Plus   Neg

CLSN Craters, BTX, CYTR, CTIC Progress Clinically, Echo Fades, DYAX Does A Deal


BioTime Inc. (BTX) said Thursday that its subsidiary OncoCyte Corp. has made substantial progress in the development of a novel pan-cancer diagnostic product PanC-Dx. A multi-center clinical study of a blood-based diagnostic test for the early detection of cancer is planned for this year.

BTX closed Thursday's trading 1.77% higher at $4.60.

BSD Medical Corp. (BSDM) said Thursday that the latest sale of its BSD-500 Hyperthermia System is to a major East Coast academic medical center, which is launching an extensive new hyperthermia program. The BSD-500 is approved for the use of hyperthermia in conjunction with radiation therapy to treat certain tumors.

BSDM closed Thursday's trading at $1.55, up 2.65%.

CEL-SCI Corp. (CVM) announced that its longstanding collaboration with Northeast Ohio Medical University has produced a new investigational breast cancer vaccine which prevents and treats a HER-2/neu expressing breast cancer tumor in a mouse model of the disease.

CVM closed Thursday's trading at $0.28, up 1.52%.

CytRx Corp. (CYTR) has received recommendation from Data Safety Monitoring Committee to complete its global phase 2b clinical trial with Tamibarotene in combination with chemotherapeutical agents as a first-line treatment for patients with advanced non-small-cell lung cancer. At least 140 evaluable patients are expected to be enrolled in the trial in the first quarter of 2013.

Celsion Corp. (CLSN) plunged more than 80% on Thursday to $1.51 after the company announced that ThermoDox in combination with radiofrequency ablation did not meet the primary endpoint of the phase III HEAT Study in patients with hepatocellular carcinoma, also known as primary liver cancer.

Following the first interim survival analysis, an independent Data Safety Monitoring Board has recommended the continuation of Cell Therapeutics Inc.'s (CTIC) phase 3 clinical trial of OPAXIO, dubbed GOG-0212, as a maintenance therapy in ovarian cancer. The next interim analysis of the trial is expected to occur in the second half of 2013.

Dyax Corp. (DYAX) has entered into a strategic partnership with Novellus Biopharma AG for the development and commercialization of KALBITOR in select regions in Latin America, including Argentina, Brazil, Chile, Colombia, Mexico and Venezuela.

KALBITOR, which was discovered and developed by Dyax, is marketed in United States for the treatment of acute attacks of HAE (hereditary angioedema) in patients 16 years of age and older.

Echo Therapeutics Inc. (ECTE) dropped more than 10% in extended trading on Thursday after the company priced the public offering of 13 million shares of its common stock at $0.75 each. The gross proceeds from this offering are expected to be approximately $10.0 million. The offering is scheduled to close on or about February 6, 2013.

Galectin Therapeutics (GALT) has submitted an Investigational New Drug application for GR-MD-02 in the proposed indication of non-alcoholic steatohepatitis, or NASH with advanced fibrosis, or fatty liver disease. If the IND is accepted by the FDA, the company plans on proceeding with a phase 1 clinical trial.

GALT closed Thursday's trading at $2.57, down 3.02%.

Genentech, a unit of Roche Group (RHHBY) said Thursday that in a phase III study, dubbed CLL11, there was an improvement in progression-free survival with its investigational medicine Obinutuzumab (GA101) plus Chlorambucil chemotherapy compared to Chlorambucil alone in people with previously untreated chronic lymphocytic leukemia. GA101's clinical development program is designed to assess whether or not it is superior to Rituxan in CLL and non-Hodgkin's lymphoma. The company noted that data from CLL11 will be submitted to FDA and European regulatory authorities for potential approval.

Pfizer Inc. (PFE) has prevailed in its patent dispute against generic company Actavis Inc. (previously known as Watson Laboratories Inc) related to Sirolimus, the active ingredient in RAPAMUNE, for the inhibition of organ transplant rejection. Pfizer filed the lawsuit in April 2010 after Actavis applied to the FDA to market a generic version of RAPAMUNE.

Now that the ruling has gone in favor of Pfizer, Actavis will not be able to market its generic version of RAPAMUNE in the U.S. before Pfizer's patent expires on January 7, 2014, pending a possible appeal by Actavis.

Spectrum Pharmaceuticals (SPPI) has reacquired development and commercialization rights for phase 3 compound Apaziquone, in the United States, Europe and other territories from Allergan Inc. In exchange, Allergan will receive a royalty on future revenue.

Last April, Spectrum Pharma announced that two double blind, randomized, placebo controlled, phase 3 clinical trials for Apaziquone did not meet their primary endpoint of a statistically significant difference in the rate of tumor recurrence at 2 years between the two arms. However, analysis of the pooled data from both studies showed a statistically significant treatment effect in favor of Apaziquone.

The company held discussions with the FDA last month and has been told that an NDA filing with the current Phase III data of Apaziquone can be accepted. Spectrum anticipates an Advisory Committee meeting to review a potential NDA for Apaziquone.

SPPI rose 5.70% to close Thursday's trading at $12.61.

Vanda Pharmaceuticals Inc. (VNDA) Thursday said that a phase IIb/III clinical study of Tasimelteon as a monotherapy in the treatment of patients with Major Depressive Disorder did not meet the primary endpoint. The company has decided to discontinue evaluation of Tasimelteon in the indication of Major Depressive Disorder.

Earlier, in 2 phase III trials, Tasimelteon has demonstrated its efficacy in the treatment of Non-24-Hour Disorder, and the company plans to submit a New Drug Application for Tasimelteon in the indication of Non-24-Hour Disorder in mid-2013.

Shareholders of YM BioSciences Inc. (YMI) (YM.TO) on Thursday approved the previously announced plan of arrangement with Nova Scotia Limited, a wholly-owned subsidiary of Gilead Sciences Inc. (GILD).

Under the Arrangement, Nova Scotia will acquire all of the issued and outstanding common shares of YM BioSciences for U.S. $2.95 per share in cash. In addition, holders of warrants and options will each receive a cash payment equal to the difference between U.S. $2.95 and the exercise price of such warrants or options.

by RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Follow RTT