摘要:

Pralmorelin [GPA 748, GHRP 2, growth hormone-releasing peptide 2, KP-102 D, KP 102 LN] is an orally active, synthetic growth hormone-releasing peptide from a series of compounds that were developed by Polygen in Germany and Tulane University in the US.Researchers at Tulane University led by Dr Cyril Bowers synthesised a series of small highly active peptides ranging in size from 3–5 amino acids or partial peptides that were suitable for a variety of administration formats (subcutaneous, buccal, oral, depot). These peptides mimic the actions of ghrelin, a 28 amino acid octanoyl peptide that regulates the release of growth hormone (GH), and may play an important role in bone and muscle growth, food intake and possibly improve recovery from injury.The use of pralmorelin as a diagnostic agent for GH deficiency is based on its ability to markedly increase plasma levels of GH in healthy subjects irrespectively of gender, obesity or age. However, in patients with GH deficiency, the effect of pralmorelin on GH levels is significantly lower compared with healthy controls. Analysis of the receiver-operating characteristics curve provided the cut-off threshold value for the GH peak of 15.0 µg/L for the identification of patients with GH deficiency from those of healthy controls.Kaken acquired worldwide manufacturing and marketing rights to pralmorelin, and then sublicensed it to Wyeth (formerly American Home Products) for the US and Canada. Kaken retains rights to pralmorelin in Japan. On 11 March 2002 American Home Products changed its name and the names of its subsidiaries Wyeth-Ayerst and Wyeth Lederle to Wyeth.Kaken also granted exclusive sublicense options in Africa, Australia, Europe, Latin America and New Zealand to unspecified partners.Pralmorelin as KP-102 D [KP-102D] is currently awaiting approval in Japan as a diagnostic agent for hypothalamo-pituitary function. It is planned to be launched in Japan for this indication in 2004. Pralmorelin is also undergoing phase II clinical trials with Kaken in Japan for short stature (pituitary dwarfism) as KP-102 LN [KP-102LN]. Its launch for the treatment of short stature is planned for 2009 (Kaken, Annual Report 2003).The agent was undergoing phase II trials in the US for the treatment of GH deficiency with Wyeth; however, it appears that its development was discontinued.Tulane University was granted a US Patent (6,468,974 issued in October 2002), as well as patent protection in Europe and other countries for a series of synthesised GH-releasing peptides.

ISSN:1174-5886    

出版商:ADIS    

年代:2004

数据来源: ADIS

摘要:

RIGScan® CR49, a125I-labelled CR monoclonal antibody directed against the tumour-associated antigen TAG-72, is undergoing development with Neoprobe for the intraoperative detection of metastatic colorectal cancer.The Neoprobe's proprietary RIGS®(radioimmunoguided surgery) technology combines an injectable radiolabelled cancer-targeting agent and hand-held radiation detection probe that emits an audible tone when located tissue has accu-mulated a significant amount of the radioactive agent. Neoprobe's RIGS®technology also includes a patented surgical method providing surgeons with real-time information to locate tumour deposits that can not be detected by other conventional methods.The RIGS®technology has been evaluated in late clinical studies for the detection of adenocarcinomas including primary colorectal, gastrointestinal, breast, ovarian, pancreatic, prostate and neuroendocrine/endocrine.Neoprobe signed an option agreement for its first-generation RIGScan®compound, RIGScan®CR, with OncoSurg Inc. (formerly NuRigs Ltd). The second-generation humanised RIGScan®CR agent was also optionally licensed to OncoSurg Inc.In 1997, Neoprobe filed for approval with the US FDA and the EMEA for RIGScan® CR for the intraoperative detection of metastatic colorectal cancer. Both regulatory agencies have requested additional clinical data.On 19 April 2004, Neoprobe announced that it had met with the US FDA to discuss its position on submitting additional clinical information in response to the FDA's questions regarding the Biologic Licence Application (BLA) for RIGScan® CR49. The company provided the FDA with new information related to a survival differential for patients whose colorectal cancer was evaluated with RIGScan® CR49. The information was not available at the time of the BLA's submission in 1997. The agency indicated that it would consider accepting survival data from one of the two phase III trials, NEO2-14, but not from another trial NEO2-13, as supportive data for a prognostic indication for colorectal cancer. The FDA also clarified that two well controlled studies were required for approval, and indicated that Neoprobe needed to complete an additional confirmatory phase III study for a prognostic indication in colorectal cancer.[1]In its Annual Report 2002, Neoprobe stated that it had been working to secure a partner for further development of its proprietary RIGS®technology. The company intends either to find a development partner or sell or licence out their RIGS®assets if the partner is not found.

ISSN:1174-5886    

出版商:ADIS    

年代:2004

数据来源: ADIS

摘要:

WF 10 [TCDO, Oxoferin®, Immunokine™, Macrokine™] is a 1 : 10 dilution of tetrachlorodecaoxide formulated for IV delivery. It was developed by Oxo Chemie in Switzerland as an adjunctive therapy to combination antiretroviral and opportunistic infection prophylaxis regimens in AIDS patients. WF 10 specifically targets macrophages.Oxo Chemie has worldwide patent rights to WF 10 and Dimethaid Research has an exclusive licence for marketing and distribution in Canada. In May 2002, Oxo Chemie was acquired by Dimethaid Research.Oxo completed a trial in 72 cervical cancer patients undergoing radiation therapy in 1989. Results from this trial demonstrated complete remission in 75% of patients receiving WF 10. A follow-up placebo controlled trial in 1996 produced similar results.WF 10 has received regulatory approval in Thailand for postradiation cystitis following a trial completed in 1998 in 20 patients following radiation treatment for cervical carcinoma. This authorisation also allows limited availability of WF 10 at the physician's request in Germany. WF 10 is also available under Health Canada's Special Access Program.Oxo Chemie has completed a controlled randomised, crossover study in France in 1991 that examined the effects of 103 patients with acute radiation dermatitis and radiation- or chemotherapy-induced mucositis. Results demonstrated that WF 10 significantly improved lesions and accelerated recovery without side effects.Topical tetrachlorodecaoxide in a less concentrated formulation (1 : 55) is marketed in many countries as Oxoferin®for wound healing. WF 10 is approved for use in Thailand under the name IMMUNOKINE™ in patients with postradiation chronic inflammatory disease including cystitis, proctitis and mucositis.In July 2003, the European examiners informed Oxo Chemie that they intend to grant the company additional patents to the technology platform that supports WF 10, extending the European protection granted in 1992 to cover a much broader range of diseases. The patents will be granted in Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Liechtenstein, Luxembourg, Monaco, the Netherlands, Portugal, Spain, Sweden, Switzerland and the UK. Patent claims cover potential treatment for autoimmune disease, organ transplant or graft rejection, lymphoma and inflammation manifested as hepatitis or chronic obstructive pulmonary disease.

ISSN:1174-5886    

出版商:ADIS    

年代:2004

数据来源: ADIS