Positive Results of Clinical Trials on TRACON; Axovant's RVT-101 Phase 2b Completer Analysis Demonstrates Statistically Significance Print E-mail
By William Kent   
Wednesday, 22 July 2015 17:54
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 22, 2015.
ACI Association has initiated research coverage on TRACON Pharmaceuticals, Inc. (NASDAQ: TCON). Select highlights from the internally released reports are being made available to the general public (included below), with access to the entirety of the research available to new members.
Highlights from our TCON Report include:  Clinical Trial Results - On June 1, 2015, TRACON Pharmaceuticals reported positive results from two separate clinical trials combining TRC105 with approved VEGF inhibitors. The trial showed that complete responses were observed in two patients with angiosarcoma in TRC105 combined with Votrient sarcoma study. Data from the trials were presented at the American Society of Clinical Oncology (ASCO) 2015 Annual Meeting in Chicago.
TRC105 in Combination with Votrient - The first study of the trial was the dose escalation Phase 1b portion of a Phase 1b/2 study of TRC105 in combination with Votrient® (pazopanib) in 18 patients with advanced soft tissue sarcomas. Minimum one prior chemotherapy regimen was received, and prior treatment with Votrient was allowed to all patients in the Phase 1b study. In the Phase 1b study, on an average, patients had received two prior therapies which ranged from one to seven. All patients were treated with the combination of TRC105 given once weekly (8 or 10 mg/kg) and Votrient at its approved dose of 800 mg per day.
TRC105 in Combination with Nexavar - Updated data was presented for the dose escalation Phase 1b portion of a Phase 1b/2 study of TRC105 in combination with Nexavar® (sorafenib) in 20 patients with liver cancer, by the National Cancer Institute (NCI). Patients had compensated liver dysfunction and had not received prior treatment with Nexavar. All 20 patients enrolled in the clinical trial were treated with the combination of TRC105 given once every two weeks (3, 6, 10 or 15 mg/kg) and Nexavar at its approved dose of 400 mg given twice daily.
Views of Management - Commenting on the clinical trial, Charles Theuer, M.D., Ph.D, President and CEO of TRACON said, "We continue to see encouraging data for TRC105 in combination with VEGF inhibitors that support targeting the endoglin and VEGF pathways simultaneously to deliver improved patient outcomes."
Axovant Sciences Ltd. (NYSE: AXON), a leading clinical-stage biopharmaceutical company focused on the treatment of dementia, announces new results from a 684-subject phase 2b clinical trial evaluating Axovant's lead product candidate, RVT-101, as an adjunctive therapy to donepezil in patients with mild-to-moderate Alzheimer's disease.
In Axovant's analysis of all patients with complete data at each study visit, patients receiving 35 mg RVT-101 in combination with donepezil demonstrated statistically significant improvements in cognition and function at 12, 24, 36, and 48 weeks as compared to patients receiving donepezil alone. Cognition was measured by the Alzheimer's Disease Assessment Scale – cognitive subscale (ADAS-cog) and function was measured by the Alzheimer's Disease Cooperative Study – Activities of Daily Living scale (ADCS-ADL). ADAS-cog and ADCS-ADL have each been used as endpoints to obtain regulatory approval of currently-marketed Alzheimer's disease treatments.
Axovant's completer analysis reinforces the protocol-specified analysis of the intent-to-treat (ITT) population from this same study, published in Alzheimer's & Dementia, where patients receiving 35 mg RVT-101 plus donepezil also demonstrated statistically significant improvements on the ADAS-cog and ADCS-ADL compared to patients receiving donepezil alone. These results also suggested a consistent dose response across placebo, 15mg RVT-101, and 35mg RVT-101, the only doses that were tested.
"These phase 2b results demonstrate that RVT-101 has the potential to be a significant advance in the treatment of mild-to-moderate Alzheimer's disease," said Dr. Lawrence Friedhoff, Chief Development Officer of Axovant Sciences, Inc., who formerly led the development of Aricept (donepezil) for Alzheimer's disease. "Statistically significant improvements were seen consistently across multiple analyses on the ADAS-cog and ADCS-ADL, endpoints historically used by the FDA and EMA to approve new Alzheimer's drugs."
RVT-101 was well-tolerated by subjects in all 13 clinical trials conducted to date.  "Based on the phase 2b data, I believe RVT-101 has the potential to safely improve cognition and function in Alzheimer's disease patients who are in need of new therapeutic options," said Dr. Atul Pande, who previously oversaw the development of RVT-101 at GlaxoSmithKline as SVP, Neurosciences and currently serves on Axovant's Board of Directors. "The data to date warrant advancement of RVT-101 into the upcoming confirmatory phase 3 study. I am especially encouraged to see the experienced development team at Axovant advance this program under the leadership of Dr. Friedhoff."
