‘Study’ Tagged Posts

Biogen and Eisai current detailed outcomes from section 1b examine of aducanumab at CTAD assembly

Biogen and Eisai Co., Ltd. introduced that Biogen introduced outcomes on the Medical Trials on Alzheimer's Illness (CTAD) assembly, in Barcelona, Sp...


Biogen and Eisai Co., Ltd. introduced that Biogen introduced outcomes on the Medical Trials on Alzheimer’s Illness (CTAD) assembly, in Barcelona, Spain, from the current 36- and 48-month analyses of the continuing long-term extension (LTE) of the Section 1b examine of aducanumab, an investigational therapy for gentle cognitive impairment (MCI) as a consequence of Alzheimer’s illness (AD) and gentle AD.

A late-breaking oral presentation and a poster included knowledge from sufferers handled with aducanumab for as much as 36 and 48 months. Knowledge from each analyses confirmed a discount in amyloid plaque ranges in a dose- and time-dependent method, as measured by positron emission tomography (PET). As well as, analyses of exploratory medical endpoints, Medical Dementia Score Sum of Containers (CDR-SB) and the Mini-Psychological State Examination (MMSE), prompt a continued slowing of medical decline over 36 months and 48 months. The leads to every dosing arm had been usually according to beforehand reported analyses of this examine, and there have been no modifications to the risk-benefit profile of aducanumab.

“This Section 1b examine now has 4 years of aducanumab outcomes, and we’re inspired by these knowledge, which continued to indicate a discount in amyloid plaque ranges and counsel our investigational remedy might gradual medical development of the illness,” stated Alfred Sandrock, Jr., M.D., Ph.D., govt vp and chief medical officer at Biogen. “The Section three research are actually absolutely enrolled, and we stay pushed by the profound unmet wants of sufferers, households, caregivers and society.”​



AEGEA Medical begins PACE II medical research in ladies who underwent endometrial ablation


AEGEA Medical, Inc. has introduced the graduation of the Submit-Ablation Cavity Entry (PACE II) medical research in ladies who beforehand underwent endometrial ablation as a part of AEGEA’s pivotal trial of the corporate’s patented Adaptive Vapor Ablation expertise. The multi-center observational research, which is being carried out at seven websites throughout the U.S. in as much as 50 ladies, is designed to evaluate uterine cavity entry in addition to the feasibility of diagnostic and therapeutic interventions three to 4 years following remedy.

AEGEA Medical is conducting the PACE II research primarily based on outcomes from the AEGEA PACE pilot research, which discovered that post-procedure entry to the mid-uterine cavity or past was attainable in 82 % of the research’s 11 sufferers who beforehand participated in a Part II research of vapor ablation in The Netherlands. The first observational endpoint of PACE II is the power to entry the uterine cavity and carry out a diagnostic hysteroscopic examination, with different observational endpoints together with feasibility of endometrial biopsy and IUD placement, the power to visualise the uterine cornua/ostia, and presence and traits of adhesions throughout the uterine cavity. The corporate expects PACE II to be accomplished inside six months.

“Whereas endometrial ablation applied sciences have served physicians and their sufferers effectively for a while, the difficulty of post-procedure uterine cavity entry has by no means actually been addressed,” mentioned Maria Sainz, president and CEO of AEGEA Medical. “We consider it is a crucial success metric for the remedy, because it speaks to the opportunity of future uterine-related interventions. The PACE Pilot knowledge on 11 sufferers handled with Adaptive Vapor Ablation expertise could be very promising in how Vapor Ablation can tackle this unmet want, preserving doctor and affected person choices sooner or later.”

Endometrial ablation is a secure, efficient and fast-growing process for the remedy of heavy menstrual bleeding (menorrhagia), with the variety of U.S. circumstances estimated to have elevated from 430,000 in 2014 to 490,000 in 2017 alone. Because the variety of procedures continues to rise per yr, research have proven that scar tissue and re-access to the cavity could be difficult publish remedy, limiting the power to seek for suspected most cancers by way of ultrasound or biopsy, and ruling out the usage of IUDs for therapeutic intervention. In these situations, the dearth of post-procedure uterine cavity entry typically leaves ladies with hysterectomy as the one viable possibility.

“Submit-procedure uterine cavity entry is the following massive subject in endometrial ablation,” mentioned the research’s Nationwide Principal Investigator, Alan Johns, MD, Medical Director, Medical Analysis Baylor Analysis Institute, Fort Value. “Given the early efficiency of AEGEA’s Adaptive Vapor Ablation expertise on this space, I consider it has the potential to deal with this concern, offering physicians and sufferers with a extra considerate method to endometrial ablation that permits for future uterine interventions as needed. Importantly, this multi-center research has been designed with goal standards to keep away from affected person choice bias. Moreover, the research consists of unbiased knowledgeable evaluation of the hysteroscopy imagery to additional improve the information’s scientific rigor.”


