Safety and Therapeutic Profile of a GnRH-Based Vaccine Candidate Directed to Prostate Cancer. A 10-Year Follow-Up of Patients Vaccinated With Heberprovac.

Heberprovac is a GnRH based vaccine candidate containing 2.4 mg of the GnRHm1-TT peptide as the main active principle; 245 μg of the very small size proteoliposomes adjuvant (VSSP); and 350 μL of Montanide ISA 51 VG oil adjuvant. The aim of this study was to assess the safety and tolerance of the Heberprovac in advanced prostate cancer patients as well as its capacity to induce anti-GnRH antibodies, the subsequent effects on serum levels of testosterone and PSA and the patient overall survival.

Pharmacokinetics comparison of two pegylated interferon alfa formulations in healthy volunteers.

Background: Several countries have used pegylation technology to improve the pharmacokinetic properties of essential drugs. Recently, a novel interferon alfa-2b protein conjugated to four-branched 12 kDa polyethylene glycol molecules was developed jointly between Cuba and Brazil. The aim of this study was to compare the pharmacokinetic properties of BIP48 (pegylated interferon alfa-2b from Bio-Manguinhos/Fiocruz, Brazil) to those of PEGASYS® (commercially available pegylated interferon alfa-2a from Roche Pharmaceutical).

Transvenous Onyx embolization of a subependymal deep arteriovenous malformation with a single drainage vein: technical note.

Cerebral arteriovenous malformations (AVMs) are uncommon. Treatment options include embolization, radiosurgery and surgery, separately or combined, the final goal being complete occlusion of the malformation. We describe the case of a symptomatic small subependymal AVM with a single deep drainage vein previously treated unsuccessfully by radiosurgery and transarterial embolization.

Direct transforaminal Onyx embolization of intracranial dural arteriovenous fistulas: technical note and report of five cases.

Intracranial dural arteriovenous fistulas with retrograde leptomeningeal or cortical drainage are considered aggressive. Conventional treatment in these cases is possible surgically or with endovascular arterial injections of Onyx or cyanoacrylate, but there are still some cases where distal navigation is not possible due to tortuosity of the arterial feeders. We present five cases of direct transforaminal Onyx embolization where endovascular distal navigation could not be achieved.

Transvenous Onyx embolization of a subependymal deep arteriovenous malformation with a single drainage vein: technical note.

Cerebral arteriovenous malformations (AVMs) are uncommon. Treatment options include embolization, radiosurgery and surgery, separately or combined, the final goal being complete occlusion of the malformation. We describe the case of a symptomatic small subependymal AVM with a single deep drainage vein previously treated unsuccessfully by radiosurgery and transarterial embolization.

Percutaneous onyx embolization of cervical paragangliomas.

Cervical paragangliomas are a group of vascular neoplasms arising from the extraadrenal neuroendocrine system. The present report describes a series of six cases of cervical paragangliomas successfully and safely embolized preoperatively by means of ethylene vinyl alcohol copolymer delivered by percutaneous needle punctures without the need for balloon protection. Although the results are promising, further studies are needed to confirm the superiority of this method versus other embolization techniques and embolic agents.

Phase I clinical trial of the (131)I-labeled anticarcinoembryonic antigen CIGB-M3 multivalent antibody fragment.

Center for Genetic Engineering and Biotechnology (CIGB)-M3 is a trivalent recombinant single-chain Fv antibody fragment specific for carcinoembryonic antigen (CEA). Preclinical studies with radiolabeled CIGB-M3 have showed that the antibody fragment accumulates in human colon tumor xenografts growing in nude mice. A Phase I clinical trial was carried out to determine safety, biodistribution, and pharmacokinetics of the radiolabeled CIGB-M3 in two groups of patients with CEA+ colorectal cancers.

Immunogenicity and safety assessment of the Cuban recombinant hepatitis B vaccine in healthy adults.

Manufactures of biotechnological/biological products (including vaccines) frequently make changes to manufacturing processes of products both during development and after approval. In our case, a non-inferiority bridging study was carried out to demonstrate that changes in the production plant facilities of Cuban recombinant hepatitis B vaccine, Heberbiovac HB, did not affect the safety and immunogenicity of the vaccine. This controlled, randomized, doubled-blinded trial included 501 volunteers, aged between 20 and 64, who were given three doses of vaccine (20 microg HBsAg/mL) at month 0, 1, and 2.