Also Wednesday:
AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG) announced today that it has entered into an agreement that grants AMAG an exclusive option to acquire the rights to an orphan drug candidate at the conclusion of a Phase 2b/3a clinical trial. Digoxin immune fab (DIF) is a polyclonal antibody being developed for the treatment of severe preeclampsia in pregnant women.
Amarantus Diagnostics, a neurology-focused diagnostics company developing diagnostic tests for multiple sclerosis and Alzheimer's disease and a wholly-owned subsidiary of Amarantus Bioscience Holdings, Inc. (OTCQX:AMBS), today reported positive results on the accuracy of the LymPro Test®, its blood-based diagnostic assay for Alzheimer's disease (AD), to discriminate between subjects with clinically diagnosed AD versus healthy controls at the Alzheimer's Association International Conference® (AAIC) being held July 18-23, 2015, in Washington, DC.
Anavex Life Sciences Corp. (OTCQX:AVXL) today announced initial positive cognitive data for ANAVEX 2-73, the Company’s lead investigational oral treatment for Alzheimer’s targeting sigma-1 and muscarinic receptors, which is believed to reduce protein misfolding including reduction of beta amyloid, tau and inflammation.  
Capnia, Inc. (NASDAQ:CAPN), focused on the development and commercialization of novel products based on its proprietary technologies for precision metering of gas flow, today announced enrollment of the first patient in an investigator-sponsored clinical trial evaluating Capnia's proprietary nasal, non-inhaled carbon dioxide (nasal CO2) technology for the treatment of cluster headaches.
Diversicare Healthcare Services, Inc. (NASDAQ:DVCR) today announced that it is scheduled to report financial results for its second quarter ended June 30, 2015, on Thursday, August 6, 2015, after the market closes. Diversicare will also hold a conference call at 8:30 a.m. ET, 7:30 a.m. CT, on Friday, August 7, 2015.
Fibrocell Science, Inc., (NASDAQ:FCSC), an autologous cell and gene therapy company focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet needs, today announced the pricing of an underwritten public offering of 2.6 million shares of its common stock at a price of $5.80 per share.
Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that, following communication with the FDA, it is proceeding with Phase 3 development of ITI-007 for the treatment of depressive episodes associated with bipolar disorder (bipolar depression).
LHC Group, Inc. (NASDAQ:LHCG), a national provider of home health, hospice and comprehensive post-acute healthcare services, announced today details for the release of its results for the second quarter and six months ended June 30, 2015.
Macrocure Ltd. (NASDAQ:MCUR), a clinical-stage biotechnology company focused on developing a novel therapeutic platform to address chronic and hard-to-heal wounds, will announce financial results for the second quarter ended June 30, 2015 after the close of the U.S. financial markets on Tuesday, August 4, 2015.
National Research Corporation (NASDAQ:NRCIA) (NASDAQ:NRCIB) today announced that it will provide an online Web simulcast of its 2015 second quarter conference call on Wednesday, August 5, 2015.
Natus Medical Incorporated (NASDAQ:BABY) today announced financial results for the three months ended June 30, 2015.
NewLink Genetics Corporation (Nasdaq:NLNK), a biopharmaceutical company at the forefront of developing novel immuno-oncology and infectious-disease products to improve the lives of patients, today announced that Dr. Thomas Monath has received the James H. Steele Gold-Headed Cane Award of the American Veterinary Epidemiology Society (AVES). 
Proteon Therapeutics Inc. (Nasdaq:PRTO), a company developing novel, first-in-class therapeutics to address the medical needs of patients with kidney and vascular diseases, today announced the appointment of Scott Canute to its Board of Directors.
StemCells, Inc. (Nasdaq:STEM), a leading stem cell company developing and commercializing novel cell-based therapeutics and tools for use in stem cell-based research and drug discovery, announced today that it will release financial results for the second quarter 2015, after the market close on Thursday, August 6. 
Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP), a global biopharmaceutical company, today announced that it will host its second quarter 2015 financial results teleconference and webcast at 8:30 a.m. Eastern on Wednesday, August 5, 2015.
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced the Phase 3 EYEGUARD-B study of gevokizumab in patients with Behçet's disease uveitis, run by its partner Servier, an independent French pharmaceutical research company driven by the pursuit of innovative drugs, did not meet the primary endpoint of time to first acute ocular exacerbation.

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