Section III CLL14 examine evaluating Venclexta plus Gazyva to deal with CLL meets its major endpoint


Genentech, a member of the Roche Group , introduced as we speak that the randomized Section III CLL14 examine, which evaluated fixed-duration Venclexta® (venetoclax) together with Gazyva® (obinutuzumab) in folks with beforehand untreated power lymphocytic leukemia (CLL) and co-existing medical circumstances, met its major endpoint and confirmed a statistically vital discount within the danger of illness worsening or dying (progression-free survival [PFS] as assessed by investigator) in comparison with standard-of-care Gazyva plus chlorambucil. The outcomes confirmed that no new security alerts or enhance in identified toxicities of Venclexta or Gazyva have been noticed with the remedy mixture.

“Individuals with power lymphocytic leukemia proceed to want extra remedy choices as a result of some sufferers are unable to tolerate chemotherapy regimens as a result of their underlying well being,” mentioned Sandra Horning, M.D., chief medical officer and head of International Product Growth. “CLL14 is the primary examine to point out superior progression-free survival for Venclexta plus Gazyva in comparison with a standard-of-care routine. We are going to work with well being authorities to deliver this potential chemotherapy-free remedy choice to individuals who want it as shortly as doable.”

Knowledge from the CLL14 examine shall be submitted to world well being authorities. Venclexta together with Rituxan® (rituximab) has been permitted by the U.S. Meals and Drug Administration (FDA) for the remedy of individuals with CLL or small lymphocytic lymphoma, with or with out 17p deletion, who’ve obtained at the very least one prior remedy. A supplemental New Drug Software (sNDA) is at the moment underneath assessment by the FDA for Venclexta together with a hypomethylating agent or together with low dose cytarabine for the remedy of individuals with beforehand untreated acute myeloid leukemia (AML) who’re ineligible for intensive chemotherapy, with a call anticipated by finish of 12 months.

A strong medical growth program for Venclexta is ongoing in a number of kinds of blood most cancers, together with AML and a number of myeloma. Gazyva continues to be investigated together with permitted and investigational molecules in CLL and follicular lymphoma.

Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It’s collectively commercialized by the businesses in the USA and commercialized by AbbVie outdoors of the USA.



Posted in: Drug Trial Information | Medical Situation Information

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Section 2 examine of ziresovir for treating hospitalized RSV contaminated infants achieves important progress


Ark Biosciences, a biotech firm creating proprietary therapeutics for viral an infection and respiratory ailments, introduced in the present day the numerous progress in its part 2 proof-of-concept examine of ziresovir within the remedy of hospitalized RSV contaminated infants. The unblinded medical efficacy outcomes of half 1 of the part 2 examine will probably be introduced on the 11th Worldwide RSV Symposium to be held in Asheville, North Carolina and additional particulars on progress on the sixth Worldwide Society for Influenza and different Respiratory Viruses Antiviral Group Convention – Advances in Respiratory Virus Therapeutics – to be held in Washington DC, USA in November.

The anti-RSV drug ziresovir, a novel RSV F-protein inhibitor, was found by Roche scientists, and was licensed to Ark Biosciences in 2014. Ark Biosciences has accomplished a number of medical research with the compound, together with two part 1 medical research in wholesome grownup volunteers in Australia and China, a part 1 human mass steadiness examine in the UK. Ark has additionally been conducting a worldwide part 2 PoC medical trial of ziresovir entitled VICTOR (Viral Inhibition in Youngsters for Remedy of RSV). The examine is “A Randomised, Double-blind, Placebo-controlled, 2-Half Examine of Orally Administered AK0529 to Consider the Security, Tolerability, Pharmacokinetics and Antiviral Impact of Single and A number of Dosing in Hospitalized Infants with Respiratory Syncytial Virus An infection”. Within the examine ziresovir is being investigated for its security and medical efficacy in infants hospitalized for decrease respiratory tract an infection with naturally acquired RSV an infection.

“Now we have made an ideal progress within the medical improvement of ziresovir as first-line antiviral remedy for the remedy of RSV contaminated sufferers, particularly hospitalized infants, which is the place the best unmet medical want exists,” stated Dr Jim Z. Wu, founder and CEO of Ark Biosciences. “We stay up for sharing the promising security and medical efficacy information from our part 2 VICTOR examine with the medical neighborhood on the upcoming worldwide conferences.”

