Monday, June 30, 2008

Glutoxim (NVLS) Lead Candidate

Glutoxim is a representative of thiopoietins, a new class of pharmaceuticals possessing a
modulating effect on intracellular processes of thiol metabolism [SH groups containing sulfur and hydrogen atoms]playing an important role in the regulation of genetic and metabolic processes in cells and tissues.
The drug’s mechanism of action consists in regulated escalation of redox state of cells. The new
level of redox systems and of dynamics of phosphorylation of signal-transmitting system key
proteins and transcription factors, primarily of immunocompetent cells, determines the
immunomodulating and systemic cytoprotective effect of the drug. [It keeps the inside of the cell in a reduced state, ready to lose electrons and bind up free radicals]

Glutoxim acts differently on normal cells, where it stimulates proliferation and differentiation [growth and growing into a specialized cell that cannot change again],
and on transformed ones, where it induces apoptosis (genetically programmed cell death). The
main immunophysiological properties of the drug include its high tropism to the cells of central
immunity organs and of the lymphoid tissue system, enhancement of spinal hemopoiesis
(erythropoiesis, lymphopoiesis and granulocyto-monocytopoiesis)[formation of new cells, red blood cells, white blood cells], activation of the phagocytosis [cell eating]
system (including cases of immune deficiency), restoration of neutrophil, monocyte and
lymphocyte count in peripheral blood and of tissue macrophage functional activity. The most
important immunobiochemical effects of the drug include stimulation of cascade mechanisms of
phosphate modification of the signal-transmitting system key proteins, initiation of the cytokine
system, [communication between cells--cytokine are small proteins that elicit very specific cellular reactions] including endogenous synthesis of interleukine 1, interleukine 6, tumour necrosis factor, interferons, erythropoietin, and reproduction of interleukine 2 effects by inducing expression of its receptors.

NVLT closed down 3 cents in today's trading to 0.50 cents per share in relatively normal trading volume.

Note: NVLT today announced that it was issued U.S. Pat. No. 7,371,411 by the U.S. Patent and Trademark Office extending the composition and method of use claims relating to NOV-002, Novelos’ lead compound in an ongoing pivotal Phase 3 trial for non-small cell lung cancer under a Special Protocol Assessment (SPA) and Fast Track. NOV-002 has also demonstrated positive results in Phase 2 trials for other oncology indications.

Novelos has a commanding intellectual property position around its oxidized glutathione-based product platform, which currently includes 6 issued U.S. patents, 2 European patents (that have gone national) and 1 Japanese patent. Overall, Novelos filed more than thirty patent applications worldwide. Together, these will provide broad and long-lasting coverage, up to at least 2019, encompassing composition of matter, method of use and manufacturing for Novelos’ compounds.

Sunday, June 29, 2008

I'm having some down time..

Our mascot, UGA VI died yesterday. It's a sad time and it's right before the season kicks off.

RIP UGA.

more NVLT tomorrow.

Update: NVLT

I'm in the process of legging the ground work of NVLT's product pipeline. I can get more in depth tomorrow when I can gain access to scientific journals at work.

Some Background First:
The Company was incorporated in June 1996 as AVAM International, Inc. In October 1998, Novelos Therapeutics, Inc., a newly incorporated entity, merged into AVAM, and the name of AVAM was changed to Novelos Therapeutics, Inc. In 2005, the Company completed a two-step reverse merger with Common Horizons, Inc., and its wholly-owned subsidiary Nove Acquisition, Inc. Following the merger, the surviving company was Novelos Therapeutics, Inc. The Company is a biopharmaceutical company commercializing oxidized glutathione-based compounds for the treatment of cancer and hepatitis. NOV-002, its lead compound, is currently in Phase 3 development for lung cancer under a Special Protocol Assessment and Fast Track. NOV-002 is also in Phase 2 development for chemotherapy-resistant ovarian cancer and early-stage breast cancer, and is also being developed for acute radiation injury. NOV-205, the Company's second compound, is in Phase 1b development for chronic hepatitis C non-responders. Both compounds have completed clinical trials in humans and have been approved for use in Russia where they were originally developed.

Ok, so what does glutathione based compounds mean?
IN the body, glutathione acts much like a scavenger, finding and neutralizing free oxygen species, such as hydrogen peroxide. It's a small molecule produced in every cell of the body. It has three amino acids. It originates from three primary amino acids in the body: glutamate, cysteine and glycine. Glutathione is actually a tripeptide made up the amino acids gamma-glutamic acid, cysteine, and glycine. The primary biological function of glutathione is to act as a non-enzymatic reducing agent to help keep cysteine thiol side chains in a reduced state on the surface of proteins. Glutathione is also used to prevent oxidative stress in most cells and helps to trap free radicals that can damage DNA and RNA. There is a direct correlation with the speed of aging and the reduction of glutathione concentrations in intracellular fluids. As individuals grow older, glutathione levels drop, and the ability to detoxify free radicals decreases.

NOV-002: (from Novelos website: www.novelos.com)
NOV-002, the lead compound, acts as a chemoprotectant and a chemopotentiator. NOV-002 was approved in Russia where it is marketed by PharmaBAM under the trade name Glutoxim®. NOV-002 has already been administered to over 10,000 patients, including clinical studies of 390 patients across many tumor types, demonstrating clinical efficacy and excellent safety. In one controlled, randomized Russian Phase 2 trial, NOV-002 in combination with cisplatin-based chemotherapy increased the one-year survival of advanced NSCLC patients from 17% to 63% (p < href="http://www.glutoxim.ru/" target="_blank">Glutoxim®. NOV-002 has already been administered to over 10,000 patients, including clinical studies of 390 patients across many tumor types, demonstrating clinical efficacy and excellent safety. In one controlled, randomized Russian Phase 2 trial, NOV-002 in combination with

Post is getting long. Repost with more info shortly. Reading the mechanism of action now.