摘要:

IDM 1 is a product composed of MDX 210 in association with Monocyte-derived Activated Killer (MAKŒ) cells. MDX 210 is a bispecific monoclonal antibody against Her-2 conjugated to a TriggerŒ anti-CD64 antibody that has been developed by Medarex. It directs and activates effector cells, including monocytes, macrophages and activated (by cytokines) neutrophils.IDM 1 is in a phase III trial with IDM (Immuno-Designed Molecules) in Europe and North America for treatment of patients with ovarian cancer. The company plans to enrol 280 patients with ovarian cancer into this trial and will continue the trial for 3.5 years. IDM and the Peter MacCullum Cancer Institute of Melbourne signed a collaboration agreement in February 2001 to extend the number of sites available for the company's phase III trial in ovarian cancer. The Australian Health Authorities have given their permission to commence the trial there, and the study is currently underway.In October 2001, Canadian health authorities gave approval for a phase III trial of IDM 1 to begin in Canada. The trial will be carried out in patients from Canada and North America who have stage III ovarian cancer. IDM-Biotech, a Canadian subsidiary of IDM, will conduct the trial in collaboration with the McGill University's Lady Davis Institute for Medical Research, Montreal.

ISSN:1174-5886    

出版商:ADIS    

年代:2002

数据来源: ADIS

摘要:

Iseganan [IB 367, protegrin IB 367,] is a synthetic protegrin (a lytic peptide originally isolated from pig leucocytes) that is being developed by IntraBiotics Pharmaceuticals as a rinse for the treatment and prevention of oral mucositis. Oral mucositis is a common side effect of cancer therapies, in which the rapidly growing epithelial cells that line the mouth are destroyed. Iseganan targets Gram-negative and -positive bacteria andCandida albicans,and destroys these pathogens by attaching to their lipid membranes; this sterilises the oral environment and prevents the likelihood of secondary infection if the atrophied mucosa is traumatised. Iseganan has a unique mechanism of action, exerting its antimicrobial effects by disrupting bacterial cell membranes. Protegrins act rapidly and resistance to iseganan has not been observed in clinical studies to date.Pharmacia & Upjohn had licensed worldwide exclusive rights to iseganan, except in the US, and was collaborating with IntraBiotics Pharmaceuticals for development and marketing of the drug for the treatment of oral mucositis. However, after completion of a phase I study, the collaborative agreement between Pharmacia & Upjohn and IntraBiotics was terminated at the end of 1999 and IntraBiotics reacquired global rights to iseganan. Financial terms of the reacquisition of rights were not disclosed. This now allows IntraBiotics to fully exploit the potential of iseganan for additional infectious disease indications. IntraBiotics has completed a phase II study of iseganan in the US for the prevention and treatment of oral mucositis in patients undergoing ablative chemotherapy prior to bone marrow transplantation. A phase III trial in patients receiving high doses of chemotherapy frequently responsible for severe oral mucositis has also been completed, but did not meet its primary end-point because of a dispensing error and consequent reduction of statistical power. A second phase III study has commenced evaluating iseganan in patients with head and neck cancer who are undergoing radiation therapy; it is expected to be completed the 2nd quater of 2002. An additional phase III trial in patients undergoing high-dose chemotherapy commenced in the 4th quarter of 2001, with completion expected by the 4th quarter 2002. The US FDA has granted fast-track status to IB 367 rinse.In a media release dated 18 December 2000, Intrabiotics announced the start of a phase IIa clinical trial for iseganan rinse, for the prevention of ventilator-associated pneumonia. According to preliminary results announced during March 2001, iseganan rinse was well tolerated by intubated patients and demonstrated antimicrobial activity in the mouth, the site of drug application. The study enrolled 16 patients at 8 sites in the US. It appears that IntraBiotics has signed an agreement with Polypeptide Laboratories A/S of Denmark for the development of a manufacturing process and for the supply of iseganan.IntraBiotics Pharmaceuticals has also completed a phase I clinical trial of iseganan aerosol for the treatment of respiratory infections caused by resistant strains ofStaphylococcus aureusandPseudomonas aeruginosain cystic fibrosis patients. The phase I randomised, controlled, double-blind study was conducted at 4 cystic fibrosis centres in the US. Patients were administered increasing doses of iseganan aerosol to determine the safety and tolerability of the inhaled formulation. IntraBiotics announced in December 2000 that data from the phase I study supports further development of iseganan in this indication. The company expects to begin a phase IIa clinical trial.Iseganan is also undergoing phase I investigation for the treatment of mycoses in the US.

