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Helix picks BioVectra to manufacture new lung cancer bulk dr

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http://www.in-pharmatechnologist.com/ne ... f-the-lung

10/01/2007 - Helix BioPharma and BioVectra have signed a deal for the manufacture of Helix’s new lung cancer drug for clinical trials – a move that strengthens the already existing relationship between the two Canadian firms.

Helix's new product, L-DOS47, is expected to be a potential treatment for adenocarcinoma of the lung, the most common form of cancer in the world today.

“The signing of this agreement builds upon previous manufacturing work through which fundamental cGMP processing parameters for L-DOS47 have been developed,” said John Docherty, Helix's vice president of corporate development.

“BioVectra is a natural choice for our clinical manufacturing programme requirements because in addition to their high calibre capabilities in the cGMP production of biopharmaceuticals, they are also one of the largest North American producers of the urease substance at the heart of our L-DOS47 drug product."

The manufacturing of Helix's new drug candidate will be conducted in BioVectra's cGMP API facility in Charlottetown, Prince Edward Island, Canada.

BioVectra has specialised experience in development-scale fermentation, isolation and purification of bioactive substances from natural biomass sources for pharmaceutical applications, and synthetic modification of these substances.

The firm claims that it is this cross-functional capability to conduct several project components in coordination, working under cGMPs, which is unique as a custom manufacturing partner for drug developers.

All terms of the deal between the two firms remain undisclosed, however, Heather Stewart, a spokesperson for BioVectra, told OutSourcing-Pharma.com that the deal represents “an important piece of business” for its cGMP custom manufacturing business.

“[This deal] is exemplary of the type of service [bioVectra] can provide to its exclusive clients seeking to advance their drug product through clinical investigation,” added Stewart.

She said that the company currently provides pharmaceutical and biopharmaceutical companies with either custom manufacturing services of both development-phase or commercial active pharmaceutical ingredients (APIs) and intermediates, or, the provision of bioprocess and MPEG reagents toward therapeutic manufacturing.

Adenocarcinoma is the most common type of lung cancer, making up 30 to 40 per cent of all cases. Currently used methods to treat the condition include radiation and chemotherapy.

However there are newer agents called tyrosine kinase inhibitors that are given as pills as there is a suggestion that adenocarcinomas may be more sensitive to these agents. They are part of a newer type of chemotherapy emerging called targeted therapy; the main product available is Tarceva, a pill used to treat certain cases of lung cancer that has fewer side effects than traditional treatments.

According to Ontario-based Helix, its new product combines the company's proprietary DOS47 new drug candidate with a highly specific single domain antibody to form a potential new targeted drug product for the treatment of the disease.

L-DOS47 is thought to function by leveraging a natural process in the body called the urea cycle to produce an anti-cancer effect.

“It is based upon a naturally occurring enzyme called urease that essentially reverses the urea cycle by breaking down urea into metabolites that include ammonia and hydroxyl ions,” said the firm.

By doing so at the site of cancerous tissues in the body, L-DOS47 is believed to modify the microenvironmental conditions of lung cancer cells in way that leads to their deaths.

In addition, the new drug is believed to stimulate an increase in the pH of the microenvironment surrounding the cancerous cells, effectively reversing the acidic extra-cellular conditions that are known to be necessary for cancer cell survival.

Furthermore, the local production of ammonia at the site of cancerous tissues is thought to readily diffuse into the cancer cells to exert a potent cytotoxic effect by interfering with their critical metabolic functions.

Helix said it intends to complete the remaining preclinical animal testing studies of L-DOS47 this year, while finalising its clinical manufacturing activities.

The company said it is focused on its path toward pursuing the necessary regulatory authorisations thereafter to conduct a Phase I clinical trial of L-DOS47 in patients with adenocarcinoma of the lung.

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