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Details:
The data showed positive safety, tolerability and biological activity of a 13-day dosing regimen conducted in Q2 2021 for intranasal Ampligen® (rintatolimod) in healthy subjects.
Lead Product(s): Rintatolimod,Interferon Alfa-2B
Therapeutic Area: Infections and Infectious Diseases Product Name: Ampligen
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 08, 2022
Details:
Ampligen is AIM’s dsRNA product candidate being developed for globally important cancers, viral diseases and disorders of the immune system. Ampligen has demonstrated in the clinic the potential for standalone efficacy in a number of solid tumors.
Lead Product(s): Rintatolimod,Interferon Alfa-2B,Paclitaxel
Therapeutic Area: Oncology Product Name: Ampligen
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Roswell Park Comprehensive Cancer Center
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 14, 2022
Details:
Ampligen (rintatolimod) is AIM’s dsRNA product candidate being developed for globally important cancers, viral diseases and disorders of the immune system.
Lead Product(s): Rintatolimod,Interferon Alfa-2B,Celecoxib
Therapeutic Area: Oncology Product Name: Ampligen
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Roswell Park Comprehensive Cancer Center
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 30, 2022
Details:
The preliminary data from uncontrolled clinical trial found that patients reported statistically significant improvements in chronic fatigue after treatment with an immuno-modulator Ampligen (rintatolimod).
Lead Product(s): Rintatolimod,Interferon Alfa-2B
Therapeutic Area: Infections and Infectious Diseases Product Name: Ampligen
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 28, 2022
Details:
Ampligen® (rintatolimod) has demonstrated promising activity as a potential maintenance therapy after systemic chemotherapy in patients with metastatic and locally advanced pancreatic cancer (LAPC).
Lead Product(s): Rintatolimod,Interferon Alfa-2B,Celecoxib
Therapeutic Area: Oncology Product Name: Ampligen
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 20, 2022
Details:
Ampligen® (rintatolimod), is an immuno-modulator with broad spectrum activity being developed for globally important cancers, viral diseases and disorders of the immune system.
Lead Product(s): Rintatolimod,Interferon Alfa-2B
Therapeutic Area: Infections and Infectious Diseases Product Name: Ampligen
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2022
Details:
Ampligen (rintatolimod) sterile solution is indicated for the treatment of severely debilitated patients with chronic fatigue syndrome (cfs) who have been diagnosed for longer than one year.
Lead Product(s): Rintatolimod,Interferon Alfa-2B,Paclitaxel
Therapeutic Area: Oncology Product Name: Ampligen
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 24, 2022
Details:
AP-003 is an anti-viral, recombinant human interferon alpha-2b product proven to be an effective treatment against COVID-19 successfully completed the Phase 1 portion of the Phase 1-2 randomized placebo controlled trial.
Lead Product(s): Interferon Alfa-2B
Therapeutic Area: Infections and Infectious Diseases Product Name: AP-003
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 29, 2021
Details:
Studies are ongoing to validate preliminary results and to test rhIFN⍺2b activity against Gamma (Brazil), Lambda (Peru), and the recent C.1.2 (South Africa) variant which contains mutations associated with increased transmissibility and the ability to evade antibodies therapy.
Lead Product(s): Interferon Alfa-2B
Therapeutic Area: Infections and Infectious Diseases Product Name: AP-003
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2021
Details:
The trial tests BetterLife’s proprietary inhaled interferon alpha-2b product, AP-003 administered via nebulizer. AP-003, being a Type I interferon, is a broad acting antiviral agent used in COVID-19 patients.
Lead Product(s): Interferon Alfa-2B
Therapeutic Area: Infections and Infectious Diseases Product Name: AP-003
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Pontificia Universidad Catolica de Chile
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 22, 2021
Details:
These in-vitro anti-viral studies of AP-003 against the Delta variant are a follow on to earlier in-vitro studies conducted at UWO which have shown potent and similar anti-viral activity of AP-003 against the COVID-19.
Lead Product(s): Interferon Alfa-2B
Therapeutic Area: Infections and Infectious Diseases Product Name: AP-003
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 25, 2021
Details:
The IFN-a2b treatment arms will receive BetterLife’s proprietary inhaled IFN-a2b product, AP-003, administered via nebulizer, twice daily for 10 days.
Lead Product(s): Interferon Alfa-2B
Therapeutic Area: Infections and Infectious Diseases Product Name: AP-003
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Altum Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 27, 2021
Details:
The rhIFN⍺2b, a Type I interferon, is a naturally occurring protein integral to the body’s first line of anti-viral defenses. There is evidence that coronaviruses, have mechanisms which suppress IFN⍺2b production, allowing the virus to evade the immune system and replicate.
