Stage 2

FibroGen Announces Completion of the Pamrevlumab Arm in Precision Promise, Pancreatic Cancer Action Network’s Phase 2/3 Adaptive Platform Trial for Metastatic Pancreatic Cancer

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星期四, 一月 25, 2024
Pancreatic Cancer Action Network, Biomarker, Patient, JD, Progression-free survival, SAN, Stage 2, Gemcitabine, MBA, Genomics, PFS, FDA, Pamrevlumab, Pancreatic cancer, Pharmaceutical industry

Pamrevlumab is the first experimental arm to meet its required threshold for graduation to Stage 2 in the adaptive platform trial.

Key Points: 
  • Pamrevlumab is the first experimental arm to meet its required threshold for graduation to Stage 2 in the adaptive platform trial.
  • The pamrevlumab arm of the study completed Stage 2 of the trial in January 2024.
  • PanCAN’s Precision PromiseSM adaptive platform trial ( NCT04229004 ) is a U.S.-based, seamless Phase 2/3 study that enrolled patients in approximately 24 sites around the country.
  • The pamrevlumab experimental arm was offered to patients with mPDAC as either a first-line (1L) or second-line (2L) treatment option.

Adagene Presents Interim Results Reinforcing Best-in-Class Profile of Masked anti-CTLA-4 SAFEbody® ADG126 (muzastotug) in Combination with Pembrolizumab in Metastatic Microsatellite-stable (MSS) Colorectal Cancer (CRC)

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星期二, 一月 16, 2024
Endometrial cancer, Patient, Therapy, Associate, MD, City, MSS, SAN, Liver disease, ASCO, Merck & Co., Poster, Stage 2, Clinical research, Society, Research fellow, Immunotherapy, FACP, Cervical cancer, PRS, PFS, Safety, Liver, Observation, CRC, Pembrolizumab, NCCC, Merck, Physician, Oncology, Pharmaceutical industry

SAN DIEGO and SUZHOU, China, Jan. 16, 2024 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced data from its presentation at the American Society of Clinical Oncology (ASCO) 2024 Gastrointestinal (GI) Cancers Symposium, taking place January 18-20 in San Francisco.

Key Points: 
  • “These promising data support further evaluation of this potential best-in-class anti-CTLA-4 antibody, ADG126, in combination with pembrolizumab for MSS CRC patients, including battling new liver lesions in those patients initially without detectable liver metastasis.
  • One of the patients had PD-1 refractory cervical cancer and the other had endometrial cancer.
  • The durable clinical activity of ADG126 in combination with pembrolizumab will continue to be evaluated as a larger cohort of subjects becomes evaluable at the 10 mg/kg Q3W dose level.
  • The clinical profile of ADG126 in combination with pembrolizumab presents a great opportunity for MSS CRC patients that otherwise have limited immunotherapy options available.”

HealthSnap and UnityPoint Health Announce Systemwide Virtual Care Management Partnership Expansion

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星期四, 一月 11, 2024
Obesity, Chronic care management, RPM, Patient, Internal medicine, MD, Hypertension, Mercury (element), Partnership, CCM, Stage 2, Heart failure, UnityPoint Health, Type, Blood pressure, Nursing

MIAMI, Jan. 11, 2024 /PRNewswire/ -- HealthSnap, a leading virtual care management platform, and UnityPoint Health, the nation's fifth-largest non-denominational health system, announced today the continued expansion of their partnership, which went live in January 2023. As one of the nation's most integrated health systems, UnityPoint Health serves nearly 8 million patient visits per year throughout Iowa, western Illinois, and southern Wisconsin.

Key Points: 
  • MIAMI, Jan. 11, 2024 /PRNewswire/ -- HealthSnap , a leading virtual care management platform, and UnityPoint Health , the nation's fifth-largest non-denominational health system, announced today the continued expansion of their partnership, which went live in January 2023.
  • The partnership, which includes both HealthSnap's Remote Patient Monitoring (RPM) and Chronic Care Management (CCM) programs has successfully been delivered to over 25,000 UnityPoint Health patients across Iowa and Illinois.
  • "UnityPoint Health is focused on providing easier and more personalized care for all those we serve, and by partnering with HealthSnap, we are able to seamlessly implement virtual care management programs for our patients living with chronic conditions," said Patricia Newland, MD, President of UnityPoint Clinic.
  • "We are thrilled to be expanding our partnership with UnityPoint Health and integrating our virtual care management programs across their patient population," said HealthSnap Co-Founder & CEO, Samson Magid.