ISSN:1174-5886    

出版商:ADIS    

年代:2002

数据来源: ADIS

摘要:

Oxycodone/ibuprofen, a combination of opioid mu receptor agonist and cyclo-oxygenase inhibitor, is being developed by Forest Laboratories as an analgesic agent. Forest Laboratories has completed phase III clinical studies with the agent in the USA.The NDA filing for oxycodone/ibuprofen is anticipated by the end of 2001.Figure. Oxycodone/ibuprofenOxycodone/ibuprofen was originally developed by DuPont Pharmaceuticals (formerly DuPont Merck), licensed exclusively to BTG (UK) and subsequently licensed to Forest Laboratories for development worldwide. On October 1, 2001, DuPont Pharmaceuticals was acquired by, and integrated into, Bristol-Myers Squibb.The patent on the combination expires in 2005, but is likely to be extended.

ISSN:1174-5886    

出版商:ADIS    

年代:2002

数据来源: ADIS

摘要:

Pitavastatin [nisvastatin, itavastatin, NK 104, NKS 104, P 872441] inhibits HMG-CoA reductase, a rate-limiting key enzyme of cholesterol synthesis pathway. It originated with Nissan Chemical Industries and is now in joint development with Kowa in Japan. Phase III clinical trials have been completed in Japan for the treatment of hyperlipidaemia and an application for regulatory approval as a 2mg dose has been filed in this country. Phase III trials are underway in Europe (with Negma, now a subsidiary of Novartis) and phase II trials are scheduled to begin in the US (with Sankyo) in 2001. Novartis expects to file for regulatory approval in Europe in 2005. Sankyo has licensed pitavastatin for co-marketing in Japan and has also obtained exclusive development and marketing rights in the USA. In the USA, Novartis and Nissan hold certain patent rights relating to pitavastatin. Negma licensed partial European rights to pitavastatin. In April 2001, Novartis secured semi-exclusive European, African and Canadian rights to pitavastatin by acquiring the privately held French company Hazal Finance and its affiliate. Kowa has the right to co-market pitavastatin in European Union countries. In October 2001, Recordati announced it had signed a semi-exclusive licensing agreement for pitavastatin with Kowa for Italy. In February 2001, SkyePharma PLC announced it had an agreement with Kowa to provide pitavastatin for the US and European phase III studies; the clinical batches will be manufactured at SkyePharma's production facility near Lyon, France.Figure. Pitavastatin [nisvastatin, itavastatin, NK 104, NKS 104, P 872441]

ISSN:1174-5886    

出版商:ADIS    

年代:2002

数据来源: ADIS

摘要:

