Drug
company Phase I trials are the domain of those people who claim to make a living as scientific subjects (check out a Wired feature on them here).
Not exact matches
So, at the end of the day, are
companies simply flocking to disease areas like oncology, and rare diseases — which have low chances of approval from
phase one
trials due to their complexities but carry high margins and high rewards if they do cross the regulatory finish line — at the expense of other conditions?
In November, the
company announced that the results of a
Phase III
trial of solanezumab «were not what we had hoped for.»
According to PhRMA, there are more than a dozen experimental treatments that are still in
phase 3, the latest stage of clinical
trials before
companies present their data to the FDA.
The
company's lead product candidate, dilanubicel (NLA101), is currently being evaluated in two ongoing
Phase 2 clinical
trials in adult and pediatric patients with hematologic malignancies undergoing an allogeneic transplant and adult patients receiving high dose chemotherapy for Acute Myeloid Leukemia.
The
company's leading program, a differentiated PPAR gamma agonist (MIN - 102) that has multiple CNS indications, has successfully completed a
phase 1 clinical
trial and is ready to move into a
phase 2/3 study with adult AMN patients.
The
company's lead program, now in
phase I clinical
trials, is a differentiated PPAR gamma agonist (MIN - 102) that has potential in multiple CNS indications.
Cambridge, MA — March 30, 2017 — Aura Biosciences, a biotechnology
company developing a new class of therapies to target and selectively destroy cancer cells using viral nanoparticle conjugates, announced today that it has enrolled and dosed the first patient in its
Phase 1b clinical
trial of light - activated AU - 011, an investigational, first - in - class targeted therapy in development for the treatment of ocular melanoma, a rare and life - threatening disease.
The Rolls Royces of science experiments — relatively low risk and decent payoff — are
Phase I drug
trials conducted by pharmaceutical
companies.
At Amgen, the drug made it all the way to a
phase III clinical
trial before the
company pulled the plug partway through the
trial after concluding that the therapy was unlikely to help patients live longer.
The San Diego, California — based biotech
company MediciNova recently completed a
phase II
trial of a glia - inhibiting drug called ibudilast, already approved as an asthma treatment in Japan, to relieve pain and treat withdrawal in opioid abusers.
But the others are on their way: a handful of major pharmaceutical
companies have reached the last
phase of clinical
trials.
The
company plans in October to conduct a separate test specifically to study the seasonal flu vaccine's effectiveness among 480 elderly participants (a demographic often encouraged to get seasonal flu shots), and
Phase III efficacy
trials across a larger set of demographics are scheduled to begin early next year.
Targacept needs to succeed in only two of its
phase III
trials to gain approval, says Merouane Bencherif, head of preclinical research at the
company.
Chancellor notes that Forest Laboratories, based in New York, reported in January that its candidate antidepressant, levomilnacipran, had failed in a
phase III
trial, yet in July the
company announced that the drug had significantly improved symptoms in another
phase III
trial.
On November 8, Targacept, a drug
company based in Winston - Salem, North Carolina, announced that TC - 5214 had performed no better than placebo in one of four
phase III
trials.
The
company has already garnered a fair amount of attention and is funded by the US National Institutes of Health (NIH) in Bethesda, Maryland, to conduct a
phase II clinical
trial in people with pain conditions such as neuralgia, fibromyalgia or migraines.
In March, researchers, in collaboration with the pharmaceutical
company Ultragenyx, completed the first part of a
Phase III clinical
trial in adults with XLH — the final test of a drug before federal approval.
In conjunction with AesRx, a biotech
company in Newton, Massachusetts, and with NIH's National Heart, Lung, and Blood Institute, NCATS helped move the drug through to
phase II clinical
trials.
And it launched its first two
phase I
trials without announcing what diseases they targeted — a decision Bancel attributes to fears that financial markets would prematurely pigeonhole the
company into a particular field.
It showed effectiveness against liver cancer in a
phase II clinical
trial and will move into a
phase III
trial later this year, David Kirn, an oncologist and the
company's president and chief executive officer, said at a recent meeting of the American Society for Gene & Cell Therapy in Washington, D.C..
The plan is to predict very early which drugs are likely to succeed and which are not, and promote the winners rapidly to larger (
phase III)
trials, which most likely would be run by private
companies, without data sharing.
