Previous experiments had shown that bavituximab at the concentrations present in the blood has no effect on plaque formation (data not shown). During a long-term multiple dose phase II clinical trial, high doses of the three neutralizing antibodies were given in combination to 14 HIV-1-infected individuals at weekly intervals over three months. By giving the bavituximab group an addition injection with a standard anti-virus drug called ribavirin, the survival rate rose to 63%. At that point, a fatty molecule called phosphatidylserine, which is normally positioned on the cell wall’s internal surface, flips to the outside of the cell. Peregrine Pharmaceuticals. Chu, S. Patient cohorts received ascending dose levels of bavituximab weekly for up to 8 weeks.
Viruses often dodge drugs by mutating into a different form that the drug is ineffective against. Patient cohorts received ascending dose levels of bavituximab weekly for up to 8 weeks. In this study, the anti-viral effect of bavituximab was further augmented by the addition of the standard of care drug ribavirin, with 63% of animals receiving the combination therapy surviving the potentially lethal infection. No dose-limiting toxicities occurred and a maximum tolerated dose of bavituximab was not reached. The fully human anti-PS antibodies being used in Dr. Bavituximab helps reactivate and direct the body’s immune system to destroy infected cells and virus particles that exhibit this specific phospholipid on their surface. Approximately 8,000 to 10,000 people die every year from HCV-related liver disease.
Food and Drug Administration (“FDA”), the risk that results from the other randomized Phase II trial will not be consistent with results experienced in the earlier single-arm Phase II trial or support registration filings with the FDA, and the risk that Peregrine may not have or raise adequate financial resources to complete the planned clinical programs. IMAGING PROGRAM HIGHLIGHTS PS-Targeting Molecular Imaging Program Recently, Peregrine launched its experimental phosphatidylserine (PS)-targeting molecular imaging candidate, 124I-PGN650, for the imaging of multiple solid tumor types. May’06-Jan’16=$154.8mm), as well as support of Peregrine’s own product pipeline. A growing body of scientific publications, including Nature Medicine and The Journal of Experimental Medicine, has highlighted data on the role of PS and Peregrine’s PS-targeting therapies in infectious diseases. By masking the exposed PS, bavituximab and other anti-PS antibodies may block these effects and allow the body to develop a robust immune response to the viral pathogen. Primary endpoints include safety and pharmacokinetics, and secondary endpoints will measure HCV and HIV RNA by PCR. In previous preclinical studies funded by NIAID, bavituximab demonstrated encouraging anti-viral activity as a potential treatment for hemorrhagic fevers.
As a single agent, ipilimumab is approved as a second-line treatment, as well as adjuvant therapy for patients with completely resected melanoma. (NASDAQ: PPHM) today announced the completion of enrollment and randomization of 70 patients in a Phase II trial evaluating bavituximab in combination with gemcitabine versus gemcitabine alone in patients with previously untreated stage IV pancreatic cancer. Factors that could cause actual results to differ materially or otherwise adversely impact the company’s ability to obtain regulatory approval for its product candidates include, but are not limited to, uncertainties associated with completing preclinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products as all of our products are currently in development, preclinical studies or clinical trials; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. The patent also covers anti-viral immunoconjugate compositions, methods and other combinations of anti-phospholipid antibodies and anti-viral agents. Bavituximab is an investigational monoclonal antibody that targets PS. Baclofen relaxes muscles by blocking certain nerve receptors in the spinal cord. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc.
capabilities, are provided through its wholly-owned subsidiary Avid Bioservices, Inc. Thorpe reported that Bavituximab treatment appears to be well tolerated with few side effects. Acambis are investigating the technology, and Harvard continues to research the treatment. Philip Thorpe, a member of the Peregrine Scientific Resource Board and professor of pharmacology at the Univ. The results exhibited the DOUBLING of overall response rates and an improvement in progression-free survival in patients who received the treatment! It is also worth noting that PS can be modified by reactive oxygen species (ROS; a form of ‘phospholipid modifier’) to generate oxidized PS in certain cell types, a process that could aid PS externalization10, 11 and recognition by phagocytes.12 Figure 2. The European expert panel CHMP…
7 /PRNewswire-FirstCall/ — Peregrine Pharmaceuticals, Inc. HSV-1 is a form of the Herpes Simplex Virus that usually affects the lips or mouth, but can spread to the eyes or genitals. The drug, bavituximab, takes a novel tack in confronting viruses, which are notorious for mutations that evade or resist conventional pharmaceutical molecules.