Dow Jones 10542.21 -44.02 7:41 am PST, November 8, 2005  NASDAQ 2174.09 -4.15 For info, visit access.smallcapnetwork.com S & P 500 1218.15 -4.66 Change your subscription status here Russell 2000 655.87 -5.37 VOLUME 05: ISSUE 84  Feature: Novelos - FDA Meeting Soon, Radiation and the Shriners. Two recent substantive events further bolster our contention that Novelos Therapeutics (OTCBB: NVLT) deserves a place in the smallcap biotech sector of your portfolio. First, NVLT recently announced that it had been granted a meeting with the FDA on December 2nd. At that meeting, the company will review its positive Phase1/2 Nov-002 data for the treatment of non-small cell lung cancer (NSCLC). NVLT could get the green light later in December to work with the FDA to structure a Phase 3 Special Protocol Assessment (SPA). If agreeable, NVLT would plan to have the SPA in place by the end of Q1 2006. The company's plan would then be to begin the NOV-002 Phase 3 NSCLC study by Q3 2006. This news is important as it puts NVLT well ahead of its original clinical study timetable. The company had originally hoped for such a meeting with the FDA later in 2006.  Simply put, an SPA is a set of strict Phase 3 study parameters agreed upon by the filing company and the FDA. Once the company satisfactorily meets the endpoint and guidelines of the contract, the FDA will approve the drug. Followers of Novelos will note that the daily trading volumes have become more robust of late. We suggested accumulation in our October 11th piece as the shares had weakened to $2.35and that a bounce back up to $2.60 would be the best eventuality for the shares. The bounce came to pass, consolidation followed and the shares moved nicely to $3.20, Monday. The next resistance level is $3.75 and a breach of that level would be very bullish for the shares. Considering NVLT just came public in June of 2005, the progress of both the share price and rising trading volumes is extremely encouraging. Traders and long-term investors should accumulate shares of Novelos here and on any dips for what we believe will be superior gains over the next 12 months. Second? NOV-002, Radiation Sickness and the Shriners One of the attributes of NOV-002 that has interested me for a while is Novelos's claim of the efficacy of the compound to treat cases of Acute Radiation Sickness. Today, (release below) NVLT announced a collaboration with the world-renowned Shriners Hospital for Children to confirm the findings previously obtained in Russian studies. The company hopes that confirming these findings will enhance its planned proposal submission to the Department of Health and Human Services (DHHS), which it expects to make in 2006.  From the release: In previous preclinical experiments conducted in Russia, groups of mice and rats were exposed to lethal doses of radiation. The treatment of animals with NOV-002 (after irradiation) resulted in a two- to three-fold increase in thirty day survival compared to the irradiated but untreated control animals. NOV-002 treated animals did not experience severe neutropenia (loss of white blood cells used for fighting off infections) and demonstrated significantly higher bone marrow cell counts than the control (bone marrow is the source of white blood cells). I would encourage you to read the enclosed release carefully for more detail of the potential effectiveness on NOV-002 on this extremely nasty condition. Needless to say, in the dangerous world in which we live, the need for this type of therapy has become necessary and the potential market is vast and growing, both domestically and worldwide. The importance of both of these announcements should not be discounted. The determination with which Novelos is executing its clinical study timetable is exactly what smallcap biotech investors should expect from the management of these types of formative stage companies. Promises and vision are fine, but the road to commercialization has to be aggressively pursued.  It's apparent that NVLT is well on its way down that path. As well, multiple uses of biotech technology further demonstrate the potential for the prospects of the company. NOV-002 as a cancer therapy, a treatment for radiation sickness and perhaps other applications should increase investor interest and further diversify NVLT eventual revenue streams.  As we have oft-said, the uniqueness of NVLT is that a number of its technologies are either already proven or at the very least have significant clinical data courtesy of its Russian experience to bolster its US regulatory applications. That fact alone should give investors more than the usual confidence that the company has a better chance than the standard biotech to quickly move its products through clinical development and into commercial use.   