When Theravance, the
company in South San Francisco, California, that developed the drug, designed the large
phase III clinical
trials needed for approval, the FDA simply required a demonstration that the drug eliminated symptoms of infection as reliably as the approved antibiotic vancomycin.
Last week, Rib - X announced that it had raised US$ 18.7 million to help the
company start
phase III
trials of an antibiotic that could target skin infections.
«The next step is to figure out how to bring this finding into early -
phase clinical
trials with patients, and we're partnering with pharmaceutical
companies to explore this,» Goga said.
Afferent Pharmaceuticals today announced publication of results from a
Phase 2 clinical
trial demonstrating that the
company's novel drug candidate, AF - 219, reduced daytime cough frequency by 75 % compared to placebo in patients with treatment - refractory chronic cough.
The
Phase 2/3
trials will be sponsored by Vtesse, a new biotech
company that was formed specifically to evaluate the safety and efficacy of cyclodextrin for the treatment of NPC and ultimately obtain FDA labeling if the drug is effective.
International
companies invest heavily in local third -
phase clinical
trials but do not invest in basic research in Brazilian facilities.
The
company is looking ahead to
Phase II
trials and seeking an appropriate partner in the pharmaceutical industry.
ViaCyte is conducting a
Phase 1/2 clinical
trial of the
Company's lead product candidate VC - 01 in patients with type 1 diabetes who have minimal to no insulin - producing beta cell function.
Illustrating the tricky path current Alzheimer's research faces, the study was published literally hours after giant pharmaceutical
company Merck announced the cancellation of a
Phase 3 clinical
trial surrounding a drug that targets the exact same enzyme.
The
companies have launched a
phase II
trial of the antibody - drug conjugate, and are also testing it in other solid tumors, including ovarian and non — small - cell lung cancers.
What are the odds that a
company entering a
Phase 1
trial today can see its candidate all the way through a successful
Phase 3
trial?
The
company recently reported data from
Phase 1
trial.
The
company is sponsoring the ongoing
phase 1 clinical
trial.
Cambridge, MA, September 07, 2016 — Proclara Biosciences, a biotechnology
company developing novel therapies for diseases caused by protein misfolding, today announced that it has initiated a
Phase 1b clinical
trial evaluating NPT088, its lead development candidate for Alzheimer's disease.
Table 1: Selection, Design & Construction of HSV - based Oncolytic Viruses Table 2: Selection, Design & Construction of Adenovirus - based Oncolytic Viruses Table 3: Selection, Design & Construction of Vaccinia Virus - based Oncolytic Viruses Table 4: Selection, Design & Construction of Vesicular Stomatitis Virus - based Oncolytic Viruses Table 5: Selection, Design & Construction of Newcastle Disease Virus - based Oncolytic Viruses Table 6: Selection, Design & Construction of Various Virus - based Oncolytic Viruses Table 7: Current
Company - Sponsored Clinical
Trials of T - Vec Table 8: Clinical
Trials of ColoAd1 Table 9: Clinical
Trials with JX - 594 Table 10: Clinical
Trials with GL - ONC1 Table 11: Clinical
Trials of CAVATAK (CVA21) Table 12: Clinical
Trials with MV - NIS Table 13: Overview of Oncolytic Viruses by Development
Phase & Virus Family Table 14: Profile of Approved and Marketed Oncolytic Viruses Table 15: Pivotal Study Design of Oncolytic Viruses in Late Stage Development Based on Previous Clinical Results Table 16: Approved Indications of Immune Checkpoint Inhibitors Table 17: Active Clinical Studies of Oncolytic Viruses in Combination with Immune Checkpoint Inhibitors (ICI) Table 18: Planned Clinical Studies of Oncolytic Viruses in Combination with Immune Checkpoint Inhibitors (ICI) Table 19: Active or Planned Clinical Studies of Oncolytic Viruses in Combination with Other Anti-Cancer Therapeutics Table 20: Pattern of Transgenes in Oncolytic Viruses in Relation to Development
Phase Tables 21a and 21b: Indications and Frquency and Way of Administration of Oncolytic Viruses in Active and / or Positive Completed Clinical Studies Table 22: Small and Medium Pharma & Biotech as Partner for Regional Co-Development of Oncolytic Viruses Table 23: Immuno - Oncology Portfolio of Major Pharma & Biotech with Interest in Oncolytic Viruses Table 24: Interests of Major Pharma & Biotech in Oncolytic Viruses Table 25: First Generation Oncology Virus
Companies and their Sources of Technology Table 26: Second Generation Oncology Virus
Companies and their Sources of Technology Table 27: Third Generation Oncology Virus
Companies and their Sources of Technology Table 28: Fourth Generation Oncology Virus
Companies and their Sources of Technology Table 29: Grants, Credits & Donations Table 30: Financing by Venture Capital, Private Equity and Other Private Placements Table 31: Collaboration & Licensing Agreements Table 32:
Companies Listed on Stock Exchange & Offerings Table 33: Mergers & Acquisitions
Reykjavik, ICELAND, October 19, 2004 — deCODE genetics (Nasdaq: DCGN) today announced the principal results from its
Phase IIa information - rich clinical
trial ™ of DG031, the
company's developmental compound which is being studied for the prevention of heart attack.
