News roundup from Datamonitor
pharmafile | August 17, 2007 | News story | Research and Development, Sales and Marketing |
Cel-Sci secures manufacturing facility for Multikine cancer drug
Cel-Sci has entered into an agreement with a biomedical real estate group under which it has acquired long-term use of a dedicated manufacturing facility for its experimental cancer drug Multikine. The financial value of the deal is about $15 million.
The manufacturing facility is located near Baltimore, Maryland. Once fully built out to Cel-Sci's specifications, the facility will produce Multikine for both its phase III clinical trials for head and neck cancer, as well as other cancers, and following marketing approval, for sale.
Cel-Sci has leased the facility for 20 years, with options to extend the lease or purchase the facility at a later time. BioRealty, a privately held real estate firm specialising in the biomedical sector, will provide development management services and funding for the build-out of this facility, which, once fully built out, will be able to supply more than $1 billion worth of drugs, according to Cel-Sci.
The manufacturing facility will allow the company to produce Multikine, a biologic, in the same manufacturing facility for phase III clinical trials as for commercial production. Cel-Sci says regulatory authorities prefer to see biologics such as Multikine produced in the same manufacturing facility for phase III clinical trials and the sale of the product because this arrangement helps to ensure that the drug lots used to conduct the trials will be consistent with those that will be marketed subsequent to approval.
Geert Kersten, chief executive officer of CEL-SCI commented: "Manufacturing biologics is such an expensive endeavour that most biotech companies partner with larger companies, and in the process give up their marketing rights. The funding with BioRealty will allow us to keep the marketing rights, thereby giving our shareholders the greatest value creation. Now that the significant hurdle of manufacturing has been tackled, we are able to focus on getting Multikine through phase III, and ultimately to patients."
In phase II clinical trials, Multikine was shown to be safe and well-tolerated, and improved patients' overall survival by 33% at a median of three and a half years following surgery. The FDA gave the go-ahead for a phase III clinical trial with Multikine in January 2007 and granted orphan drug status to Multikine in the neoadjuvant therapy of squamous cell carcinoma (cancer) of the head and neck in May 2007.
Related links:
CEL-SCI Corporation: LSA company report
Pipeline Insight: Therapeutic Cancer Vaccines – A turbulent path from bench to bedside
Innovations in Cancer: Novel therapeutics, new diagnostics and future R&D strategies
Commercial Insight: Top 20 Cancer Therapy Brands – Sales of targeted therapies
CombinatoRx begins Phase IIa diabetes treatment trial
CombinatoRx has dosed the first patient in a phase IIa proof-of-concept clinical trial in type II diabetes with CRx-401, a novel insulin sensitiser designed to provide anti-diabetic activity without promoting weight gain.
CombinatoRx says it selected CRx-401 for clinical evaluation based on preclinical data demonstrating decreased fasting glucose and insulin resistance without weight gain.
According to the company, CRx-401 offers the potential to achieve and maintain multiple treatment goals including reducing hyperglycemia, reducing elevated triglycerides (TG), and elevating high density cholesterol (HDL), the "good" cholesterol".
The clinical trial is a multi-centre, randomised study evaluating the safety and efficacy of CRx-401, as an add-on therapy in type II diabetes, in comparison to bezafibrate alone. Approximately 80 subjects with type II diabetes who are poorly controlled on metformin are planned to be enrolled.
Patients will be randomised in a 1:1 ratio to CRx-401 (400mg bezafibrate sustained-release and 250mg diflunisal) or 400mg of bezafibrate sustained-release plus placebo. Patients will remain on their pre-existing stable dose of statins and low dose aspirin. Endpoints include fasting plasma glucose and insulin resistance.
Related links:
CombinatoRx Inc: LSA company profile
The Diabetes Market Outlook to 2011
Non-insulin Antidiabetics – Type 2 diabetes unlikely to develop into a switch market
BrainStorm on the road to clinical studies in Parkinson's disease
BrainStorm Cell Therapeutics has reported preliminary results from its first safety supporting experiment for Parkinson's disease treatment research.
