gained another 3.37% to $1.84.

Shares of Synta Pharmaceuticals Corp. (SNTA) fell 34% on Monday despite reporting positive overall survival results from a phase 2b/3 trial of its investigational drug Ganetespib in second-line non-small cell lung cancer. In the study, dubbed GALAXY-1, there was improvement in overall survival and progression-free-survival when patients were treated with a combination of Ganetespib plus Docetaxel compared to Docetaxel alone.

TG Therapeutics Inc. (TGTX) announced that in a phase I/II clinical trial of its investigational monoclonal antibody, TG-1101, the compound was well tolerated and it induced 50% overall response rate. According to the trial results, 40% of Rituximab-refractory patients achieved a complete response and 100% of marginal zone lymphoma patients achieved a complete or partial response.

TGTX closed Monday's trading 2.34% down at $6.25.

by RTTNews Staff Writer

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