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Personalized Tumor Vaccine Hits Phase 2
bevacizumab
str ref———-http://www.kidneycancerinstitute.com/Bevacizumab.html
Northwestern Medicine recently joined a landmark clinical trial to investigate if a vaccine made from a patient’s own brain tumor is effective in slowing tumor progression and extending survival. The randomized phase 2 trial will study how well giving the study vaccine with or without Avastin (bevacizumab) works in treating patients with recurrent glioblastoma multiforme (GBM).
Bevacizumab
(Avastin, Genentech Inc.- Year approved:2009)
Avastin (or bevacizumab to the scientific community) is a humanised monoclonal antibody that is directed against all biologically active forms of VEGF. Antibodies are molecules that are typically a normal part of the human immune system. An antibody is meant to bind to a very specific target which is then typically destroyed and removed by the body. Avastin is an antibody that binds VEGF and acts to block its action.
Bevacizumab was one of the first antiangiogenic agents to demonstrate activity against metastatic kidney cancer. Bevacizumab is administered intravenously every two weeks. On July 31, 2009, the FDA granted approval for the use of Avastin in combination with interferon-? for the treatment of patients with metastatic renal cell carcinoma. The approval was based on results published in the journal Lancet in 2007. In this double-blind phase III trial 649 patients with metastatic kidney cancer who had undergone nephrectomy, were randomized to either bevacizumab plus Interferon-? or placebo plus Interferon-? as a first-line treatment. Median progression-free survival of patients was significantly improved in those receiving the combination treatment including Bevacizumab and Interferon-? compared to the control group (10.2 vs 5.4 months). Response rates were also significantly improved in the Bevacizumab and Interferon-? groups (31% vs 13%). The most common severe (grade 3) toxicity was fatigue: 12% in the bevacizumab and IFN arm versus 8% in the control arm.
A second multicenter phase III trial which was performed in 2008 and which was conducted in the United States and Canada, was nearly identical in design with the exception that it lacked a placebo element and did not require prior nephrectomy. In this second study, the average progression-free survival was 8.5 months in patients receiving The combination of Bevacizumab and Interferon-? compared to 5.2 months for patients receiving Interferon-? therapy alone. The overall response rate was in favour of the combination group (25.5% vs 13.1%). However, both studies failed to show any significant difference regarding overall survival between the combination of Bevacizumab and Interferon-? versus Interferon-? alone (18.3 vs 17.4 months).
Bevacizumab (trade name Avastin, Genentech/Roche) is an angiogenesis inhibitor, a drug that slows the growth of new blood vessels. It is licensed to treat various cancers, including colorectal, lung, breast (outside the USA), glioblastoma (USA only), kidney and ovarian.
Bevacizumab is a humanized monoclonal antibody that inhibits vascular endothelial growth factor A (VEGF-A). VEGF-A is a chemical signal that stimulates angiogenesis in a variety of diseases, especially in cancer. Bevacizumab was the first clinically availableangiogenesis inhibitor in the United States.
Bevacizumab was approved by the U.S. Food and Drug Administration (FDA) for certainmetastatic cancers. It received its first approval in 2004, for combination use with standardchemotherapy for metastatic colon cancer.It has since been approved for use in certain lung cancers, renal cancers, and glioblastoma multiforme of the brain.
At one point bevacizumab was approved for breast cancer by the FDA, but the approval was revoked on 18 November 2011. The approval for breast cancer was revoked because, although there was evidence that it slowed progression of metastatic breast cancer, there was no evidence that it extended life or improved quality of life, and it caused adverse effects including severe high blood pressure and hemorrhaging. In 2008, the FDA gave bevacizumab provisional approval for metastatic breast cancer, subject to further studies. The FDA’s advisory panel had recommended against approval. In July 2010, after new studies failed to show a significant benefit, the FDA’s advisory panel recommended against the indication for advanced breast cancer. Genentech requested a hearing, which was granted in June 2011. The FDA ruled to withdraw the breast cancer indication in November 2011. FDA approval is required for Genentech to market a drug for that indication. Doctors may sometimes prescribe it for that indication, although insurance companies are less likely to pay for it. The drug remains approved for breast cancer use in other countries including Australia.
