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pharmafile | December 10, 2007 | News story | Research and Development |Â Â Â
Adventrx completes enrolment for breast cancer trial
Adventrx Pharmaceuticals has completed patient enrolment in its Phase II clinical trial of CoFactor for the treatment of advanced breast cancer.
The Phase II clinical trial is a single arm, multicenter study to evaluate the safety and efficacy of treatment with CoFactor plus 5-fluorouracil (5-FU) in advanced breast cancer patients who have failed anthracycline and taxane chemotherapies.
Patients are treated with CoFactor followed by 5-FU administered by IV bolus weekly for six weeks, with tumor and safety assessments every eight weeks.
The primary endpoint for the study is objective response rate as defined by response evaluation criteria in solid tumors (RECIST) criteria, and secondary endpoints are duration of response, progression free survival, overall survival and incidence and severity of adverse events, as defined by the National Cancer Institute (NCI) common terminology criteria. A total of 32 patients were enrolled in this study.
CoFactor is a folate-based biomodulator drug designed to replace leucovorin as the preferred method to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapeutic agent 5-FU.
Evan Levine, CEO of Adventrx, said: "Data on the primary endpoint in this study, along with overall survival data from our Phase IIb study and available data from our discontinued Phase III study, all of which we expect in the second quarter of 2008, will expand our understanding of CoFactor's safety and efficacy."
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BioAlliance acquires rights to pneumonia drug
BioAlliance Pharma has entered into an exclusive licensing agreement with Immtech Pharmaceuticals covering the European commercialization rights to pafuramidine maleate.
Under the agreement Immtech will receive an initial license fee of $3 million and up to an additional $13 million if pafuramidine achieves European regulatory approval and pricing milestones. Immtech will receive significant royalties on sales and may also earn two additional milestone payments linked to the turnover generated.
Furthermore, if BioAlliance elects to exercise the option to commercialize pafuramidine for malaria prophylaxis, it will start to share the clinical development costs for a Phase III trial which is due to start shortly.
Pafuramidine is currently in Phase III clinical trials in the US for the treatment of Pneumocystis Pneumonia in AIDS patients and human African trypanosomiasis.
Pafuramidine has orphan designation in the US. BioAlliance has also negotiated the grant of an option to sell pafuramidine in Europe for the prevention and treatment of malaria in travelers.
Dominique Costantini, CEO of BioAlliance, said: "We are pursuing the European growth strategy presented at the time of our fund raising by private placement in July, with the acquisition of late-stage development products such as pafuramidine."
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Caraco receives FDA approval for cardiovascular drug
Caraco Pharmaceutical Laboratories has received final approval from the FDA for the company's abbreviated new drug application for amlodipine besylate tablets, 2.5mg, 5mg, and 10mg.
Amlodipine is indicated for the treatment of hypertension, for the symptomatic treatment of chronic stable angina, and for the treatment of confirmed or suspected vasospastic angina. Amlodipine is the bioequivalent to Norvasc, a registered trademark of Pfizer.
Daniel Movens, CEO of Caraco, said: "This product marks our seventh final approval since June 30, 2007. We are evaluating the market place and internal production planning in an effort to monetize this approval as soon as possible. This will bring our total product selection to 43 different products represented by 92 various strengths."
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Rigel starts Phase I trial of asthma drug
Rigel Pharmaceuticals has reported that its corporate partner Pfizer has begun a Phase I clinical trial of an inhaled formulation of Rigel's small molecule syk kinase inhibitor, R343, for the treatment of allergic asthma.
Under the 2005 collaboration agreement, Rigel will receive a $5 million milestone payment from Pfizer for the commencement of this study. Pfizer retains exclusive rights to R343 and is responsible for its clinical development.
R343 will be delivered via the inhaled route using a dry powder inhaler and will initially be tested in healthy volunteers to evaluate its safety, dosing and pharmacodynamics.
Donald Payan, executive vice president and chief scientific officer of Rigel, said: "Developing an inhaled drug product that may address an important pathway in the allergic response causing asthmatic airway obstruction and tissue damage gives new hope to millions of asthma sufferers."
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Vivalis receives European patent for stem cell technology
France-based Vivalis has received a new European patent, relating to obtaining avian embryonic stem cells, from the European Patent Office.
This patent protects a process of obtaining avian embryonic stem cells modified through homologous recombination to express recombinant proteins of interest.
The new patent strengthens the company's portfolio of patents in the area of avian stem cells.
Franck Grimaud, president of the board of directors, Vivalis, said: "This will allow the company to continue to strengthen its intellectual property portfolio and consolidate its position as world leader in the field of avian stem cells."
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