Gene Therapy for Melanoma: Progress and Perspectives
FIGURE 1.
Schematic representation of the wild type counterpart of the typically used recombinant viral vectors. (A) Gammaretroviruses and (B) lentiviruses share similar structures, but differ greatly in their genomes and their impact on cellular function. Gag, pro, pol and env genes encode structural proteins of the capsid, protease, reverse transcriptase and envelope proteins, respectively. The additional lentiviral genes perform regulatory functions as well as alter cellular function. (C) The serotype 5 adenovirus has a protein capsid (non-enveloped) and a large, complex genome that encodes critical genes for viral replication (E1a, E1b) as well as structural and functional genes that regulate both viral and cellular activities.
Introduction
Gene therapy, the therapeutic transfer of genetic information to a target cell, continues to be a promising alternative in the fight against cancer. In the case of melanoma, the use of an experimental treatment is justified since this disease is incurable in its advanced stages. Is gene therapy a viable option for the treatment of melanoma patients? In this chapter, we will attempt to answer this question by exploring the intersection between the technology of gene therapy and the biology of melanoma, a point at which opportunities for intervention are revealed.
Gene Therapy for Melanoma: Progress and Perspectives
[1] Cancer Institute of Sao Paulo, University of Sao Paulo School of Medicine, Brazil
[2] University of Sao Paulo, Biomedical Sciences Institute, Brazil
……………….
Analysis Of Vical’s Allovectin-7: Best Results Ever In A Melanoma Phase 3 Trial
check this video
…………….
Vical’s (VICL) Allovectin-7 is a pure immune therapy.(1) Which means it does not directly kill cancer cells, but activates the immune system to do so. Vical will soon announce A-7 phase 3 results in Melanoma, but the mechanism of action is not specific to Melanoma, and can be used in any solid tumor cancer.(2) For this reason, I expect that Allovectin-7 will become one of the best selling cancer drugs of all time.
Allovectin-7 is a substance that is being studied as a gene therapy agent in the treatment of cancer, such as malignant melanoma. It is a plasmid/lipid complex containing the DNA sequences encoding HLA-B7 and ß2 microglobulin – two components of major histocompatibility complex (MHC, class I). It increases the ability of the immune system to recognize cancer cells and kill them.
In 1999, FDA granted Allovectin-7 orphan drug designation for the treatment of invasive and metastatic melanoma.
- Allovectin-7 entry in the public domain NCI Dictionary of Cancer Terms
This article incorporates public domain material from the U.S. National Cancer Institute document “Dictionary of Cancer Terms”.
Vical’s Allovectin-7
Allovectin is a first-class DNA-based immunotherapeutic designed to stimulate both innate and adaptive immune responses in local tumors and distal metastases. The goal is to become a first-line treatment for Stage III and IV melanoma, where it is intended to provide improved efficacy, a better safety profile, and simple outpatient administration.
As last reported, the company is approaching completion of a Phase III registration trial versus chemotherapy in patients with metastatic melanoma. The reporting of end results has had numerous delays, but the results are now expected by Q3.
Outside of Allovectin, Vical has ten clinical trials ongoing, three of those independent and the rest in collaboration. Clearly, Vical is not totally dependent on this immunotherapy though it is the most advanced independent program in the company’s pipeline.
Vical has a market cap of $257M, so clearly a homerun therapy could send the stock soaring.
Pfizer second quarter earnings beat estimates
July 30 2013 | By Márcio Barra
Pfizer reported today their second-quarter profits, beating analysts’ estimates as it prepares to rearrange its business operations. Earnings excluding one-time items were 56 cents a share, compared with the 55 cents average estimated by Bloomberg and Thomson Reuters I/B/E/S. Net income rose more than fourfold to $14.1 billion, or $1.98 a share, from $3.25 billion, or 43 cents last year. Revenue however, fell 7% to $12.97 billion, compared with the $13.03 billion analysts estimated.
View original post 628 more words
Kiran Mazumdar-Shaw, chairman and managing director of Indian biopharma giant Biocon propels company to clock revenue worth $121 mn
Kiran Mazumdar-Shaw, chairman and managing director, Biocon.
Kiran Mazumdar Shaw: She has the odd passion—artwork, horses—but it’s Biocon that really gives her joy
What do our other billionairesses like to splurge on? Kiran’s abiding passion, apart from her work, are horses and paintings—she particularly enjoys collecting the works of Yusuf Arakkal and S.G. Vasudev. Sailoja confesses she loves Louis Vuitton purses and diamond and gold jewellery. “But I haven’t bought any great jewellery for two years now,” she says. Shobhana admits to a weakness for designer watches and bags, as well as light, trendy and stylish fashion jewellery which is not necessarily very expensive. Ekta loves dressing up—but of course her biggest pleasure comes from watching her audience ratings soar.