On February 8, 2007, in laboratories at the University of Navarra, Pamplona, Spain, professor Jose Obeso transplanted the subject, a healthy monkey, with BrainStorm's human bone marrow derived mesenchymal stem cells. The stem cells had been induced to differentiate into neurotrophic factor-producing cells, according to the protocol developed at the company's laboratories in Israel.
The monkey was treated daily with cyclosporine to prevent rejection of the human originating cells by its immune system, and was monitored for a variety of parameters for a period of three months. Throughout this phase, the monkey appeared well and in good health, with a usual appetite, and with no apparent change in physical and behavioral parameters. Blood tests, an MRI of the monkey's brain and an autopsy examination of the internal organs were also found to be normal.
Additionally, brain tissues from the monkey were examined by Professor Jeffrey Kordower, from Rush University, Chicago. A few human originating cells were detected in sections of the monkey's brain by staining the sections with an antibody, which can distinguish between the monkey's own brain cells and the human transplanted cells.
The human transplanted cells were surrounded by macrophages, which may indicate a reaction of the monkey's immune system to the transplanted human cells and their initial rejection. BrainStorm said that its actual approach would involve autologous transplantation (i.e., the use of the patient's own bone marrow-derived stem cells). With this strategy, no rejection is expected and there will be no need to suppress the immune system by medications that often cause severe side-effects.
"The recent financing the company has received will, with G-d's help, allow BrainStorm to move forward with the preparations necessary toward carrying out Phase I/II clinical trials in patients with Parkinson's disease, and providing the funding and support needed to conduct additional safety pharmacology studies, such as toxicology," commented Chaim Lebovits, president of BrainStorm.
Two additional normal monkeys recently underwent transplantation in Pamplona with BrainStorm's human stem cells. The monkeys will also be monitored for a period of three months for collection of additional data; so far, the monkeys are in good health.
Related links:
BrainStorm Cell Therapeutics Inc: LSA company profile
Parkinson's Disease – Review of Key Commercial Opportunities in the Symptomatic Treatment Market
Parkinson's Disease and Restless Legs Syndrome – Reformulations set to drive near-term growth
Icagen forms alliance with Pfizer
Icagen has entered into a collaboration and licensing agreement with Pfizer for the discovery, development and commercialisation of compounds which modulate three specific sodium ion channels as new potential treatments for pain and related disorders.
Under the terms of the agreement, Icagen and Pfizer will combine resources to identify compounds that target these three ion channels in a global R&D collaboration. The companies will form a joint research committee to monitor and oversee the collaboration.
Pfizer will fund all aspects of the collaboration including the research and preclinical development efforts at Icagen and will have exclusive worldwide rights to commercialise products that result from the collaboration. In addition, in connection with the collaboration Pfizer will make an equity investment in Icagen.
The ion channel targets included in the collaboration are important in the generation of electrical signals in nerve fibres that mediate the initiation, transmission and sensation of pain. In preclinical studies, compounds identified by Icagen have demonstrated efficacy in pain models. Icagen says it has also established a broad portfolio of intellectual property in this area, covering multiple promising compounds targeting sodium channels.
"Given that there are three different ion channel targets in the collaboration, we believe that there is a possibility for at least three unique products to emerge from this joint effort," said P. Kay Wagoner, president and CEO of Icagen.
Under the terms of the agreement, Pfizer will provide $38 million in committed funding to Icagen over the first two years of the collaboration, including an initial upfront licence fee of $12 million, up to $15 million through an equity commitment, and R&D funding. Additionally, Icagen is eligible to receive $359 million in research, development, regulatory and commercialisation milestones for each product.
Related links:
ICAgen Inc: LSA company profile
Pfizer Inc: LSA company profile
Neuropathic Pain – A Plethora of Patient Segmentation and Product Differentiation Opportunities
Pipeline Insight: Breakthrough Pain – Fast-acting players will capture majority market share