The
company's lead proprietary compound, LMTX ®, has recently completed three
Phase 3 clinical
trials to evaluate its safety and efficacy in the treatment of Alzheimer's disease and behavioural - variant frontotemporal dementia.
San Diego, January 8, 2015 — ViaCyte, Inc., a privately - held regenerative medicine
company with the first stem cell - derived islet replacement therapy for the treatment of diabetes in clinical trials, has received a No Objection Letter from Health Canada providing clearance to proceed with sites in Canada for the Company's Phase 1/2 clinical trial of its VC - 01TM product can
company with the first stem cell - derived islet replacement therapy for the treatment of diabetes in clinical
trials, has received a No Objection Letter from Health Canada providing clearance to proceed with sites in Canada for the
Company's Phase 1/2 clinical trial of its VC - 01TM product can
Company's
Phase 1/2 clinical
trial of its VC - 01TM product candidate.
Paris, France, April 3, 2018, 5.35 pm CET — GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA - PME eligible), a biopharma
company focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced topline results from the REVERSE
Phase III clinical
trial evaluating the safety and efficacy of a single intravitreal injection of GS010 (rAAV2 / 2 - ND 4) in 37 subjects whose visual loss due to 11778 - ND4 Leber Hereditary Optic Neuropathy (LHON) commenced between 6 and 12 months prior to study treatment.
deCODE genetics (Nasdaq: DCGN) today announced that it has begun enrolling patients for its
Phase IIa clinical
trial for DG051, the
company's leukotriene A4 hydrolase inhibitor being developed for the prevention of heart attack.
Acucela is another
company with a drug candidate for Stargardt's disease in
Phase II clinical
trials.
And the
company just filed an application to begin
Phase I
trials of its ALAS - 1 targeting treatment for hepatic porphyrias (a class of rare inherited disorders that are the result of deficiencies in some enzymes of the liver), according to the release.
Reykjavik, ICELAND, January 9, 2008 — deCODE genetics (Nasdaq: DCGN) today announced positive topline results from its
Phase IIa clinical
trial for DG051, the
company's leukotriene A4 hydrolase inhibitor being developed for the prevention of heart attack.
The
company that sponsored the
Phase 3
trial, GW Pharmaceuticals, had already announced some of the results, but researchers said the full peer - reviewed study, published Wednesday in the New England Journal of Medicine, validated the importance of the research.
The
company says it plans to begin a
Phase 1/2 clinical
trial this year, which is also true of the unnamed grant applicant.
deCODE genetics (Nasdaq: DCGN) today announced positive top - line results from its
Phase I multiple dose clinical
trial of DG051, which the
company is developing for the prevention of heart attack.
CDP is a joint initiative between Cancer Research UK's Drug Development Office and Cancer Research Technology, to progress promising anti-cancer agents which pharmaceutical
companies do not have the resources to progress through early
phase clinical
trials.
Reykjavik, ICELAND, March 9, 2005 — deCODE genetics (Nasdaq: DCGN) today announced that it has begun enrolling subjects in a
Phase I clinical
trial for DG041, the
company's developmental compound for the treatment of atherosclerosis of the extremeties, commonly known...