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pharmafile | January 24, 2008 | News story | Research and Development |Â Â Â
Access licenses MuGard to Rhei Pharmaceuticals
Access Pharmaceuticals and Rhei Pharmaceuticals have signed a definitive licensing agreement under which Rhei will market Access's proprietary product MuGard in the Peoples Republic of China and certain other Southeast Asian countries. MuGard has received marketing allowance from the FDA for the management of oral mucositis.
Rhei Pharmaceuticals will be responsible for marketing MuGard in China, Hong Kong, Macau, Taiwan, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam, as well as for manufacturing and for obtaining the necessary regulatory approvals for the product in the territory.
Sylvia He, CEO of Rhei, said: "We are pleased to have MuGard in our portfolio of products in China, building on our expertise in the area of oncology. Our mission is to bring innovative products to the Chinese market and MuGard fulfills a real medical need. With an increasing number of patients receiving radiation and chemotherapy in China, the prevalence of oral mucositis is growing. Our expert capabilities in sales and marketing, manufacturing and regulatory will help to maximize MuGard's potential in the marketplace."
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Agennix receives FDA nod for Phase III lung cancer trial
Agennix has reported that the FDA has approved the design of a single, pivotal, Phase III trial evaluating its lead molecule, talactoferrin alfa, in combination with chemotherapy as first-line treatment in patients with non-small cell lung cancer under the special protocol assessment process.
The Phase III, multinational, randomized, double-blind, placebo-controlled study will enroll 1,100 previously untreated patients with Stage IIIB or IV non-small cell lung cancer (NSCLC). The patients will be randomly assigned to receive up to six cycles of standard chemotherapy (carboplatin and paclitaxel) plus either oral talactoferrin or placebo. Following six cycles of chemotherapy, or discontinuation prior to six cycles for reasons other than progression, patients will receive talactoferrin or placebo as maintenance therapy until disease progression. Progression-free survival and overall survival will be the primary endpoints for accelerated approval and regular approval, respectively. Secondary endpoints include adverse event reductions, confirmed response rate, duration of response and safety.
Agennix also received scientific advice from the European Medicines Agency (EMEA) indicating that this single trial will also support a marketing authorization application in the EU.
Waun Ki Hong, member of Scientific Advisory Board at Agennix, said: "Talactoferrin has the potential to be an important advance in the treatment of NSCLC. I look forward to confirmation of the Phase II results in the Phase III trials."
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Cell Therapeutics reports positive results of Phase II lymphoma trial
Cell Therapeutics has announced positive results of a Phase II clinical study, which demonstrated that the addition of radioimmunotherapy to high-dose chemotherapy followed by autologous stem-cell transplantation produced a high rate of progression-free survival at two years without a significant increase in the toxicity of the HDC regimen underscoring the potential role for RIT in ASCT.
The trial evaluated the safety and efficacy of combining a standard dose of Zevalin followed by high-dose Beam and autologous stem-cell transplantation (ASCT) in patients with non-Hodgkin's lymphoma who were considered ineligible for total-body irradiation because of older age or prior radiotherapy. Primary endpoints of the study were overall and progression-free survival. Secondary endpoints included safety and long-term complications.
The study, conducted at the City of Hope Comprehensive Cancer Center, used a single dose of Zevalin in patients undergoing ASCT following high-dose chemotherapy (HDC) with the Beam regimen (carmustine, cytarabine, etoposide, and melphalan). Thirty-seven of the 41 patients had failed prior rituximab therapy. Seven of the ten patients transplanted in partial remission (70%) converted to complete remissions following the Zevalin-based regimen. The addition of Zevalin to the Beam regimen did not appear to add to the toxicity of HDC; the day 100 mortality rate was zero percent. Importantly the two-year overall and progression-free survival estimates were approximately 89% and 70%.
Jack Singer, chief medical officer at Cell Therapeutics, said: "The promise of utilizing targeted radioimmunotherapy together with high-dose chemotherapy prior to autologous stem-cell transplant is an exciting new potential application of Zevalin. We expect to explore this as an additional registration direction for Zevalin."
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Epix announces revised results of Phase IIa Alzheimer's trial
Epix Pharmaceuticals has reported revised results from a Phase IIa clinical trial of PRX-03140, its novel 5-HT4 agonist in Alzheimer's disease.
The trial was designed to assess the effects of PRX-03140 following two weeks of treatment as monotherapy and separately in combination with donepezil in patients with mild Alzheimer's disease and the company announced initial findings on December 18, 2007.
As a result of errors made in the transcription of data and calculation of the Alzheimer's disease assessment scale cognitive subscale (ADAS-cog) score, an independent re-analysis of the data has been conducted. The corrected results show that patients receiving 150mg of PRX-03140 orally once daily as monotherapy achieved a mean 3.6 point improvement on the ADAS-cog versus a 0.9 point worsening in patients on placebo, which continues to be statistically significant (p= 0.021). Data for the patients on a 50mg dose of PRX-03140 showed a one point improvement on the ADAS-cog. The monotherapy dose response (150mg versus 50mg versus placebo) continues to be statistically significant with p=0.026. There were no substantive changes in the results from the combination arms of the study.
In the Phase IIa clinical trial, PRX-03140 appeared to be well tolerated, both alone and in combination with donepezil (Aricept). No serious drug-related adverse events occurred during the trial. The two-week study also utilized other cognitive tests including Mindstreams, an automated battery of computerized cognitive function tests. Patients on monotherapy demonstrated significant (p<0.04) improvements in memory and visual-spatial indices as measured using Mindstreams when compared with placebo.
Michael Kauffman, CEO of Epix, said: "With our partner, GlaxoSmithKline, we are continuing with our plans to initiate a Phase IIb clinical trial program in Alzheimer's patients in the first half of 2008."
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Galapagos receives E4.4 million for arthritis drug development
Galapagos has been awarded an E4.4 million grant from the Flanders government through the Institute for the Promotion of Innovation by Science and Technology. The three-year project aims to accelerate Galapagos's rheumatoid arthritis programs through clinical proof of concept in man.
This project builds on the progress of Galapagos's July 2006 IWT funded project, where new biological models were developed to evaluate the effectiveness of small molecules to treat rheumatoid arthritis (RA). The new project will apply these biological models to select compounds for clinical studies.
The project also aims to develop and validate biomarkers to monitor disease progression and therapeutic response, which will be applied in the early phases of clinical development. The grant, which will be distributed over a three-year period, will offset preclinical and Phase I/Phase IIa clinical costs for Galapagos's RA programs. As part of the project, Galapagos will collaborate with the University of Leuven.
Onno van de Stolpe, CEO of Galapagos, said: "This grant allows us to accelerate our molecules through preclinical and into Phase I and Phase IIa development, bringing Galapagos a step closer to delivering novel and effective RA drugs to the patient."
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