Compass Therapeutics Provides Corporate Update

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星期五, 一月 5, 2024
Patient, CRC, Stage 2, IND, FDA, BTC, Research and development, PD-1, DLL4, CD137, PET, Melanoma, MD, Doctor of Philosophy, Therapy, Mesothelioma, Paclitaxel, Carcinoma, SCLC, Safety, Development, NSCLC, PD-L1, Pharmaceutical industry

As previously disclosed, effective January 9, 2024, Vered Bisker-Leib, PhD, Compass President and COO, will lead Compass as Compass Chief Executive Officer and join the Compass board of directors.

Key Points: 
  • As previously disclosed, effective January 9, 2024, Vered Bisker-Leib, PhD, Compass President and COO, will lead Compass as Compass Chief Executive Officer and join the Compass board of directors.
  • Effective January 9, 2024, Thomas Schuetz, MD, PhD, Compass’ Scientific Founder and Chief Executive Officer will transition to President of Research and Development and be appointed Vice Chair of the Compass board of directors.
  • BOSTON, Jan. 05, 2024 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, today reported a business update.
  • Thomas Schuetz, MD, PhD, Compass’ Scientific Founder and current Chief Executive Officer will transition to President of Research and Development and assume the role of Vice Chair of the Compass board of directors.

Viracta Therapeutics Provides Clinical Update and Outlook for 2024

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星期四, 一月 4, 2024
SDD, NPC, Food, Stage 2, Nasopharyngeal carcinoma, Lymphoma, DLBCL, FDA, PTLD, ODD, SAN, Therapy, Peripheral T-cell lymphoma, Patient, PTCL, Pharmaceutical industry

SAN DIEGO, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today provided a clinical update, including its roadmap for advancing Nana-val’s clinical development in 2024. Nana-val (nanatinostat in combination with valganciclovir), is the company’s all-oral investigational therapy targeting Epstein-Barr virus-associated cancers.

Key Points: 
  • Complete enrollment of Stage 2 in the R/R EBV+ peripheral T-cell lymphoma (PTCL) cohort of patients treated with Nana-val (n=11) in the first quarter of 2024.
  • Present Stage 2 data from patients with R/R EBV+ PTCL in the second half of 2024.
  • Report Stage 1 data from patients with R/R EBV+ diffuse large B-cell lymphoma (DLBCL) and R/R EBV+ post-transplant lymphoproliferative disorder (PTLD) by year-end 2024.
  • Best responses through the fifth dose cohort included two confirmed partial responses and five stable diseases out of 17 patients.

Oculis Announces First Patient First Visit in Phase 3 DIAMOND-1 Trial of OCS-01 Eye Drop in Diabetic Macular Edema

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星期一, 十二月 18, 2023
Stage 2, DME, Pain, Macular edema, Inflammation, University, CST, Week, OCS, Telecanthus, University of Nevada, Reno, Patient, Safety, Diabetic retinopathy, Paratriathlon, Pharmaceutical industry

DIAMOND-1 (DIAbetic Macular edema patients ON a Drop) is a Phase 3, two-stage, double-masked, randomized, multi-center trial to assess the efficacy and safety of OCS-01 eye drops in DME patients.

Key Points: 
  • DIAMOND-1 (DIAbetic Macular edema patients ON a Drop) is a Phase 3, two-stage, double-masked, randomized, multi-center trial to assess the efficacy and safety of OCS-01 eye drops in DME patients.
  • The primary objective of the 3-month Stage 1 was to select the optimal dosing regimen (n=148).
  • Furthermore, 27.4% of patients in the OCS-01 group achieved ≥15-letter improvement in BCVA from baseline vs. 7.5% in the vehicle group at Week 12 (p=0.009).
  • OCS-01 eye drops have emerged as a potential solution for this unmet need, and the encouraging results from Stage 1 of the DIAMOND-1 Phase 3 trial support this outlook.

