Low oxygen levels drive cancer growth

f hypoxia, or low oxygen levels in cells, is proven to be a key driver of certain types of cancer, treatment plans for curing the malignant growth can change in significant ways, said Ying Xu, professor of bioinformatics and computational biology at Georgia University’s Franklin College of Arts and Sciences.

The research team analysed samples of messenger RNA data, also called transcriptomic data, from seven different cancer types in a publicly available database.

They found that long-term lack of oxygen in cells may be a key driver of cancer growth, the Journal of Molecular Cell Biology reports.

Previous studies had linked low oxygen levels in cells as a contributing factor in cancer development, but not as the driving force for cancer growth.

High cancer rates worldwide cannot be explained by chance genetic mutations alone, Xu said, according to a Georgia statement.

He added that bioinformatics, which melds biology and computational science, has allowed researchers to see cancer in a new light.

“Cancer drugs try to get to the root, at the molecular level, of a particular mutation, but the cancer often bypasses it,” Xu said.

“So we think that possibly, genetic mutations may not be the main driver of cancer.”

The researchers analysed data downloaded from the Stanford Microarray database via a software programme to detect abnormal gene expression patterns in seven cancers: breast, kidney, liver, lung, ovary, pancreatic and stomach.

Xu relied on the gene HIF1A as a biomarker of the amount of molecular oxygen in a cell. All seven cancers showed increasing amounts of HIF1A, indicating decreasing oxygen levels in the cancer cells.

Low oxygen levels in a cell interrupt the activity of oxidative phosphorylation, a term for the highly efficient way that cells normally use to convert food to energy.

Low oxygen levels engender the process of creating new blood vessels. They provide fresh oxygen, thus improving oxygen levels in the cell and tumour and slowing the cancer growth – but only temporarily.

“When a cancer cell gets more food, it grows; this makes the tumour biomass bigger and even more hypoxic. In turn, the energy-conversion efficiency goes further down, making the cells even hungrier and triggering the cells to get more food from blood circulation, creating a vicious cycle. This could be a key driver of cancer,” Xu said.

FDA issues final rule on sterility testing of biological products

The U.S. Food and Drug Administration issued its final rule on sterility testing, amending the requirements for most licensed biological products. The action follows a retrospective review of agency regulations to promote improvement and innovation and is in response to Executive Order 13563 that is designed to improve regulation and regulatory review.
The FDA recognizes the role innovation plays in bringing safe and effective products to market in a timely and cost-efficient manner. This action reflects the agency’s efforts to review and, as necessary, update biologics regulations, to keep pace with technological developments and to boost regulatory science.
The amendments to the sterility testing rule will provide manufacturers of biological products the flexibility, as appropriate, to keep pace with technological and scientific advances.

FDA issued a final rule on sterility testing on May 3, 2012, that amends the requirements for most licensed biological products and aims to provide manufacturers with the flexibility, as appropriate, to keep pace with technological and scientific advances. The rule is in response to President Obama’s Executive Order 13563 which called for improving regulation and regulatory review.

Specifically, the rule revises sterility requirements under Title 21 of the Code of Federal Regulations (CFR), subchapter F, parts 600 through 680 as follows:

  1. “Eliminates specified sterility test methods, culture media formulae (or formulation), and culture media test requirements
  2. Eliminates specified membrane filtration procedure requirements for certain products
  3. Eliminates specified sterility test requirements for most bulk material
  4. Modifies the repeat sterility test requirements, so that repeat tests will occur only once for each lot
  5. Replaces the storage and maintenance requirements for cultures of test organisms used to determine the “growth-promoting qualities” of culture media with validation requirements specifying that any sterility test used is able to consistently detect the presence of viable contaminating microorganisms, and with verification of “growth-promoting properties” or microorganism-detection capabilities of test and test components
  6. Replaces the sample size or amount requirement with a requirement that the sample be appropriate to the material being tested
  7. Replaces the Interpretation of test results section under § 610.12(c) with a requirement that manufacturers establish, implement, and follow written procedures for sterility testing that describe, at a minimum, the test method used, the method of sampling, and the written specifications for acceptance or rejection of each lot
  8. Simplifies and clarifies the Exceptions section under § 610.12(h)
  9. Identifies the Director of CDER as one of the two Center directors authorized to grant an exemption under the exception provision at § 610.12(h)(2). In the proposed rule, the Center for Devices and Radiological Health was erroneously identified in this exception, instead of the Center for Drug Evaluation and Research
  10. Revises the definition of the term “sterility” under § 600.3(q).
  11. Eliminates certain exceptions for allergenic products related to sterility testing under § 680.3(c).”

Companies will not have long to implement the changes as the rule takes effect June 4, 2012. The proposed rule received several comments from industry and the final rule includes the agency’s response to those recommendations. Overall, FDA “recognizes the role innovation plays in bringing safe and effective products to market in a timely and cost-efficient manner,” according to an FDA announcement of the rule. “This action reflects the agency’s efforts to review and, as necessary, update biologics regulations, to keep pace with technological developments and to boost regulatory science.”

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Cancer drugs to cost less, Cipla slashes prices !!!

Cipla, has announced a massive reduction of up to 76 per cent in its cancer drug prices after the Indian government recently lifted a patent license.

Following the move,

  • The price of Cipla’s generic kidney cancer drug, Sorafenib, will be available at Rs 6,840 a month from the earlier Rs 27,950.
  • The lung cancer drug Gestinib price has been cut down by 60 per cent to just over Rs 4000, instead of earlier Rs 10,200.
  • Temozolamide, a very effective brain tumour treatment drug has come down to Rs 5000 from the original Rs 20,250.