|Clinical Results for ImmunoGen's IMGN901; Array Provides Updates On Clinical Data At Hematology Meeting|
|By Staff and Wire Reports|
|Monday, 10 December 2012 19:35|
ImmunoGen, Inc. (NASDAQ: IMGN), a biotechnology company that develops anticancer therapeutics using its Targeted Antibody Payload (TAP) technology and antibody expertise, announced the presentation of new clinical data with the Company's targeted anticancer compound, IMGN901.
The data were from a Phase I clinical study assessing IMGN901 used in combination with lenalidomide (Revlimid®) and dexamethasone to treat patients with CD56-expressing relapsed or relapsed/refractory multiple myeloma. The data were reported in an oral presentation (abstract #728) at the 54th American Society of Hematology (ASH) Annual Meeting and Exposition in Atlanta, Georgia.
“The level and duration of the responses to the study regimen confirm the activity seen with IMGN901 in earlier trials – where it was evaluated as single-agent therapy – and support the further development of IMGN901 as a treatment for CD56-expressing cancers,” commented James O'Leary, MD, Vice President and Chief Medical Officer.
Array BioPharma (NASDAQ: ARRY) announced positive data for ARRY-520 and ARRY‑614 at the 2012 Annual Meeting of the American Society of Hematology (ASH) in Atlanta, Georgia.
New results presented at the meeting for ARRY-520 in addition to those described in the abstracts published by ASH in early November included:
Overall survival of 19 months and progression free survival of 3.7 months were observed in multiple myeloma patients taking ARRY-520 alone A clinical benefit rate (≥MR) of 50% was observed in heavily pre-treated (median 10 prior regimens) multiple myeloma patients taking ARRY-520 plus dexamethasone who were selected for low AAG levels Initial signs of clinical activity were observed in the ongoing ARRY-520+Kyprolis® (carfilzomib) combination trial: 56% clinical benefit rate (≥MR) In a Phase 2 trial with ARRY-520 in patients with triple-refractory multiple myeloma and a median number of 10 prior treatment regimens, ARRY-520 plus low-dose dexamethasone demonstrated a 22% overall response rate (≥ partial response, or PR), with manageable safety. The most common drug-related adverse events include myelosuppression, fatigue and mucosal inflammation. This response rate is comparable to the response rates reported in pomalidomide and Kyprolis studies, which included patients with only half the number of median prior treatment regimens.
As presented at ASH, researchers found that AAG (acute phase protein alpha-1-acidic glycoprotein) may be a biomarker enabling better patient selection for response to ARRY-520. A related abstract assessing the same group of ARRY-520-treated patients observed that, for patients retrospectively selected with a lower AAG level, the overall response rate (≥PR) increased to 33% (from 22%) with a median time on study of 6.2 months. The clinical benefit rate (≥MR) was 50% in the selected population.
"Multiple myeloma remains an incurable disease, with a significant unmet medical need in patients who are relapsed/refractory to IMiDs and proteasome inhibitors," said Jatin J. Shah, M.D., Assistant Professor, Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas, MD Anderson Cancer Center. "ARRY-520 is a first-in class drug in myeloma with a novel mechanism of action that is very well tolerated and importantly shows very encouraging clinical activity in heavily pre-treated patients who have limited therapeutic options. Furthermore, I am excited about the potential identification of a selection marker, which would help us identify which patients have the best chance to benefit from receiving ARRY-520."
Interim data from an ongoing combination trial of ARRY-520 with Kyprolis in patients with relapsed or refractory MM who are refractory or intolerant to Velcade® (bortezomib) were also reported at the conference. The combination has demonstrated early signals of activity, with a 56% clinical benefit rate (≥MR). In addition, it has been well tolerated with limited hematologic toxicity and a manageable side effect profile.
ARRY520 is currently advancing in three clinical trials, including the two trials presented at ASH. Continued positive results in any one of these trials will define a clear path to late stage development:
Phase 2 trial in combination with dexamethasone in patients with MM refractory to Revlimid® (lenalidomide), Velcade and dexamethasone therapy. Phase 1b trial in combination with Velcade plus dexamethasone in patients with relapsed or refractory MM. Phase 1b investigator-sponsored trial in combination with Kyprolis in patients with relapsed or refractory MM who are refractory or intolerant to Velcade therapy. In the Phase 1 trial with ARRY-614, a dual p38/Tie2 inhibitor, the new formulation demonstrated improved bioavailability and inter-patient variability in our ongoing study of low or intermediate-1 risk Myelodysplastic Syndromes (MDS). With this new formulation, peak plasma concentrations and overall exposures are higher than with the original formulation, possibly affording more extensive Tie2 inhibition. The ongoing Phase 1 dose escalation trial of the optimized ARRY-614 formulation may further our understanding of the contributions of these targets to the pathogenesis of MDS. In our prior study in a similar population, we observed a 38% response rate for hematologic improvement in patients receiving the highest dose of the prior formulation. At this dose, ARRY-614 demonstrated multilineage hematologic improvement in 67% of the responders, improving two or more cytopenias (neutropenia, thrombocytopenia and/or anemia). The most common drug related adverse events in this study included diarrhea and skin rash.
Amgen (NASDAQ: AMGN) and deCODE Genetics today announced that the companies have entered into a definitive agreement under which Amgen will acquire deCODE Genetics, a global leader in human genetics, headquartered in Reykjavik, Iceland.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced updated molecular response data from its Phase 1 and pivotal Phase 2 trials of ponatinib, its investigational BCR-ABL inhibitor, in heavily pretreated patients with resistant or intolerant chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
Array BioPharma Inc. (NASDAQ: ARRY) today announced positive data for ARRY-520 and ARRY‑614 at the 2012 Annual Meeting of the American Society of Hematology (ASH) in Atlanta, Georgia.
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Organovo Holdings, Inc. (OTCQX: ONVO) the San Diego-based regenerative medicine company focused on using its breakthrough NovoGen 3D human tissue printing technology to create tissue on demand for medical research and therapeutic applications, today announced that Keith Murphy, CEO, will present at RetailInvestorConferences.com.
RetailInvestorConferences.com is pleased to announce that BioSpecifics Technologies Corp.'s (NASDAQ: BSTC) December 6th RetailInvestorConferences.com presentation is now available for on-demand viewing. BioSpecifics is a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® in the U.S. and XIAPEX® in Europe and Eurasia.
Sunshine Biopharma Inc. (OTCQB: SBFM), a pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer, today announced that it has completed a new IND-Enabling study in which Adva-27a, the Company's flagship oncology drug candidate, was found to be effective at killing Multidrug Resistant Uterine Cancer Cells in vitro.
Synergetics USA, Inc. (NASDAQ: SURG), a medical device company that designs, manufactures, and markets innovative surgical devices for ophthalmic and neurosurgical applications, today reported growth in sales, gross profit, operating margin, income from continuing operations and net income for the first quarter ended October 31, 2012.