Lead Product(s): Interferon Alfa-2B
Therapeutic Area: Infections and Infectious Diseases Product Name: AP-003
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 15, 2021
Details:
Altum Pharmaceuticals has entered into a Letter of Intent with Pontificia Universidad Católica de Chile to conduct a randomized placebo-controlled trial (“IN2COVID”) in COVID-19 patients testing Altum’s proprietary inhaled interferon alpha-2b product, AP-003.
Lead Product(s): Interferon Alfa-2B
Therapeutic Area: Infections and Infectious Diseases Product Name: AP-003
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 11, 2021
Details:
In a regulatory filing, Zydus Cadila has received approval from the DCGI to start the phase 3 clinical trials in COVID-19 patients with its biological therapy Pegylated Interferon alpha-2b or PegiHep.
Lead Product(s): Interferon Alfa-2B
Therapeutic Area: Infections and Infectious Diseases Product Name: PegiHep
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 03, 2020
Details:
BetterLife Pharma has selected Florence Healthcare to provide its electronic Trial Master File for AP-003 trial. The Florence platform will simplify and accelerate forthcoming clinical trial by enabling direct remote connections to the Company’s research sites and partners.
Lead Product(s): Interferon Alfa-2B
Therapeutic Area: Infections and Infectious Diseases Product Name: AP-003
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: BetterLife Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership November 04, 2020
Details:
In preparation of the Company's preparing human clinical trials of AP-003, the company will obtain trial consent virtually and the trial will be conducted via telemedicine from the participant’s home.
Lead Product(s): Interferon Alfa-2B
Therapeutic Area: Infections and Infectious Diseases Product Name: AP-003
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 28, 2020
Details:
Recruitment has begun in Roswell Park Comprehensive Cancer Center's Phase 1/2a clinical study of the effectiveness of rintatolimod (Ampligen) in combination with interferon alpha-2b in treating cancer patients with mild or moderate COVID-19 infection.
Lead Product(s): Rintatolimod,Interferon Alfa-2B
Therapeutic Area: Infections and Infectious Diseases Product Name: Ampligen
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 16, 2020
Details:
Under the agreement, AIM will provide Ampligen samples, in order to get it tested as a potential adjuvant therapy for COVID-19, for various research projects.
Lead Product(s): Rintatolimod,Interferon Alfa-2B
Therapeutic Area: Infections and Infectious Diseases Product Name: Ampligen
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Shionogi
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement July 06, 2020
Details:
Zydus will conduct an open-label, randomized, comparator controlled study of Pegylated IFN alfa-2b to evaluate safety, efficacy and tolerability in patients with COVID-19.
Lead Product(s): Interferon Alfa-2B
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 06, 2020
Details:
Company has filed a provisional patent application for, among other discoveries, the use of its experimental drug Ampligen® as a potential early-onset therapy for the treatment of COVID-19 induced chronic fatigue, which shows similarities to ME/CFS.
Lead Product(s): Rintatolimod,Interferon Alfa-2B
Therapeutic Area: Immunology Product Name: Ampligen
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2020
Details:
The new clinical trial to be conducted will test the safety of Ampligen (rintatolimod), in combination with interferon alfa-2b in patients with cancer and mild to moderate COVID-19.
Lead Product(s): Rintatolimod,Interferon Alfa-2B
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 14, 2020
Details:
The study investigated the use of interferon alpha-2b on 77 patients with moderate cases of COVID-19 and found that the interferon alpha-2b drug significantly accelerated clearance of the virus from the airways of patients.
Lead Product(s): Interferon Alfa-2B
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 13, 2020
Details:
Results from a recent trial suggests a significantly shorter time to viral clearance for patients treated with interferon alpha 2b (IFN?2b) compared to the group who received arbidol alone.
Lead Product(s): Interferon Alfa-2B
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 11, 2020
Details:
The data from this small-sample clinical study showed that danoprevir combined with ritonavir is safe and well tolerated in all patients.
Lead Product(s): Danoprevir,Ritonavir,Interferon Alfa-2B
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 25, 2020
Details:
All 11 patients receiving oral Ganovo and Ritonavir combination therapy have been discharged as they satisfy the discharge standards under the "Diagnosis and Treatment Program for Novel Coronavirus.
Lead Product(s): Danoprevir,Ritonavir,Interferon Alfa-2B
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 10, 2020
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