For most, making billions is not what drives them. Sulajja, who recently sold a 15 per cent stake in her company to Anil Ambani’s Reliance Capital, could be speaking for all of them when she sums up: “Neither me nor my family has been about money. That’s not how we relate to people either. I appreciate that I have certain comforts and don’t have to struggle as much as some for basics, but beyond that we’re just simple hard-working people.”
By Paromita Shastri with Charubala Annuncio, Archana Rai and Madhavi Tata

Kiran Mazumdar-Shaw thinks her training in brewing helped her found biotech company Biocon.
Kiran Mazumdar-Shaw is one of the richest women in India. She is the founder of Biocon, a biotech company and Asia’s largest insulin maker.
But the chairman and managing director attributes her success to her go-getting nature rather than entrepreneurial spirit.
Ms Mazumdar-Shaw originally trained to become a brewer in Australia, before returning to India to follow in her father’s footsteps as a brew-master.
But she struggled to find a job on her return and recalls the industry wasn’t ready for a strong female presence. “The brewing industry is a very, very male dominated industry” she says. “It’s a male bastion.”
Opportunity
She refused to be thwarted. “I really wanted to do something with my life,” she remembers. It was this rebellious streak that inspired her to start her own company, although she admits the opportunity was more by chance.
“This is why I call myself an accidental entrepreneur – because it was an accidental encounter with another entrepreneur… who wanted to set up shop in India and… asked me whether I would be able to partner this venture,” she says.
The chance meeting persuaded Ms Mazumdar-Shaw to launch into the business of developing and making enzymes.
She says she wasn’t daunted by the transition from brewery to biotech. “If you think about brewing, it is biotechnology. And I would say that I was a technologist at heart. So whether I… fermented beer or whether I fermented enzymes, the base technology was the same.”
Female entrepreneurs
She feels this was a canny business move.
“There was no venture funding in India, so it forced me to create a business model that was based on revenues and profits.”
She adds: “That got us into a very different kind of format… to the typical biotech format, which depends largely on VC [venture capitalist] funding.”
But she admits that even as a female entrepreneur she still had to contend with the old issue of gender prejudice.
“Banks were very fearful of lending to a woman because I was considered high risk.”
Her age and the relatively new area of biotechnology didn’t help matters: “I was young, I was twenty-five years old… banks were very nervous about lending to young entrepreneurs because they felt we didn’t have the business experience… and then I had… this strange business called biotechnology which no one understood.”
Kiran Mazumdar-Shaw says her previous experience of failure gave her the resilience to persevere.

“I was determined to make a success of this business because I had failed to be a brew master,” she admits.
“I just kept knocking at people’s doors and I said ‘look you’ve got to… help me’. I did manage to persuade a few people to stand by me and fund me and that’s how I got the business started.”
Bangalore
Ms Mazumdar-Shaw started Biocon in 1978 when Bangalore had yet to become the hub of technology of South India.
She remembers it as a “sleepy old retired city” but says it was an exciting place to start experimenting.
“We were first generation entrepreneurs trying to start high technology businesses… whether it was IT and services, or whether it was my biotech business… that was a time where there was tremendous energy, you know, being unleashed.”
Now she says the transformation of Bangalore into a “vibrant high growth centre” reflects the paradox of India. She believes the contrast between high wealth and extreme poverty – often within a few kilometres of each other – is the result of a failure to follow an inclusive economic agenda.
Social Entrepreneurship
Aside from running Biocon, Kiran Mazumdar-Shaw has also undertaken some social entrepreneurship projects.
One area she’s become involved with is public health. “I am very concerned about the fact that India as a country does not have a national health system, and I am determined to try and influence the government to really build a national health system for the country,” she says.
In the meantime, she has created a network of small clinics to provide some basic health care in rural areas.
BIOCON
- Turnover (2010): Rs 2400 Cr, approx 535 million US dollars
- Number of employees: 5000
- HQ Location: Bangalore
- Year founded: 1978
- Ownership: Listed on BSE & NSE (India)
It’s a part of a “micro health insurance programme” funded largely by her, with small donations from those using it.
