Clinical Intelligence

ViiV Healthcare begins phase III dolutegravir/rilpivirine program for HIV maintenance therapy

Thursday, May 7, 2015

ViiV Healthcare has started a phase III clinical trial program to evaluate the safety and efficacy of dolutegravir (Tivicay) and rilpivirine (Edurant) as maintenance therapy for adult patients with HIV. The phase III program comprises two replicate studies evaluating 48 week viral suppression with a two drug regimen combining an integrase inhibitor (dolutegravir) and a non-nucleoside reverse transcriptase inhibitor (rilpivirine) in patients with HIV who already have achieved viral suppression with a three drug regimen.

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AbbVie’s Venetoclax receives FDA Breakthrough Therapy designation for CLL

Thursday, May 7, 2015

AbbVie has announced its investigational medicine venetoclax, an inhibitor of the B-cell lymphoma-2 (BCL-2) protein that is being developed in partnership with Genentech and Roche, has been granted Breakthrough Therapy designation by the FDA for the treatment of chronic lymphocytic leukemia (CLL) in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation.

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CytRx’s Aldoxorubicin shows improved QoL in chemotherapy resistant cancers

Monday, May 4, 2015

CytRx, a biopharmaceutical R&D company specializing in oncology, has announced an interim analysis from its two ongoing phase Ib aldoxorubicin combination studies pairing aldoxorubicin with either gemcitabine or ifosfamide. Both studies combine standard doses of gemcitabine or ifosfamide with escalating doses of aldoxorubicin. The combinations appear to be well-tolerated, and even at the lowest dose level of aldoxorubicin (170mg/m2), impressive tumor responses have been observed so far in patients with bone cancer (osteosarcoma) and a variety of soft tissue sarcomas. As such, aldoxorubicin has the potential when used in combination with other cancer agents to become an important new weapon against chemotherapy resistant cancers.

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PTC Therapeutics’ cancer stem cell program targeting BMI1 enters phase I

Thursday, April 30, 2015

PTC Therapeutics has announced that its oncology program targeting BMI1, a protein linked to drug-resistant cancers, has entered a phase I study in patients with advanced solid tumors. The open-label, first-in-human study will investigate the safety and pharmacokinetics of PTC596, an orally available small molecule. PTC’s BMI1 program is supported by a collaboration with the Wellcome Trust.

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Benitec Biopharma doses fifth patient, initiates additional trial site for hepatitis C trial

Thursday, April 30, 2015

Benitec Biopharma, a Sydney, Australia-based biopharmaceutical company focused on providing potentially curative therapies with its proprietary gene-silencing technology called ddRNAi or “expressed RNAi,” has doesed the fifth patient in the company’s first-in-man, phase I/IIa dose escalation clinical trial of TT-034 for hepatitis C virus (HCV) infection at the Duke Clinical Research Unit. The fifth patient is the third and final patient to be dosed in cohort two.

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Mitotech releases positive phase II data of SkQ1 for dry eye

Friday, April 24, 2015

Mitotech, a Luxembourg-based clinical-stage biotechnology company developing novel antioxidant molecules targeting mitochondria, has achieved significant positive results in its U.S. phase II clinical trial of SkQ1 compound in patients with moderate to severe dry eye syndrome. SkQ1 is a small molecule engineered specifically for reducing oxidative stress inside mitochondria, which proved to be effective in a topical ophthalmic formulation for treatment of dry eye syndrome.

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