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CTIC Persists, TPIV Clears Hurdles, THRX Files MAA, INO Readying Shot


Cell Therapeutics Inc. (CTIC) has begun enrolling patients in a phase III clinical trial, known as PERSIST-1, evaluating its investigational drug Pacritinib for the treatment of patients with myelofibrosis. The trial is expected to enroll 270 patients.

CTIC closed Wednesday's trading at $1.40, down 13.8%.

Synageva BioPharma Corp. (GEVA) on Wednesday announced it has closed the public offering and exercise of option to purchase additional shares at $47.53 per share. The company's compound under clinical development is Sebelipase alfa (SBC-102), an enzyme replacement therapy for Lysosomal Acid Lipase deficiency, a lysosomal storage disorder.

GEVA has traded in a 52-week range of $30.30 to $58.00. The stock closed Wednesday's trading 1.57% higher at $49.16.

TapImmune Inc. (TPIV.OB) said Wednesday that an interim safety analysis on the first five breast cancer patients treated with HER2/neu Class II antigens at Mayo Clinic, Rochester, MN, did not show any serious adverse events. Since there were no safety issues, the remaining 17 patients in the phase I study will also be treated.

The proprietary HER2/neu Class II antigens were discovered by Keith Knutson and colleagues at Mayo Clinic.

The phase I study is sponsored by TapImmune and it has an exclusive option to license the antigen technology at the end of the phase I study.

Ligand Pharmaceuticals Inc. (LGND) on Wednesday received an equity milestone payment from its partner Retrophin Inc. (RTRX) for the development and commercialization of Retrophin's lead clinical candidate RE-021, formerly known as DARA (a Dual Acting Receptor Antagonist of Angiotensin and Endothelin receptors).

RE-021 is in development for the treatment of focal segmental glomerulosclerosis, a rare disease that attacks the kidney's filtering system, causing serious scarring, progressive kidney function degeneration and rapid loss of the kidneys.

The shares issued to Ligand represent about 7% of Retrophin's outstanding capital stock and may be subject to certain trading restrictions.

Orthofix International N.V., (OFIX) on Wednesday announced that it has launched its implant - CONSTRUX Mini PEEK Titanium Composite Spacer System, through its spine distribution network.

The company noted that the launch of CONSTRUX Mini PEEK Titanium Composite Spacer System represents the beginning of a series of product launches in 2013 that will bring its cervical implant product offering to the forefront of the industry.

Theravance Inc. (THRX) on Wednesday announced the submission of a regulatory application in the European Union for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease, or COPD, with the proposed proprietary name ANORO.

A regulatory application for UMEC/VI, for patients with COPD was submitted to the FDA on December 18, 2012. UMEC/VI is a development program under Theravance's respiratory franchise that is partnered with GlaxoSmithKline plc (GSK).

Inovio Pharmaceuticals Inc. (INO) is all set to move its hepatitis C therapeutic vaccine - INO-8000, into a phase I/IIa clinical trial by the end of 2013, following outstanding results in a preclinical study.

INO-8000 is designed to broadly cover HCV genotypes 1a and 1b, the types that have been most difficult to treat with drug therapies. Inovio has an agreement in place with VGX International for the development of INO-8000.

INO closed Wednesday's trading at $0.62, up 1.37%.

by RTTNews Staff Writer

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