MiMedx Group, a major supplier to government-run hospitals, has said its products help heal wounded service members and veterans, however the company limited the range of products it offered to federal buyers forcing the government to purchase more costly products than it needed for common treatments, the Wall Street Journal reports, citing former employees and company product lists. The company, which manufactures skin grafts and injectable products from placental tissues, has faced headwinds this year including restating financial results since 2012, ousting founder and former CEO Parker Petit and facing investigations into its practices by the Justice Department, the Department of Veterans Affairs and the Securities and Exchange Commission.
Friday, October 5, 2018
Calithera Biosciences announces trials to evaluate Pfizer’s Ibrance with CB-839
Calithera Biosciences (CALA) announced two new clinical trial collaborations to evaluate Pfizer’s (PFE) palbociclib, also known as Ibrance, and the investigational dual-mechanism poly, or ADP-ribose, polymerase, or PARP, inhibitor talazoparib, each in combination with Calithera’s glutaminase inhibitor CB-839. As part of the collaboration, Pfizer will provide palbociclib and talazoparib, as well as financial support. Preclinical data suggest that CB-839, which is designed to starve tumor cells of the key nutrient glutamine, synergizes with CDK4/6 inhibitors by enhancing cell cycle arrest and blocking cancer cell proliferation. The combination of CB-839 with CDK4/6 inhibitors has demonstrated synergistic activity in a number of preclinical cancer models, including colorectal cancer, or CRC, non-small cell lung carcinoma, or NSCLC, triple negative breast cancer, or TNBC and ER+ breast cancer. Based on these data, Calithera will initiate a Phase 1/2 clinical trial of the combination of CB-839 plus palbociclib in patients with KRAS mutated CRC and patients with KRAS mutated NSCLC in Q1 of 2019. CB-839 also synergizes with PARP inhibitors to impair DNA synthesis, enhance DNA damage, and block cancer cell proliferation. The combination of CB-839 with PARP inhibitors has demonstrated synergistic activity in a number of preclinical cancer models, including renal cell carcinoma, TNBC, CRC, NSCLC, ovarian cancer and prostate cancer. Based on these data, Calithera will initiate a Phase 1/2 clinical trial of the combination of CB-839 plus talazoparib in patients with RCC, and TNBC in Q1 of 2019.
PetIQ price target raised to $50 from $28 at Oppenheimer
Oppenheimer analyst Brian Nagel reiterated an Outperform rating on PetIQ and raised his price target to $50 from $28. In a research note to investors, Nagel says PetIQ’s “unique” business model continues to take shape well and the market is still meaningfully under-appreciating the company’s longer-term sales and profit potential. He also contends that the acquisition of VIP Petcare not only affords the chain a new, higher margin revenue stream, but also serves to meaningfully strengthen its core distribution business.
Amicus announces additional results from ATB200-02 study
Amicus announced additional results from a global Phase 1/2 clinical study, or ATB200-02, to investigate AT-GAA in patients with Pompe disease, an inherited lysosomal storage disorder caused by an enzyme deficiency that leads to accumulation of glycogen in cells. Patients treated with AT-GAA for up to 18 months showed improvements in six-minute walk test, or 6MWT, distance and other measures of motor function and muscle strength, stability or increases in forced vital capacity, or FVC, and durable reductions in biomarkers of muscle damage and disease substrate. These clinical results are being featured at the International Annual Congress of the World Muscle Society. Safety and tolerability data in all 20 patients reflect a maximum of 28+ months of treatment. To date, adverse events have been generally mild and transient. Data on functional outcomes are available for 19 of the 20 patients enrolled. Muscle function improved in 17 of 19 patients at month 12. Muscle function improved in 17 out of 18 patients with available data at month 18. Six-minute walk test distance, a primary measure of motor function in Pompe disease patients, improved in both ERT-naive and ERT-switch patients with continued benefit observed out to month 18. Improvements were generally consistent across both cohorts. three of the four non-ambulatory ERT-switch patients showed improvements in upper extremity strength from baseline to month 18, as measured by quantitative muscle testing and manual muscle testing. Pulmonary function improved in ERT-naive patients and was generally stable in ERT-switch patients. Treatment with AT-GAA resulted in persistent and durable reductions in key biomarkers of muscle damage and disease substrate across all patient cohorts out to month 18 and continue to suggest a positive effect on muscle tissue.
