摘要:

KMD 3213 [silodosin, KAD 3213] is an orally active α1-adrenoceptor antagonist under development with Kissei (Japan) for the treatment of dysuria associated with benign prostatic hyperplasia (BPH).Daiichi Pharmaceutical and Kissei are conducting phase III trials in Japan, while Kissei's US subsidiary, Kissei Pharma USA Inc., has completed early phase II trials with favourable results for the treatment of dysuria associated with benign prostatic hyperplasia (BPH). Kissei expects to file an NDA application in Japan in July 2004.Daiichi is also preparing a phase I trial in China with this compound for the treatment of dysuria associated with benign prostatic hyperplasia.According to Kissei's 2003 Annual Report, they are currently preparing to license out the development and marketing rights for KMD 3213 in Europe and North America.In March 2002, Daiichi predicted that KMD 3213 has the potential to reach peak sales of approximately JPY10 billion.

ISSN:1174-5886    

出版商:ADIS    

年代:2004

数据来源: ADIS

摘要:

Motexafin gadolinium [gadolinium (III) texaphyrin, gadolinium texaphyrin, Gd-Tex, GdT2B2, PCI 0120] is a radiosensitising agent developed for use in cancer therapy. It is cytotoxic in haematological malignancies by selectively localising in cancer cells that have high rates of metabolism. Motexafin gadolinium inhibits cellular respiration resulting in the production of reactive oxygen species and inducing apoptosis. It is being developed by Pharmacyclics in the US.Bulk motexafin gadolinium is supplied to Pharmacyclics by the US company, Celanese, through a manufacturing and supply agreement between the two companies.In June 2003, at the 39th Annual Meeting of the American Society of Clinical Oncology (ASCO-2003), the importance of having an agent for the treatment of brain metastases from lung cancer was highlighted. Results of a phase III study were presented that showed that motexafin gadolinium treatment was associated with a delay in time to neurological and neurocognitive progression in lung cancer patients. This was an important finding, as 46.6% of lung cancer patients already have brain metastases at the time of initial diagnosis, compared with only 2.7% of breast cancer patients. Brain metastases are also often the only site of metastatic disease in patients with lung cancer.[1]In December 2002, Pharmacyclics began a phase III trial of motexafin gadolinium in patients with brain metastases (brain cancer in phase table) from lung cancer in the US, Europe, Canada and Australia. The trial is known as the Study of neurologic progression with Motexafin gadolinium And Radiation Therapy (SMART) and will compare whole-brain irradiation with whole-brain irradiation plus motexafin gadolinium in 550 patients. The primary efficacy endpoint is time to neurological progression and the secondary endpoints are survival and neurocognitive function.[2]In January 2003, the US FDA completed its Special Protocol Assessment (SPA) of the SMART trial with a positive result and by June 2003, enrolment had begun.[3]In addition, phase I trials are underway in children with intrinsic pontine glioma and adults with head and neck, lung and pancreatic cancers. A phase II trial is also being conducted in the US in patients with glioblastoma multiforme. Enrolment in this trial has been completed and preliminary results have been reported.Pharmacyclics has completed enrolment and follow-up of adults in its pivotal phase III trial of motexafin gadolinium as a radiation sensitiser for the treatment of brain metastases. The trial was conducted at 35 centres in Europe, Canada and the US. Full results from this initial phase III trial were presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Florida, USA, held in May 2002. Pharmacyclics also announced in October 2002, at the 44th Annual Meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO), that motexafin gadolinium significantly prolonged time to neurological progression when added to whole brain radiation therapy and reduced the number of deaths in patients with brain tumour.Pharmacyclics announced in September 2000 that it has initiated two NCI-sponsored phase I trials conducted under a Cooperative Research and Development Agreement (CRADA) between Pharmacyclics and the NCI. The first trial, conducted in patients with stage IIIA non-small cell lung cancer, was designed to determine the safety of two different dosing regimens of motexafin gadolinium during preoperative radiotherapy after induction chemotherapy. The second study was designed to examine the use of motexafin gadolinium in combination with stereotactic Gamma Knife radiosurgery in patients with primary glioblastoma mutiforme.Two phase I clinical trials have also been conducted for the treatment of newly diagnosed glioblastoma multiforme at the UCLA Jonsson Comprehensive Cancer Center, USA. These phase I studies were sponsored by the NCI and were conducted under a CRADA with the NCI.Pharmacyclics has also completed multicentre US phase II clinical trials of motexafin gadolinium in patients with metastatic tumours of the brain who require whole brain radiotherapy.Motexafin gadolinium is in a phase II trial in patients with lymphomas and multiple myeloma in the US.[4]

ISSN:1174-5886    

出版商:ADIS    

年代:2004

数据来源: ADIS

摘要:

The photosensitiser rostaporfin [Purlytin™, SnET2, tin ethyl etiopurpurin, Sn(IV) etiopurpurin, PhotoPoint SnET2] was developed by Miravant Medical Technologies (USA) for use in the company's PhotoPoint™ photodynamic therapy. The therapy relies on low power, non-thermal light produced by a solid-state diode laser, sourced from the device co-developing partner, Iredex Corporation.Mirvant is currently undergoing discussions for potential licensing agreements with leading ophthalmology companies for rostaporfin.In June 2002, Miravant and Bausch & Lomb signed a non-binding letter on intent. The companies are expected to jointly review phase III clinical data concerning rostaporfin. Following the review Bausch & Lomb may negotiate an exclusive worldwide license to develop and commercialise the agent for ophthalmological indications. Previously, in June 1995, Miravant granted Pharmacia & Upjohn (now Pfizer) an exclusive worldwide license for development and marketing of rostaporfin. However, this agreement was terminated in March 2002, at which time Miravant regained the rights to all assets related to rostaporfin. In April 2000, Monsanto merged with Pharmacia & Upjohn to form Pharmacia Corporation. Subsequently, on 16 April 2003, Pharmacia Corporation was acquired by, and merged into, Pfizer.Preclinical studies had been underway for other vision-threatening eye diseases, as it also has potential in the treatment of diabetic retinopathy and glaucoma. The US FDA had granted fast-track status to rostaporfin for the treatment of age-related macular degeneration in 1998.

ISSN:1174-5886    

出版商:ADIS    

年代:2004

数据来源: ADIS