Pick yourself up
Kiran Mazumdar-Shaw says self-confidence is an important factor in entrepreneurship.
“A can-do attitude” is essential because obstacles and difficulties are inevitable. “I’ve had many failures in terms of technological… business… and even research failures,” she explains.
“I really believe that entrepreneurship is about being able to face failure, manage failure and succeed after failing.”
The key is to be able to tell the difference between total failure and setbacks which can be overcome.
“I think in my particular case, I’ve seen that failures are not absolute. That you can build and modify those failures to succeed.”
Kiran Mazumdar-Shaw, chairman and managing director, Biocon.
Indian biopharma giant Biocon reported healthy growth of 22 percent for Q1 FY14 riding on the back of an increased geographical footprint in the emerging markets
Bangalore: Indian biopharma giant Biocon reported healthy growth of 22 percent for Q1 FY14. The firm clocked revenues worth $121 million (Rs723 crore), EBITDA of $29.50 million (Rs175 crore); and profit after tax (PAT) of $15.80 million (Rs94 crore).
Read more at: http://www.biospectrumasia.com/biospectrum/news/192549/how-biocon-clock-revenue-worth-usd121-mn#.UfdqX6I3CSo
Biocon’s India-focused branded formulations vertical as well as research services continue to grow at a steady pace

………
check this video
…..
Indian Pharma Market Needs Strong Regulatory Set-up: Kiran Mazumdar-Shaw
Kiran Mazumdar-Shaw, MD, BIOCON
Indian Pharma Market Needs Strong Regulatory Set-up: Kiran Mazumdar-Shaw, MD, BIOCON
Biocon is looking at gaining market share and improving its margins with a greater focus on its product mixes and organizational efficiencies. Biocon Chairman and Managing Director Kiran Mazumdar-Shaw tells Financial Express that the company has outpaced the market, despite various challenges and that the pharmaceutical market needs to have a more robust regulatory set-up. Edited excerpts:
READ ALL AT
http://kiranmazumdarshaw.blogspot.in/2013/07/indian-pharma-market-needs-strong.html
………………
Serum Institute of India acquires rights to TB vaccine
Serum Institute of India acquires rights to TB vaccine
Serum Institute of India, a Pune-based manufacturer of vaccines, is planning on taking a promising vaccine – originally developed in Germany – and introducing it into the clinic. Studies have shown that the new vaccine is more effective and better tolerated than currently available options.
By signing a contract with Hannover-based Vakzine Projekt Management (VPM), Serum has secured the licence to the various patents and technologies related to the…
…..
Natural Remedies for Erectile Dysfunction (ED) & Impotence
WAIT FOR VIDEO TO LOAD
……………………………………
Indian Pharma Market Needs Strong Regulatory Set-up: Kiran Mazumdar-Shaw
DRUG REGULATORY AFFAIRS INTERNATIONAL
Kiran Mazumdar-Shaw, MD, BIOCON
Indian Pharma Market Needs Strong Regulatory Set-up: Kiran Mazumdar-Shaw, MD, BIOCON
Biocon is looking at gaining market share and improving its margins with a greater focus on its product mixes and organizational efficiencies. Biocon Chairman and Managing Director Kiran Mazumdar-Shaw tells Financial Express that the company has outpaced the market, despite various challenges and that the pharmaceutical market needs to have a more robust regulatory set-up. Edited excerpts:
READ ALL AT
http://kiranmazumdarshaw.blogspot.in/2013/07/indian-pharma-market-needs-strong.html
Watermelon Juice Prevents Aching Muscles Food Chemistry: The amino acid L-citrulline found in the fruit could help athletes avoid muscle soreness after a hard workout

India seeks to cancel Roche cancer patent
India may revoke Roche’s breast cancer drug’s patent using section 66 of the Indian Patents Act
India’s health ministry is looking to revoke Roche’s breast cancer drug’s patent in public interest using powers under section 66 of the Indian Patents Act India may revoke Roche’s breast cancer drug’s patent using section 66 of the Indian Patents Act Related Articles Oramed gets Japanese patent for protein delivery Cipla wins patent case against Roche Alchemia cancer drug gets US patent protection Alchemia gets US patent for oncology platform technology New Delhi: India’s health ministry has asked for a cancellation of patent to Roche’s breast cancer medicine Trastuzumab, using a rarest-of-the-rare provision in the Indian Patents Act.
Read more at: http://www.biospectrumasia.com/biospectrum/news/192436/india-seeks-cancel-roche-cancer-patent#.UfXtuaI3CSo