PhaseBio Announces Case Study Highlighting PB1046 Hemodynamic Data Presented at the 14th Pulmonary Vascular Research Institute World Congress - Yahoo Finance
PhaseBio Announces Case Study Highlighting PB1046 Hemodynamic Data Presented at the 14th Pulmonary Vascular Research Institute World Congress - Yahoo Finance |
| Posted: 04 Feb 2020 12:00 AM PST Data continue to support potential of once-weekly VIP analogue for adults with pulmonary arterial hypertension MALVERN, Pa. and SAN DIEGO, Calif., Feb. 04, 2020 (GLOBE NEWSWIRE) -- PhaseBio Pharmaceuticals, Inc. (PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today announced presentation of data from a patient who received more than 18 months of treatment with PB1046, the company's first-in-class, sustained-release vasoactive intestinal peptide (VIP) analogue being evaluated for the treatment of patients with pulmonary arterial hypertension (PAH). The data, which were presented at the 14th Pulmonary Vascular Research Institute (PVRI) World Congress held in Lima, Peru, from January 30th through February 2nd 2020, demonstrate clinically-meaningful improvements in all of the hemodynamic parameters assessed, which were sustained for up to three months after the last dose was administered. The patient was part of PhaseBio's Phase 1b/2a pilot study which evaluated the multi-dose safety, pharmacokinetics (PK) and VIP-based pharmacodynamic effects of PB1046 in three PAH patients who have a permanently implanted hemodynamic monitor (CardioMEMS™ HF System), a device placed in the pulmonary artery (PA) which continuously measures heart rate along with systolic and diastolic pressures. PB1046 was administered subcutaneously on a weekly basis for eight weeks at dose levels previously tested and observed to have a favorable safety profile. All three patients completed the eight-week study with no drug-related serious adverse events and PB1046 appeared to be well tolerated with only mild injection site erythema. In one patient, the subject of the case study, treatment was extended for a total of 18 months, based on continued improvements in hemodynamic parameters. The CardioMEMS monitoring system detected reductions in mean PA pressure and total pulmonary resistance and increases in stroke volume and cardiac output without an increase in heart rate with PB1046. "We were pleased to see sustained positive long-term effects in an adult patient with PAH who had been treated with PB1046," said Raymond Benza, MD, cardiologist at the Allegheny Health Network in Pittsburgh, Pennsylvania. "We believe these data validate the continued evaluation of PB1046 in the ongoing Phase 2b clinical trial and underscore its potential to be a once-weekly treatment for PAH, a progressive and life-threatening orphan disease with no known cure." About PB1046 PB1046, a novel, subcutaneously-injected vasoactive intestinal peptide (VIP) analogue, is a recombinant fusion protein composed of VIP and PhaseBio's proprietary elastin-like polypeptide (ELP) biopolymer. Based on the pharmacokinetic profile of PB1046 observed in clinical trials, the fusion of VIP to ELP results in both a prolonged absorption profile and a longer circulating half-life, enabling once-weekly dosing. In addition to VIP-mediated vasodilation, PB1046 may suppress the adverse remodeling of blood vessels and increase cardiac contractility and relaxation. PB1046 has been administered to more than 70 patients with hypertension or a history of cardiovascular disease in three Phase 1/2 clinical trials conducted in the U.S., with no drug-related serious adverse events to date. The U.S. Food and Drug Administration has granted PB1046 orphan drug designation for the treatment of PAH (WHO Group 1 Pulmonary Hypertension) and cardiomyopathy associated with dystrophinopathies. About PhaseBio PhaseBio Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases. The company's pipeline includes: PB2452, a novel reversal agent for the antiplatelet therapy ticagrelor; PB1046, a once-weekly vasoactive intestinal peptide receptor agonist for the treatment of pulmonary arterial hypertension; and PB6440, an oral agent for the treatment of resistant hypertension. PhaseBio's proprietary ELP technology platform enables the development of therapies with potential for less-frequent dosing and improved pharmacokinetics, including PB1046, and drives both internal and partnership drug development opportunities. PhaseBio is located in Malvern, PA and San Diego, CA. For more information, please visit www.phasebio.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning or implying the conduct or timing of our clinical trials and our research, development and regulatory plans for PB1046 and the potential for PB1046 to be disease-modifying. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission filings, including in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2019. These forward-looking statements speak only as of the date hereof, and PhaseBio Pharmaceuticals, Inc. disclaims any obligation to update these statements except as may be required by law. Investor Contact: Media Contact:   |
| You Can (Usually) Still Travel With Pulmonary Hypertension - Health Essentials from Cleveland Clinic Posted: 03 Apr 2019 12:00 AM PDT Pulmonologist Neal Chaisson, MD, believes travel can help patients with pulmonary hypertension continue to live a full life. Cleveland Clinic is a non-profit academic medical center. Advertising on our site helps support our mission. We do not endorse non-Cleveland Clinic products or services. Policy "I take working with patients to make sure we can keep travel in the cards very seriously," Dr. Chaisson says. Patients and their families have a critical role, too, in planning ahead to make travel as safe as possible. A person with pulmonary hypertension has high blood pressure in their lungs, causing their blood vessels to narrow and their heart to work harder. That means they may need medication to widen their lungs' blood vessels, ease the burden on their heart or reduce their symptoms in other ways. In some cases, patients with pulmonary hypertension need oxygen, too.