Dr Stephen Toovey, MD PhD, Chief Medical Officer of Ark Biosciences, commented that, “There is a gigantic want for brand new medicines to deal with the hundreds of thousands of pediatric and aged sufferers that suffer RSV an infection yearly. Within the accomplished first a part of the part 2 VICTOR examine for the remedy of infants hospitalized with RSV an infection, for the primary time ever, an antiviral agent, ziresovir, has demonstrated glorious security profile and a transparent dose-dependent medical efficacy, decreasing sufferers’ indicators and symptom scores. We stay up for reporting these thrilling medical leads to the upcoming 11th Worldwide RSV Symposium in Asheville and the sixth Worldwide Society for Influenza and different Respiratory Viruses Antiviral Group Convention – Advances in Respiratory Virus Therapeutics in Washington DC.”

With the event of ziresovir, Ark goals to be the trade chief in anti-RSV drug improvement, and to develop the first-in-disease anti-RSV drug to fulfill the extraordinarily massive unmet medical want posed by RSV an infection.



Examine highlights accuracy of DecisionDx-Melanoma prognostic take a look at in sufferers with Stage II-IIIA melanoma


Fortress Biosciences, Inc., the pores and skin most cancers diagnostics firm offering molecular diagnostics to enhance most cancers administration choices, in the present day introduced the presentation of information highlighting how the accuracy of the DecisionDx®-Melanoma gene expression profile (GEP) take a look at in sufferers with Stage II and IIIA melanoma can enhance adjuvant scientific trial design on the 2018 Society for Melanoma Analysis Worldwide Congress held in Manchester, England from October 24-27.

The research titled, “Implications of a 31-gene expression profile take a look at for cutaneous melanoma on AJCC-based danger evaluation and adjuvant remedy trial design,” was introduced as a poster on the assembly.

Examine Background

  • The adjuvant therapy setting for melanoma has skilled vital advances lately. Whereas therapies present clear advantages for a subset of melanoma sufferers, additionally they will be related to vital adversarial results. Correct evaluation of particular person affected person danger is more and more vital to information therapy choices, particularly for these with no proof of illness.
  • The evaluation targeted on using the DecisionDx-Melanoma take a look at to tell which Stage II and IIIA melanoma sufferers are at excessive danger of recurrence and may benefit from adjuvant remedy. Adjuvant remedy trials are being thought-about or underway for Stage II and Stage IIIA sufferers, however recurrence charges on this inhabitants make trials on this inhabitants difficult.
  • The research assessed whether or not the DecisionDx-Melanoma take a look at might have a job in affected person choice for future adjuvant remedy scientific trials, and evaluated the potential price financial savings related to affected person enrollment based mostly on danger evaluation.

Examine Particulars and Key Findings

  • The DecisionDx-Melanoma take a look at was beforehand validated in a cohort of 690 sufferers from 18 facilities to precisely predict 5-year danger of recurrence for sufferers with melanoma (Class 1A lowest danger; Class 2B highest danger).
  • This evaluation included a subset of 173 sufferers who had Stage II or IIIA melanoma (restaged utilizing American Joint Committee on Most cancers [AJCC] eightth version).
  • Sufferers within the Stage II-IIIA cohort who had a Class 1A DecisionDx-Melanoma take a look at end result had a 5-year melanoma-specific survival (MSS) price of 100%, just like the danger of sufferers with Stage 1A melanoma. Stage II-IIIA sufferers who had a Class 2B end result had an MSS of 85%, just like a Stage IIIB danger.
  • Equally, 5-year recurrence-free survival for sufferers within the Stage II-IIIA cohort who had a Class 2B DecisionDx-Melanoma take a look at end result was 39% and distant metastasis-free survival was 54%, considerably decrease than these for sufferers with a Class 1A end result.
  • Examine outcomes confirmed that utilizing the DecisionDx-Melanoma take a look at to pick sufferers for a scientific trial, pattern measurement may very well be decreased by 36% with an total discount in trial prices if enrollment targeted on sufferers with a excessive danger of recurrence as decided by a DecisionDx-Melanoma Class 2B end result.

“Optimization of adjuvant scientific trial enrollment for melanoma is more and more vital given the adversarial results which can be related to present focused and immune checkpoint therapies,” mentioned Sancy Leachman M.D., Ph.D., Professor and chair, Division of Dermatology and Director, Melanoma Analysis Program, Oregon Well being & Science College. “These information help utility of the DecisionDx-Melanoma take a look at to establish Stage II-IIIA sufferers who’re at larger danger for recurrence and metastasis and are due to this fact acceptable candidates for adjuvant remedy consideration in a scientific trial.”


Posted in: Drug Trial Information | Medical Situation Information

Tags: Adjuvant Remedy, Most cancers, Carcinoma, Cell, Medical Trial, Dermatology, Diagnostics, Gene, Gene Expression, Genes, Laboratory, Lymph Node, Melanoma, Metastasis, Molecular Diagnostics, pH, Analysis, Pores and skin, Pores and skin Most cancers, Tumor