Clinical trials are underway for many other indications including ovarian cancer, pediatric osteosarcoma, and certain non-malignant eye diseases. In the curative setting (adjuvant therapy), clinical studies are underway in breast cancer and lung cancer.
FDA Approves Investigational MS Trial
The stem cell research division of the Tisch MS Research Center of New York announced that the U.S. Food and Drug Administration (FDA) approved autologous, mesenchymal stem cell-derived neural progenitor cells (MSC-NPs) as an Investigational New Drug (IND) for an open label, phase 1 clinical trial in the treatment of multiple sclerosis.
FDA approves GlaxoSmithKline’s Tivicay, for the treatment of AIDS
August 14, 2013 | By Márcio Barra
GSK announced yesterday that the FDA has given green light for ViiV Healthcare’s Tivicay(dolutegravir) 50-mg tablets, an integrase inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 in adults and children aged 12 years and older weighing at least 40 kg (approx. 88 lbs). It can be used to treat infected adults who have been treated with other drugs or are new to treatment.
Integrase inhibitors are a new class of antiretroviral agents that block HIV replication in the body by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). In short, they stop the virus from entering cells.
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Biocon Launches Psoriasis Drug In India; To File IND Application With US FDA This Fiscal
India’s Biocon on Saturday launched ALZUMAb, a novel biologic for the treatment of psoriasis, in India. Sreeja/IB Times
KIRAN MAZUMDAR SHAW, CHAIRMAN BIOCON
itolizumab is other name
| Jan 13: Biocon has received marketing approval in India. The company plans to file an investigational new drug application with the FDA seeking authorization for further human trials which will support regualtory approval in the US. | |
| Biocon is to seek pre-IND advice from the US FDA . | |
| On completing proof-of-concept PIII trials, Biocon will seek a licensing partner for itolizumab. The company has stated it expects to initiate licensing discussions during the 2010/2011 financial year |
Bangalore, India-based Biocon (NSE:BIOCON) announced Saturday the launch of its first biologic drug for the treatment of chronic psoriasis in India, and said it would file an investigational new drug, or IND, application with the U.S. Food and Drug Administration, or FDA, by the end of this fiscal year.
read all at
The drug, Alzumab, is the second biologic — a medicine created through a biological process and not through a chemical process — launched by the company, and is expected to serve about 1 percent to 2 percent of India’s population estimated to suffer from the ailment.
Itolizumab (INN, trade name Alzumab) is a ‘first in class’ humanized IgG1 monoclonal antibody developed by Biocon. It selectively targets CD6, a pan T cell marker involved in co-stimulation, adhesion and maturation of T cells. Itolizumab, by binding to CD6, down regulates T cell activation, causes reduction in synthesis of pro-inflammatory cytokines and possibly plays an important role by reducing T cell infiltration at sites of inflammation. A double blind, placebo controlled, phase III treat –Plaq study of itolizumab successfully met the pre-specified primary end-point of significant improvement in PASI-75 (Psoriasis Area and Severity Index) score after 12 weeks of treatment in patients with moderate to severe psoriasis compared to placebo.[2] Biocon has received marketing authorization for the drug from the Drugs Controller General of India (DCGI).
J and J gets green light for front-line Velcade in EU
Bortezomib
Johnson & Johnson’s multiple myeloma treatment Velcade has been cleared as a first-line therapy in the EU, boosting the number of patients eligible for treatment with the drug.
The European Commission gave the go-ahead for Velcade (bortezomib) as induction therapy in combination with dexamethasone and thalidomide in previously-untreated multiple myeloma patients who are eligible for high-dose chemotherapy and a stem cell transplant.
http://www.pharmatimes.com/Article/13-08-09/J_J_gets_green_light_for_front-line_Velcade_in_EU.aspx
Bortezomib bound to the core particle in a yeast proteasome. The bortezomib molecule is in the center colored by atom type (boron = pink, carbon = cyan, nitrogen = blue, oxygen = red), surrounded by the local protein surface. The blue patch is catalyticthreonine residue whose activity is blocked by the presence of bortezomib.
