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ARIA's Agenda, New Faces At CBLI, PCYC Scores Hat-trick, NVIV To Uplist

ARIAD Pharmaceuticals Inc. (ARIA) Monday announced that its approved leukemia drug Iclusig has shown to potently inhibit RET, a clinically proven oncogenic driver of medullary thyroid cancer and non-small cell lung cancer, and FGFR, which is commonly mutated in endometrial, lung and other cancers in preclinical studies.

The company expects to start a phase II investigator-sponsored trial of Iclusig in patients with RET-positive NSCLC in this second quarter of 2013.
Iclusig received FDA approval to treat chronic myelogenous leukemia and acute lymphoblastic leukemia in December of 2012.

ARIA closed Monday's trading 2.19% higher at $17.25.

Arno Therapeutics Inc. (ARNI) announced that its investigational progestin receptor antagonist Onapristone has demonstrated anti-tumor activity in preclinical and clinical studies of hormone-dependent tumors. The company plans to initiate phase I clinical studies in Onapristone in the second half of 2013.

Cleveland BioLabs Inc. (CBLI) rose more than 3% to $2.04 following the appointment of key clinical development and regulatory affairs executives, a move which is meant to optimally position the company for successful development of its drug candidates.

The new team members include, Jean Viallet, who has been appointed as Chief Development Officer, Gillian Miller, who has taken over as Regulatory Affairs and Judith Schnyder, who has been names the Director of Clinical Operations.

Immunomedics Inc. (IMMU) has created a new class of antibody-cytokine conjugates using its patented DOCK-AND-LOCK DNL platform technology. The DNL complexes demonstrated potent anti-tumor activity in preclinical studies, said the company.

IMMU closed Monday's trading at $2.46, down 5.02%.

Immunovative Inc. (IMUN.OB) has changed its name to Tauriga Sciences Inc. and trading symbol to TAUG.OB, and the changes will be effective at market open on Tuesday, April 09, 2013.

IMUN.OB closed Monday's trading 0.56% higher at $0.09.

Shares of InVivo Therapeutics Holdings Corp. (NVIV), which trade on over the counter Bulletin Board, touched a new 52-week high of $3.21 in intraday trading on Monday after the company announced its plans to uplist its stock to a national securities exchange such as NASDAQ or NYSE MKT.

Accordingly, the company has commenced an offer to exchange outstanding warrants issued in 2010 to purchase approximately 15.0 million common shares for new warrants. The 2010 warrants have exercise prices of $1.40 and $1.00 per share and expire in 2015. The exchange offer will expire at 11:59 p.m. on May 6, 2013 unless extended.

Merrimack Pharmaceuticals Inc. (MACK) on Monday announced that its investigational compound MM-121 in combination with approved breast cancer drug letrozole has shown to restore tumor sensitivity and delay the onset of resistance to letrozole in estrogen-receptor-positive, or ER+, breast cancer in preclinical studies.

MACK closed Monday's trading at $6.05, down 1.63%.

Pharmacyclics Inc. (PCYC) has received the third Breakthrough Therapy Designation for its phase III cancer compound Ibrutinib from the FDA. This time it is for Ibrutinib as monotherapy for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma patients with deletion of the short arm of chromosome 17.

In February 2013, FDA granted Breakthrough Therapy Designations for Ibrutinib as a monotherapy for the treatment of patients with relapsed or refractory mantle cell lymphoma and as a monotherapy for the treatment of patients with Waldenstrom's macroglobulinemia.

Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions.

Ibrutinib is currently in development by Pharmacyclics and Janssen for several B-cell malignancies, including chronic leukemia and lymphoma.

PCYC closed Monday's trading at $76.76, up 1.60%.

Canadian clinical stage company Quest PharmaTech Inc. (QPT.V) has signed an exclusive license agreement with University of California at Los Angeles to develop and market anti-PSA IgE technology for the treatment of cancer. PSA is a tumor-associated antigen, associated with prostate cancer.

In preclinical studies, the immunotherapeutic IgE has demonstrated the potential ability to selectively open the circulation which may improve the ability of cytotoxic therapy to reach cancers and activate specific cellular immune responses directed against PSA originating in the tumor.

Sanofi's (SNY) Genzyme unit announced Monday that its once-daily, oral AUBAGIO 14 mg has been approved in Argentina as a new treatment for patients with relapsing forms of multiple sclerosis. This is the first approval for the drug in Latin America.

AUBAGIO is already approved in both the United States and Australia, with additional marketing applications under review by regulatory authorities around the world.

SNY closed Monday's trading at $51, up 0.67%.

Spectrum Pharmaceuticals Inc. (SPPI) has initiated a phase II study of its drug candidate, SPI-2012, for the treatment of chemotherapy-induced neutropenia. Spectrum has global rights for SPI-2012 except for Korea, China, and Japan. The global market for chemotherapy-induced neutropenia is estimated to be worth over $5 billion.

SPPI shed 1.39% to close Monday's trading at $7.07.

Theratechnologies Inc. (TH.TO) now holds 100% of the commercialization rights for its drug Tesamorelin in Europe, Russia, South Korea, Taiwan and certain Asian countries, following the termination of the distribution and licensing agreement with Ferrer Internacional S.A.

Tesamorelin is approved for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy.

by RTTNews Staff Writer

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