Articles tagged with: Clinical Trial Results

Press Releases»

[ by | Aug 4, 2014 7:30 am | Comments Off ]

Kyprolis Helped Patients Live 8.7 Months Longer Without Their Disease Worsening
Results to Form Basis of Regulatory Filings Beginning in 1H 2015

Amgen Announces Phase 3 ASPIRE Trial Of Kyprolis In Patients With Relapsed Multiple Myeloma Met Primary Endpoint Thousand Oaks, California and South San Francisco, California (Press Release) Amgen (NASDAQ:AMGN) and its sub­sid­i­ary, Onyx Pharma­ceu­ticals, Inc., today announced that a planned interim analysis demon­strated that the Phase 3 clin­i­cal trial ASPIRE (CArfilzomib, Lena­lido­mide, and DexamethaSone versus Lena­lido­mide and Dexamethasone for the treat­ment of PatIents with Relapsed Multiple MyEloma) met its pri­mary end­point of pro­gres­sion-free survival (PFS). Patients treated with Kyprolis® (car­filz­o­mib) for Injection in com­bi­na­tion with Revlimid® (lena­lido­mide) and low-dose dexa­meth­a­sone (KRd) lived sig­nif­i­cantly longer without their disease worsening (median 26.3 months) compared …

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[ by | Jun 2, 2014 9:00 am | Comments Off ]
  • Results show adding LBH589 to bortezomib and dexamethasone significantly improved PFS by 37%, meeting Phase III study primary endpoint[1]
  • Median PFS increased by 4 months (12 months in LBH589 arm versus 8 months in placebo arm); effect of LBH589 observed across all patient subgroups[1]
  • Most people with multiple myeloma will relapse or become refractory; if approved, LBH589 will be first in its class of anticancer agents available to this population[1]
  • Based on these data, US

 …

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[ by | Mar 26, 2014 11:00 pm | Comments Off ]

- 4/12 patients (33%) showed evi­dence of stable disease; 2 patients for more than 130 days
- A clin­i­cally-relevant mean time to next ther­apy of 51 days
- PAT-SM6 specifically targets myeloma tumour cells in vivo and stimulates signifcant immune responses
- All dose levels admin­istered were safe with no adverse events observed
- No evi­dence of immunogenicity; PK analysis showed PAT-SM6 to have a half-life of 7 hrs

Melbourne, Australia (Press Release) - Patrys Limited (ASX: PAB; “the Company”), a clin­i­cal stage bio­tech­nology com­pany, is pleased to announce the final results from …

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[ by | Dec 9, 2013 4:00 pm | Comments Off ]

− Oral Data Presentation to be Featured in “Highlights of ASH” −

Updated Data With Oral Proteasome Inhibitor MLN9708 Reported In Newly Diagnosed Multiple Myeloma Patients New Orleans, LA & Osaka, Japan (Press Release) - Takeda Pharma­ceu­tical Company Limited (TSE:4502) today announced final Phase 1 and pre­lim­i­nary Phase 2 results of a study combining oral inves­ti­ga­tional MLN9708 admin­istered twice a week with lena­lido­mide and dexa­meth­a­sone in patients with newly diag­nosed multiple myeloma (MM). The investigators reported a com­bined com­plete response and very good partial response (CR+VGPR) rate of 76 per­cent (46/62) and a 94 per­cent over­all response rate (ORR; 58/62 ≥ partial response). Stringent com­plete response (sCR) was reached in 75 per­cent of patients …

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[ by | Dec 9, 2013 7:15 am | Comments Off ]

- Additional Preclinical Data Presented on Ricolinostat in Potential New Drug Combinations and HDAC6 Biomarkers in Multiple Myeloma -

Boston, MA (Press Release) - Acetylon Pharma­ceu­ticals, Inc., the leader in the devel­op­ment of selective histone deacetylase (HDAC) inhibitors for en­hanced thera­peutic out­comes, today announced that positive interim clin­i­cal data from the two proof-of-concept clin­i­cal trials with selective HDAC6 inhibitor, ricolinostat (ACY-1215), were presented at the 55th Annual Meeting of the American Society of Hematology (ASH) in New Orleans, LA. The two trials are the Phase 1b dose escalation portion of …

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[ by | Dec 6, 2013 1:15 am | Comments Off ]

- Study of LBH589 plus bor­tez­o­mib and dexa­meth­a­sone met pri­mary end­point of extending PFS compared to bor­tez­o­mib plus dexa­meth­a­sone and placebo
- LBH589 has poten­tial to be the first in its class of anticancer agents avail­able to patients with multiple myeloma
- Data will be presented at an upcoming medical congress and discussed with regu­la­tory author­i­ties world­wide

Basel, Switzerland (Press Release) - Novartis today announced that results of a Phase III trial of the in­ves­ti­ga­tional com­­pound LBH589 (panobinostat) in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone, met the pri­mary end­point of sig­nif­i­cantly extending pro­gres­sion-free …

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[ by | Sep 5, 2013 7:30 am | Comments Off ]

Poma­lido­mide plus low-dose dexa­metha­sone dem­onstrated sig­nif­i­cantly longer median pro­gres­sion-free survival and over­all survival at a median follow-up of 10 months

Results From Phase III Study (MM-003) Of Poma­lido­mide Plus Low-Dose Dexa­metha­sone Versus High-Dose Dexa­metha­sone In Relapsed And Refractory Multiple Myeloma Patients Published In The Lancet Oncology Boudry, Switzerland (Press Release) - Celgene Inter­na­tional Sàrl, a wholly-owned sub­sid­i­ary of Celgene Corpo­ra­tion (NASDAQ:CELG), today announced that updated results from MM-003, a phase III multi-center, ran­dom­ized open-label study (n=455) of poma­lido­mide (marketed as POMALYST® in the U.S. and IMNOVID® in the E.U.) plus low-dose dexa­metha­sone, were published online ahead of print in The Lancet Oncology.

The study compared oral poma­lido­mide plus low-dose dexa­metha­sone with high-dose dexa­metha­sone in patients with refractory or re­lapsed and refractory multiple myeloma who have failed at least two prior thera­pies with both bor­tez­o­mib and lena­lido­mide, ad­min­is­tered alone or in …

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