Bortezomib (INN, originally codenamed PS-341; marketed as Velcade by Millennium Pharmaceuticals and Bortecad by Cadila Healthcare) is the first therapeutic proteasome inhibitor to be tested in humans. It is approved in the U.S. for treating relapsedmultiple myeloma and mantle cell lymphoma. In multiple myeloma, complete clinical responses have been obtained in patients with otherwise refractory or rapidly advancing disease.
Bortezomib was originally synthesized in 1995 (MG-341) at a company called Myogenics, which soon changed its name to ProScript. After promising preclinical results, the drug (PS-341) was tested in a small Phase I clinical trial on patients with multiple myeloma cancer. ProScript ran out of money and was bought by Leukosite in May 1999. Leukosite in turn was bought byMillennium Pharmaceuticals in October 1999. At this point in time, the project had low priority amongst other projects at the company. This changed significantly when one of the first volunteers to receive the drug in the clinical trial achieved a complete response and were still alive four years later. At the time this was a remarkable result. Later clinical experimentation indicates the possibility of a complete response in 15% of patients in a similar condition, when treated with bortezomib.
In May 2003, seven years after the initial synthesis, bortezomib (Velcade) was approved in the United States by the Food and Drug Administration (FDA) for use in multiple myeloma, based on the results from the SUMMIT Phase II trial.
Another commercially available bortezomib product – Bortenat (Natco Pharma, India), reportedly contains substantially more active entity than declared, potentially and even more resulting in increase toxicity. Moreover, Bortenat has some other chemical and formulation deviations from the registered ethic product Velcade (Millennium Pharmaceuticals and Janssen-Cilag), with unclear clinical impact
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In my practice this product
Ixchelsis, a start-up company that has come out of Pfizer’s former R D site at Sandwich, UK, is progressing a treatment for premature ejaculation boosted by the backing of Eli Lilly.
Lilly, through its venture fund set up with TVM Capital Life Science, has
invested in Ixchelsis, made up of former Pfizer scientists and headed by Gary
Muirhead. The company is based on an oxytocin receptor antagonist called IX-01
originally discovered at Sandwich which the investors say “has the potential to
be the best-in-class pharmacological approach for the treatment of
PE”.
Ixchelsis, which is based at the Sandwich site, now called Discovery
Park, will collaborate with the autonomous early phase virtual drug discovery
arm of Lilly, known as Chorus. Dr Muirhead told PharmaTimes that the
TVM model will fund through to the agreed exit point, which is completion of
proof-of-concept and this requires about $14 million.
read all at
http://www.pharmatimes.com/Article/13-08-08/Lilly_backs_Ixchelsis_a_start-up_born_at_Pfizer.aspx
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British drugmaker GlaxoSmithKline (GSK) has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for its cervical cancer vaccine, Cervarix [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant].
The application in the EU is to allow administration of the vaccine in a two dosing schedule (0, 6 months) in 9-14 year old girls.
Intended to serve as an alternative dosing schedule, the two-dose schedule will help prevent premalignant genital (cervical, vulvar and vaginal) lesions and cervical cancer causally related to certain oncogenic Human Papillomavirus (HPV) types. It does not seek to replace the three-dose schedule.
read all at
Cervarix is a vaccine against certain types of cancer-causing human papillomavirus (HPV).
Cervarix is designed to prevent infection from HPV types 16 and 18, that cause about 70% of cervical cancer cases. These types also cause most HPV-induced genital and head and neck cancers. Additionally, some cross-reactive protection against virus strains 45 and 31 were shown in clinical trials. Cervarix also contains AS04, a proprietary adjuvant that has been found to boost the immune system response for a longer period of time.
Cervarix is manufactured by GlaxoSmithKline. An alternative product, from Merck & Co., is known as Gardasil.
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New Drug Approvals 