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pharmafile | February 28, 2008 | News story | Sales and Marketing |Â Â Â
Algeta to initiate US clinical trials for prostate cancer drug
Cancer therapeutics company Algeta has said that it will commence US clinical development of Alpharadin in hormone refractory prostate cancer or HRPC patients.
An initial Phase I pharmacokinetics, biodistribution and dosimetry study (BC1-08) with Alpharadin in HRPC patients with skeletal metastases will be conducted at the Memorial Sloan-Kettering Cancer Center in New York. This US trial will further expand the information obtained in a similar Phase I study (BC1-05) conducted at the Royal Marsden Hospital in London, for which patient enrolment has recently been completed.
Algeta has filed its investigational new drug application for its lead product Alpharadin with the FDA in December 2007. The statutory 30 day consultation period was extended by the FDA for a further 30 days by agreement with the company and the IND has now been cleared by the FDA without any objections being made to the application.
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Bionovo's breast cancer drug shows tolerability at higher doses
Bionovo has said that the higher doses of its innovative breast cancer drug candidate, BZL101 was well tolerated in an ongoing Phase I/II trial.
As a result, the company will be extending the dose escalation portion of the study longer than previously communicated.
Mary Tagliaferri, Bionovo's president and chief medical officer, said: "As a result of this positive news, we will continue the dose escalation, so long as we continue to see favorable tolerability and safety, after which we will transition to the full Phase II study component."
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ConjuChem initiates Phase II study of diabetic drug
ConjuChem Biotechnologies has initiated dosing in its Phase II clinical study for the treatment of Type 2 diabetes using the company's proprietary PC-DAC:Exendin-4 compound. The study is the first of two Phase II studies that the company plans to conduct concurrently.
This Phase II trial, a randomized, double-blind, placebo-controlled, multiple dose study, will evaluate the efficacy and safety of three months of weekly injections of PC-DAC:Exendin-4 in patients with Type 2 diabetes not adequately controlled by metformin monotherapy. The trial will enroll 90 patients with 30 patients randomized to one of three parallel treatment groups: a 1.5mg fixed weekly dose group, a group receiving a 1.5mg weekly dose titrating to 2mg at the fifth week, and a placebo group.
A second Phase II trial is also planned which will be a randomized, double-blind, placebo-controlled, multiple dose study, to evaluate the efficacy and safety of three months treatment with PC-DAC:Exendin-4 in Type 2 diabetes patients not adequately controlled by metformin monotherapy. This trial is designed to explore the efficacy and safety profile of twice-weekly titration and maintenance dosing and is expected to begin later in the first quarter of 2008.
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LifeCycle Pharma launches cholesterol drug in US
LifeCycle Pharma or LCP has launched its first product, the cholesterol lowering drug for the treatment of hyperlipidemia and hypertriglyceridemia, under the name Fenoglide in the US. Fenoglide will be marketed by its partner Sciele Pharma.
Fenoglide will be the lowest dose of fenofibrate available for patients. Fenoglide will be offered in 40mg and 120mg strength tablets. Fenoglide utilizes LCP's unique MeltDose technology, a clinically validated reformulation technology, designed to provide enhanced absorption and greater bioavailability of the drug.
Fenoglide will be marketed by Sciele Pharma's more than 400 sales representatives across its diabetes and cardiovascular sales force teams.
According to the agreement with Sciele Pharma, LCP will receive tiered royalty payments on product sales and may also receive milestone payments of up to $8 million when certain sales targets are met.
Patrick Fourteau, CEO of Sciele Pharma, said: "We expect the launch of Fenoglide, the lowest dose fenofibrate available to patients, will enable us to increase our share of the fenofibrate market, which is one of the fastest growing areas of the cardiovascular market."
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