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Product roundup from Datamonitor

Published on 04/06/07 at 10:03am

Celsion completes enrolment in phase I liver cancer study

Celsion has completed its phase I dose escalation study, using ThermoDox, to treat non-resectable liver cancer.

The study, which was conducted under a cooperative R&D agreement, was performed at the National Cancer Institute (NCI) of the National Institutes of Health.

In the study, a total of 24 primary and metastatic liver cancer patients, with up to four lesions ranging from three to seven centimeters, were treated with ThermoDox in combination with radiofrequency ablation at doses ranging from 20 to 60mg/m2.

Enrolment in the study has been completed, and clinical data is currently being assembled for analysis and eventual submission for the FDA. While the phase I study was designed to determine the maximum safe dose and safety profile of ThermoDox, additional analyses will be undertaken to evaluate any clinical effects achieved during the study, Celsion said.

Michael Tardugno, Celsion's president and CEO, commented: "Completion of the liver cancer phase I dosing escalation study represents another milestone in our ThermoDox development programme and is consistent with our timelines to initiate our phase III registrational study for primary liver cancer later this year."

Celsion has licensed the global rights to the temperature-sensitive liposome technology from Duke University where ThermoDox is also being used in a phase I clinical study of patients with recurrent breast cancer on the chest wall under the care of Dr Kim Blackwell, the principal investigator.

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CeNeRx to develop PharmaNess cannabinoid portfolio

PharmaNess Neuroscience has licenced the rights to a series of novel cannabinoid compounds that selectively target the CB1 and CB2 cannabinoid receptors to US biopharmaceutical company CeNeRx.

Under the terms of the agreement, CeNeRx has been granted an exclusive worldwide licence to develop, manufacture and commercialise the PharmaNess cannabinoid portfolio, currently including over a dozen preclinical compounds.

According to CeNeRx, these compounds may have broad utility, including cannabinoid agonists for pain, glaucoma and other CNS-related disorders, and cannabinoid antagonists for obesity. The companies' collaboration also includes drug discovery efforts aimed at further expanding their joint cannabinoid portfolio.

"Gaining access to this rich pipeline of cannabinoid compounds represents a unique opportunity for CeNeRx," said Barry Brand, the company's CEO. "These compounds work via a novel, yet well-described mechanism-of-action, have excellent selectivity and could potentially be applied to large indications with significant unmet need."

Under the terms of the agreement, PharmaNess will receive an upfront payment from CeNeRx, as well as development milestones. PharmaNess will also receive royalties on global sales of any commercialised cannabinoid compounds.

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HGS, GSK initiate second phase III trial of lupus drug

Human Genome Sciences has started dosing in its second phase III clinical trial of its novel compound LymphoStat-B in patients with active systemic lupus erythematosus.

LymphoStat-B, a human monoclonal antibody, is being developed by Human Genome Sciences (HGS) and GlaxoSmithKline under a definitive development and commercialisation agreement entered into in August 2006.

The trial is being conducted primarily in Asia, South America and Eastern Europe. Meanwhile, dosing in the first phase III trial began in February 2007, and is being conducted primarily in North America and Europe.

The first and second phase III trials will both test the safety and efficacy of 1 mg/kg and 10 mg/kg doses of LymphoStat-B against a placebo.

HGS said that it believes LymphoStat-B could address the significant medical need of patients suffering from systemic lupus erythematosus (SLE), a chronic, life-threatening autoimmune disease.

Professor Sandra Navarra, a principal investigator and head of rheumatology at the University of Santo Tomas, Manila, Philippines, said: "The results of previous studies suggest that LymphoStat-B significantly reduced SLE disease activity in serologically active patients. We look forward to further evaluation of LymphoStat-B in larger numbers of patients in the phase III trials."

H Thomas Watkins, president and CEO of HGS, added: "These trials, assuming that they are successful, will provide the pivotal data to support global marketing applications for LymphoStat-B."

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Rexahn to take kidney cancer drug into phase II

US biopharmaceutical company Rexahn Pharmaceuticals has received FDA approval to initiate a phase II trial for its lead oncology compound Archexin in patients with renal cell carcinoma, the most common form of kidney cancer.

Rexahn, which specialises in discovering, developing and commercialising treatments for cancer among other diseases, said that enrolment for the phase II trial of Archexin, a first-in-class signal inhibitor, is expected to begin in Q3 2007.

The phase II trial will be a non-blind, multi-center study. According to Rexahn, the trial is designed to assess the efficacy of Archexin in patients with advanced renal cell carcinoma (RCC) who have failed previous treatment or are unwilling or unable to be treated with standard systematic line therapy.

Chang Ahn, chairman and CEO of Rexahn, commented: "Archexin is designed to disrupt the signals responsible for cancer progression, and as such, may someday offer patients a more targeted, less toxic therapeutic approach to cancer treatment. We look forward to moving this compound ahead in its clinical development."

According to Rexahn, in both preclinical and phase I clinical trials, Archexin demonstrated effectiveness at inhibiting the proliferation of various cancer cells at nanomolar concentrations and regulating the growth of tumours.

Archexin was granted an "orphan drug designation" for kidney, stomach, ovarian, pancreas and brain cancers by the FDA in December 2004.

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Ranbaxy acquires 13 dermatology products from Bristol-Myers

Ranbaxy Laboratories has acquired the US rights to a group of 13 dermatology products from Bristol-Myers Squibb.

These products have been present in the market for more than 10 years and have been utilised in the treatment of acne, dermatitis, psoriasis, fungal infections and scabies. The US dermatology market value is estimated at $10 billion and has experienced growth of 10% per annum.

Ranbaxy already has a strong presence in the acne segment of the dermatology market with its best-selling product, Sotret Isotretinoin Capsules USP, for the treatment of severe recalcitrant nodular acne. Sotret is the largest selling brand among the isotretinoin brands with a market-share in excess of 36%, according to IMS.

The company says the 13 acquired products have significant synergy and represent an opportunity towards building a "dermatology business" with a predictable revenue stream.

The brands will be sold in the US market under the Ranbaxy Laboratories label. Ranbaxy believes that incremental sales from the 13 products can be generated through active promotion.

Venkat Krishnan, vice president and regional director for Ranbaxy in North America, said: "This business opportunity also creates a broader platform for the introduction of value added line extensions and additional brands as our involvement and commitment to dermatology expands. It underscores our strategy of pursuing inorganic growth opportunities to complement internal growth."

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