Allergan launches two global clinical research programs for brazikumab
Allergan announced the initiation of two global clinical research programs for brazikumab, an investigational drug being studied for inflammatory bowel disease. INTREPID (Crohn’s disease) and EXPEDITION (ulcerative colitis), will evaluate the safety and efficacy of brazikumab and will investigate the role of biomarkers in determining a predictive response of brazikumab in patients with IBD. They are the first active comparator studies of an IL-23 inhibitor therapy in IBD to evaluate biomarkers as potential predictors of treatment response and the first randomized comparison of an IL-23 inhibitor versus HUMIRA (adalimumab) in Crohn’s disease and ENTYVIO (vedolizumab) in ulcerative colitis. Allergan is initiating the INTREPID and EXPEDITION programs following a Phase 2 clinical trial that showed higher anti-inflammatory response and remission rates with brazikumab in patients with Crohn’s disease who had higher levels of a key IBD biomarker compared to those who had lower levels.
Adamas Pharmaceuticals downgraded on Gocovri ramp at BofA/Merrill
BofA/Merrill downgraded Adamas Pharmaceuticals to Neutral from Buy and cut its price target to $25 from $38. Analyst Tazeen Ahmad’s checks with physicians indicate Gocovri dropouts are occurring, doctors may be looking at other options, and Gocovri’s value proposition is not fully appreciated. Ahmad believes Gocovri is differentiated by its time release biology, but said the level of doctors excitement is still in the middle range and is taking longer than previous expectations to become a “go-to drug.” The analyst also said the launch of Osmotica Pharmaceuticals’ Osmolex ER could impact pick-up and lowered Gocovri’s peak sales estimate to $428M from $553M.
Cytokinetics, Astellas: COPD trial did not meet primary endpoint
Cytokinetics (CYTK) and Astellas Pharma (ALPMY) provided an update for their collaborative skeletal muscle program, including clinical trial updates for reldesemtiv in neuromuscular and non-neuromuscular conditions. Astellas recently completed a Phase 2 clinical trial designed to assess the potential effect of reldesemtiv compared to placebo on exercise tolerance, assessed as change from baseline in Constant Work Rate endurance time over two weeks, in approximately 40 patients with Chronic Obstructive Pulmonary Disease, or COPD. Additionally, the trial assessed other cardiopulmonary and neuromuscular effects and resting spirometry. In addition, the safety, tolerability and pharmacokinetics of reldesemtiv were assessed. This trial of reldesemtiv did not meet the primary endpoint and did not demonstrate a statistically significant treatment difference in any of the secondary endpoints. Adverse events were similar between groups receiving reldesemtiv and placebo. Astellas has been conducting a Phase 1b clinical trial designed to assess the effect of reldesemtiv versus placebo on skeletal muscle fatigue in approximately 60 subjects who are 70 to 89 years of age and who have limited mobility. Endpoints measured include the change from baseline versus 14 days of treatment in sum of peak torque during isokinetic knee extensions. Additionally, the trial is designed to assess the effects of reldesemtiv on physical performance as well as the safety, tolerability and pharmacokinetics of reldesemtiv. An interim analysis of this study was recently conducted, and the Independent Data Monitoring Committee determined that the pre-defined criteria for lack of efficacy of reldesemtiv had been met; Astellas has notified investigators to halt further enrollment in the trial. As recently announced, Cytokinetics and Astellas are advancing a next-generation FSTA into IND-enabling studies, which triggers a $2M milestone payment from Astellas to Cytokinetics. This potential drug candidate was designed to have different physicochemical properties than reldesemtiv and may be developed for the treatment of diseases and conditions associated with non-neuromuscular etiology and pathogenesis. The companies are also continuing their joint research program with Astellas providing sponsorship of Cytokinetics’ activities through 2019.
https://thefly.com/landingPageNews.php?id=2800363
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