Most patients, though, can travel safely with these tips from Dr. Chaisson. Tips for patients on medicationsMedicine that treats pulmonary hypertension helps blood vessels relax, expand and pump blood. In people whose pulmonary hypertension isn't severe, oral medications are often enough to control the disease. "There's virtually no problem with these patients traveling on a cruise, by air or even overseas," Dr. Chaisson says. He has a few suggestions to be prepared:
Traveling with an IVPeople whose pulmonary hypertension is more advanced may need intravenous (IV) or subcutaneous (continuously delivered under the skin) medication delivered by a continuous infusion pump. This requires precautions to prevent problems with the pump during travel. If you are on IV or injectable medications for pulmonary hypertension, coordinate your travel with your airline or cruise ship. These companies are used to helping patients with medical needs, Dr. Chaisson says. Keeping a catheter working in a remote or foreign country can be another challenge. "In my experience, the times people get in trouble are when they get hospitalized and the nurse or physician is unfamiliar with pulmonary hypertension," he says. "I have had several instances where patients ran into a problem with the pump or infusion and their medicine was not restarted at the local hospital," he says. To prevent this, keep your doctor's contact information ready so he or she can walk your caregivers through dealing with any problems that might arise with your infusion medication. In addition, tell your doctor before you travel so they can provide you with off-hours contact information and help you plan. As a last resort, contacting your specialty pharmacy in an emergency is an option as nurses at these pharmacies can often assist physicians with questions regarding pulmonary hypertension medications. Bringing oxygen alongPatients with severe pulmonary hypertension may need portable oxygen because they have a weakened heart that has trouble delivering oxygen to the rest of the body. Their travel requires some of the most creativity. Air travel adds another hurdle. A plane at cruising altitude is pressurized at oxygen levels equal to about 8,000 feet above sea level. This means that people who breathe easily at home may struggle in a plane or at destinations at higher altitudes. Since the lung's blood vessels tend to tighten when there isn't as much oxygen in the environment, "It's a little bit of a one-two punch," Dr. Chaisson says. To see if a patient's lungs are strong enough to handle air travel, doctors will often perform an oxygen stress test. Patients' blood oxygen levels will be monitored as they breathe air similar to what they'll experience on a plane or at altitude. If needed, patients may be allowed to take portable oxygen onto the plane. When they are at home, patients who take oxygen therapy use a machine called an oxygen concentrator. These devices, which take oxygen from the air and deliver it to the patient in concentrated form, are available for rent in portable form. Whether you're taking them on the road or in the air, there are a few things to note about these portable concentrators:
In these cases, a doctor will have to certify that you're healthy enough to travel. (Airlines are trying to avoid emergency landings to treat sick flyers.) "In some cases, when a patient just needs too much oxygen and there's no way to get around it, it's just not feasible," Dr. Chaisson says. But usually, with some coordination between your doctor and your airline or cruise ship, pulmonary hypertension doesn't mean you have to stay home.  |
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