Rhythm Pharmaceuticals Announces Updates on MC4R Pathway Programs at R&D Event

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星期三, 十二月 6, 2023
Bardet–Biedl syndrome, Quality of life, Genotype, Food, Stage 2, Hyperpigmentation, Life, Shanda, Polyphagia, FDA, Type, Weight loss, POMC, BMI, European, Disease, MC1R, University of Florida, MD, Pediatric endocrinology, New Drug Application, University, SIM1, Obesity, TBX3, Endocrinology, PCSK1, Human, Patient, Proopiomelanocortin, Hunger, BBS, LEPR, Pharmaceutical industry

-- Company to host R&D webcast today at 8:00 a.m. ET--

Key Points: 
  • “Today, we are excited to showcase our commitment to understanding the MC4R pathway and developing the next generation of therapies,” said David Meeker, M.D., Chair, President and Chief Executive Officer of Rhythm.
  • The hyperphagia and severe obesity of rare genetically-caused MC4R pathway diseases can present early in life, and these data show potential efficacy in patients younger than 6.
  • A live webcast of the R&D call will be available under "Events and Presentations" in the Investor Relations section of the Rhythm Pharmaceuticals website at https://ir.rhythmtx.com/ .
  • The archived webcast will be available on Rhythm Pharmaceuticals’ website approximately two hours after the conference call and will be available for 30 days following the call.

Connect Biopharma Announces Positive Long-Term Data from the China Pivotal Trial of Rademikibart in Patients with Moderate-to-Severe Atopic Dermatitis

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星期二, 十一月 21, 2023
Patient, Entrepreneurship, Stage 2, CNTB, SAN, Simcere Pharmaceutical, Week, IGA, Safety, Pharmaceutical industry

These results follow the previously reported Stage 1 results of the trial, which met all primary and key secondary endpoints.

Key Points: 
  • These results follow the previously reported Stage 1 results of the trial, which met all primary and key secondary endpoints.
  • “This study demonstrated that rademikibart has a best-in-class potential, and if approved as a Q4W treatment, we believe could offer patients with AD a highly efficacious treatment with less frequent dosing than current approved treatments.
  • I’d like to thank the patients, their families, the clinical and manufacturing teams, and all of our vendors that were an integral part of this trial.
  • Patients that did not achieve EASI-50 (non-responders) were assigned to an open label Q2W rademikibart arm (n=86).

Boomerang Medical's IBD Neuromodulation Study Successfully Completes Enrollment Milestone

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星期三, 十二月 20, 2023
Alternative Medicine, Health, FDA, Medical Devices, Health Technology, Clinical Trials, Biotechnology, Endoscopy, IBD, Stage 2, Constipation, Multimedia, Physician, Medicine, Research, Diarrhea, Inflammatory bowel disease, Patient satisfaction, Colonoscopy, Abdominal pain, Clinical trial, Trial of the century, University, MPH, Patient, Ulcerative colitis, Pharmaceutical industry

Boomerang Medical, Inc., a women-led bioelectronic medicine company focused on autoimmune diseases, proudly announced the completion of Stage 2 of its FDA-approved pilot study.

Key Points: 
  • Boomerang Medical, Inc., a women-led bioelectronic medicine company focused on autoimmune diseases, proudly announced the completion of Stage 2 of its FDA-approved pilot study.
  • This milestone marks a significant advance in the company’s research as it progresses towards its pivotal study.
  • “This study represents a promising step forward in the quest for expanding the armamentarium for managing IBD.
  • Heather Simonsen, CEO of Boomerang Medical, commented on the recent milestone: “Successfully completing the Stage 2 enrollment for our BOOM-IBD Clinical Trial is a significant step in our research trajectory.

Oculis Reports Q3 2023 Financial Results and Provides Company Update

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星期三, 十一月 15, 2023
NDA, Dexamethasone, Safety, PSME, Business analyst, Telecanthus, Visual acuity, DED, CME, International, AON, IND, Investment, Uveitis, Bank statement, Net, Patient, Research, DME, Week, Hierarchy, Inflammation, Genotype, Pain, UME, Stage 2, SNP, TNF, CHF, POC, CST, International Financial Reporting Standards, OCS, Pharmaceutical industry, Life insurance, Pecten oculi, Ophthalmology

ZUG, Switzerland and BOSTON, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS) (“Oculis” or the “Company”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, today announced third quarter financial results for the period ended September 30, 2023, and an overview of the Company’s progress.

Key Points: 
  • ZUG, Switzerland and BOSTON, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS) (“Oculis” or the “Company”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, today announced third quarter financial results for the period ended September 30, 2023, and an overview of the Company’s progress.
  • Oculis anticipates first patient enrollment toward the end of 2023 and beginning of 2024 in all three pivotal trials.
  • Oculis is on track to deliver the first patient first visit before the end of 2023 with clinical data readout expected in mid-2024.
  • The Company’s management uses these measures to better analyze its financial results and better estimate its financial outlook.