Ramoplanin [A 16686, A 16686A, MDL 62198], originated by Biosearch Italia, is a topical glycolipopeptide antibacterial agent derived fromActinoplanesspp. with bactericidal activity primarily against Gram-positive organisms. Ramoplanin kills microbes by blocking bacterial cell wall synthesis at a site that is different from those targeted by the β-lactams such as penicillin and the glycopeptides such as vancomycin. To date, laboratory studies have not encountered bacterial resistance with ramoplanin and no cross resistance has been observed between ramoplanin and the β-lactams or glycopeptides.Figure. Ramoplanin [A 16686, A 16686A, MDL 62198]Ramoplanin has potential for use in the treatment of vancomycin-resistant enterococcal infection, for which it has been granted fast-track status by the US FDA and given an Orphan Medicine designation by the European Commission. Other potential clinical uses under investigation are selective gut decontamination and eradication ofClostridium difficilefrom the bowels of patients with pseudomembranous colitis and eradication of nasal carriage of MRSA.A placebo-controlled phase II trial in 150 patients with hospital acquired vancomycin-resistantEnterococcus faecium(VREF) intestinal infections has been completed at eight centres in the USA. The study was terminated early after an independent Data Safety Monitoring Board (DSMB) determined there was sufficient evidence of effectiveness and safety to proceed with phase III trials. In mid-2000, IntraBiotics initiated a phase III trial of oral ramoplanin for the prevention of vancomycin-resistant enterococcal blood infection in the USA. Although the company hoped that the US phase III trials would be completed by 2001, it was announced in March 2001 that a delay of 1 year was expected because of difficulties in patient recruitment. A phase II trial of ramoplanin ointment to prevent hospital-based infections caused byStaphylococcus aureus, including MRSA, has been initiated. The goal of the phase II trial is to determine whether ramoplanin ointment can effectively eradicate nasal carriage ofS. aureusin human volunteers. Nine sites across the US will enroll a total of 250 volunteers who carryS. aureusin their nose. All volunteers will receive ramoplanin or placebo for 4 days and will be monitored for 90 days to evaluate nasal carriage of MRSA.In October 2001, Biosearch Italia licensed exclusive rights to oral ramoplanin in the US and Canada to Genome Therapeutics. The latter will be responsible for development of the drug, including funding of clinical trials, and will make a $US2 million initial payment, followed by up to $US8 million in milestone payments. Genome will also purchase bulkmaterial from Biosearch and pay royalties on product sales. US and Canadian rights to oral ramoplanin were previously licensed to IntraBiotics. As a follow-on to the delay in successfully completing the phase III trial of oral ramoplanin in VREF infections, Biosearch Italia renegotiated this licensing agreement. IntraBiotics relinquished North American rights for ramoplanin oral powder to BioSearch, but retained the rights to topical ramoplanin for this market. BioSearch Italia has also imposed an ultimatum on IntraBiotics for topical ramoplanin; if IntraBiotics does not begin clinical trials by March 2002, all rights will revert to BioSearch, which would then seek another partner.During February 2001 Biosearch Italia signed an agreement with an Italian subsidiary of Aventis (Aventis Bulk SpA) for the manufacture of ramoplanin. The latter will manufacture sufficient quantities of the drug for clinical development and its eventual launch in the US.

ISSN:1174-5886    

出版商:ADIS    

年代:2002

数据来源: ADIS

摘要:

Rimonabant [SR 141716, SR 141716A] is a neurokinin 3 antagonist and selective cannabinoid CB1 receptor antagonist developed by Sanofi. Inmid-1999, Sanofi merged with Synthelabo to form Sanofi-Synthelabo. In a rodent model, rimonabant has demonstrated memory-enhancing properties in preclinical trials, but commercial development in this indication does not appear to be actively ongoing.Figure. Rimonabant [SR 141716, SR 141716A]Rimonabant has entered phase III clinical studies for the treatment of obesity. In phase IIb clinical studies, patients with obesity receiving rimonabant achieved significant weight loss, and showed an excellent safety profile.Rimonabant reportedly at phase IIa for schizophrenia.

ISSN:1174-5886    

出版商:ADIS    

年代:2002

数据来源: ADIS

摘要:

Satraplatin [BMS 182751, BMY 45594, JM 216] is the lead compound of a series of orally-active platinum compounds. It was under joint development with Bristol-Myers Squibb, Johnson Mathey and the Institute of Cancer Research in the UK, however Johnson Mathey has discontinued development. In October 2001, NeoOncoRx gained the rights to develop and market satraplatin worldwide. NeoOncoRx plans to carry out a phase III trial in prostate cancer patients at the beginning of 2002.Figure. Satraplatin [BMS 182751, BMY 45594, JM 216]Clinical trials: satraplatin is currently undergoing phase III clinical trials in Europe and the US for the treatment of ovarian, non-small cell lung and small cell lung cancers. It is undergoing phase II trials in Canada for the treatment of cervical cancer, and phase II trials in the US for the treatment of prostate cancer. In addition, satraplatin is undergoing phase I clinical trials in Canada (in combination with cisplatin) and Japan for the treatment of cancer.

ISSN:1174-5886    

出版商:ADIS    

年代:2002

数据来源: ADIS

摘要:

All drugs appearing in the Adis R&D Profile Summary table have been selected based on information contained inR&D Insight™,1a proprietary product of Adis International. The information in the profiles is gathered from the world's medical and scientific literature, at international conferences and symposia, and directly from the developing companies themselves. The emphasis ofDrugs in R&Dis on the clinical potential of new drugs, and selection of agents for inclusion is based on products in late phase clinical development that have recently had a significant change in status.

ISSN:1174-5886    

出版商:ADIS    

年代:2002

数据来源: ADIS