PRODUCT: AntiCovir (AP-003)
INDICATION: Early stage COVID-19
STATUS: Randomized, double-blind, placebo controlled trial, powered for Phase 3 registration
AREA: HPV GENITAL (Female)
INDICATION: HPV Cervical High grade intraepithelial lesion (HSIL)
STATUS: Randomized, double-blind Phase 2b to start Q1 2021
AREA: Solid Tumors with Bone Metastases or at Risk of Bone Metastases
INDICATION: Solid tumors (with focus on breast, lung and prostate cancers)
STATUS: Phase 1-2 [NCT04143789]; Ongoing
IFNa2b has been used to treat COVID 19 in China.² Subject to receiving marketing authorization, AP-003 could potentially be used to treat patients early after COVID 19 infection which may potentially prevent the progression to severe disease and need for hospitalization.³
SARS CoV 2 coronavirus causes COVID 19. SARS CoV viruses block interferon production in infected cells, allowing the virus to continue replicating unabated ¹.
Treatment with interferon may overcome that block, potentially restoring cells normal anti viral activity.
Interferon alpha 2b (IFNa2b) is a potential treatment for COVID 19 ².
IFNa2b (inhaled) has been used in China on COVID 19 patients.
AP-003 may be given by inhalation at the first signs of COVID 19 with following projected outcomes according to Altum Clin Protocol ALT 003 COV 01 2020 05 04 rationale:
AP-002 is a novel, orally bioavailable gallium based small molecule NCE. In contrast to currently available bone modifying agents, AP-002 uniquely has both anti-bone resorption and direct anti-tumor cell killing activity. This positions it ideally to treat cancer metastatic to the bone. Bone metastases often result in severe pain, spinal cord compression and cancer-induced bone fractures, collectively referred to as skeletal related events (SREs). A life threatening consequence of cancer induced bone resorption is hypercalcemia of malignancy.
The present treatments for cancer-induced bone resorption conditions are either bisphosphonates (e.g. zoledronic acid; Zometa®) or the anti-RANKL MAb, denosumab (Xgeva®). Both have undesirable side effects, both need administration by healthcare professionals (intravenous or subcutaneous), and neither of them have direct anti-tumor activity. In a recent large (4,500 patient) placebo controlled trial in breast cancer, denosumab failed to improve survival.
Wang et al. 2018: AP-002: A novel inhibitor of osteoclast differentiation and function without disruption of osteogenesis. American Society Bone & Mineral Research (ASBMR) Annual Conference 2018
AP-001 is a topical delivery system that incorporates interferon alpha-2b in Altum’s patented BiPhasix™ technology. The BiPhasix system uniquely enables efficient delivery of biomolecules across the mucosa.
Interferon alpha-2b is a potent, broad acting anti-viral agent, with established anti-HPV activity. Intron A® is approved for treatment of HPV induced genital warts (condylomata acuminate). Treatment requires intra-lesional injections three times a week. This administration makes it very difficult to use in indications such as HPV-cervical neoplasia, where lesions are not readily visible and the multiple local injections impair patient quality of life on many levels. There is also the cost and inconvenience of repeated healthcare professional visits for the injections. Intron A has therefore not been developed in this indication. Intravenous interferon results in systemic toxicities which precludes its use for treatment of cervical HPV. HPV-cervical dysplasia is a local disease ideally treatment with the local delivery of interferon alpha-2b. The delivery should be easy to use and self-administered at home and safe, without systemic and local side effects). AP-001 is intended to fulfill this need.
AP-001 is a self-administered intra-vaginal cream. It fills the vagina in proximity to the cervix following self- administration. The product’s viscosity prevents vaginal leakage of the cream following administration, thereby allowing prolonged coating the cervix for optimal drug delivery. AP-001 has completed Phase 1 and Phase 2 clinical trials, where it was shown to be active (in cervical neoplasia regression) and safe (no systemic or local side effects). A randomized Phase 2b clinical trial in HPV-cervical CIN2/3 patients is projected to be initiated by Q1 2021.
Clinical Outcome of Topical Interferon Alpha-2b Cream in Phase II Trial for LSIL/CIN 1 Patients – PDF
Stabilization of Interferon alpha-2b in a Topical Cream – PDF
By design, the skin is a formidable barrier to penetration by external agents. In order to reach their target site within the underlying layers of the skin or beyond the skin to the systemic circulation, topical drugs must first penetrate the stratum corneum, the outermost layer of the skin. It is this layer which is considered to be the rate-limiting barrier to drug absorption.
The goal is to have a safe delivery system that does not irritate or damage the skin barrier after repeated usage in patients.
Altum is developing its proprietary BiPhasix™ liposomal delivery system which has greatly improved the features of traditional liposomes. In contrast to traditional liposomes that entrap a single, aqueous phase, our system is a complex system where the lipid bilayers entrap both aqueous and oil phases in the form of a stabilized emulsion.
BiPhasix™ is constructed with multi-compartmental lipid vesicles. BiPhasix™ makes it possible to achieve greater formulation versatility than previously attainable with traditional creams, gels or ointments – or even conventional liposomal delivery systems. Thus, BiPhasix™ dermal delivery system combines the advantages of liposomes and micro-emulsions, offering a wider range of formulation options for a variety of drug substances:
The lead product from the BiPhasix™ platform is AP-001.
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