Press Release Novelos Therapeutics in Collaboration with Shriners Hospitals to Confirm Positive Data in Acute Radiation Injury; Company Plans to Compete for U.S. Government Procurement in 2006 Nov 8, 2005 8:00:00 AM Copyright Business Wire 2005 NEWTON, Mass.--(BUSINESS WIRE)--Nov. 8, 2005--Novelos Therapeutics, Inc. (OTCBB: NVLT), a biotechnology company focusing on oxidized glutathione for use in treating cancer and hepatitis, announced today collaboration with Shriners Hospitals for Children to confirm the positive findings in the therapy of acute radiation injury obtained in Russian experiments. Novelos plans to submit a proposal to the Department of Health and Human Services (DHHS) in 2006 for treatment of patients with NOV-002 after acute exposure to lethal radiation. In previous preclinical experiments conducted in Russia, groups of mice and rats were exposed to lethal doses of radiation. The treatment of animals with NOV-002 (after irradiation) resulted in a two- to three-fold increase in thirty day survival compared to the irradiated but untreated control animals. NOV-002 treated animals did not experience severe neutropenia (loss of white blood cells used for fighting off infections) and demonstrated significantly higher bone marrow cell counts than the control (bone marrow is the source of white blood cells). "In addition to confirming and extending these findings, our research collaboration with Shriners Hospital, a leading medical research institution, aims to more precisely identify the cellular and molecular actions of NOV-002 that underlie its ability to combat acute radiation injury. NOV-002 is a safe, clinically proven product that has the potential to reduce the development of neutropenia, increase bone marrow cells and improve chances of survival when administered shortly after acute exposure to radiation", said Christopher J. Pazoles, Ph.D., Vice President of Research & Development of Novelos Therapeutics. "Confirmation of these findings at the Shriners' laboratory would make Novelos' proposal to DHHS more competitive", added Harry S. Palmin, President and CEO of Novelos. In December 2004, Novelos Therapeutics responded to DHHS' Request for Information for therapeutics to treat neutropenia and thrombocytopenia (loss of platelets responsible for blood clotting) associated with Acute Radiation Syndrome (ARS). DHHS is currently soliciting public comments on its draft Request for Proposal (RFP) for this therapeutic goal. DHHS' current draft procurement plans are for up to 100,000 treatment courses of medical countermeasures, with additional 100,000 courses anticipated to be procured at a later date. Multiple awards may be made with a 20,000 course minimum procurement. Novelos expects DHHS to issue a formal RFP in 2006, at which time Novelos plans to submit a proposal. About Novelos Therapeutics, Inc. Novelos Therapeutics, Inc. (OTCBB: NVLT) was established in 1996 to commercialize two promising oxidized glutathione-based compounds, NOV-002 and NOV-205, for the treatment of cancer and hepatitis. Both compounds have completed clinical trials in humans and have been approved for use in the Russian Federation where they were developed. NOV-002, marketed in Russia by an unrelated entity under the trade name GLUTOXIM(R), has been administered to over 5,000 patients, demonstrating clinical efficacy and excellent safety data. The U.S.-based Phase 1/2 clinical study of NOV-002 in combination with chemotherapy for lung cancer has been completed, with positive results. A Phase 2B/3 study is expected to commence in 2006. The Company plans to file an IND with the FDA for NOV-205 as a mono-therapy for hepatitis C in 2005. About Shriners Hospitals for Children Shriners Hospitals for Children is a network of pediatric specialty hospitals, founded by the Shrine of North America, where children under the age of 18 receive excellent medical care absolutely free of charge. There are 22 Shriners Hospitals dedicated to treating children with orthopaedic problems, severe burns and spinal cord injury problems. For over 40 years Shriners Hospitals have conducted research to discover new knowledge that improves the quality of care and quality of life of children and their families. Shriners Hospitals are located throughout North America. These "Centers of Excellence" serve as major referral centers for children with complex orthopedic and burn problems. For more information about Shriners Hospitals for Children, please visit its website at www.shrinershq.org. About Novelos' Products NOV-002, the lead compound, is being developed to treat non-small cell lung cancer (NSCLC). NOV-002 is designed to act as a cytoprotectant and an immunomodulator. When used in combination with chemotherapy, NOV-002 increased the one-year survival rate from 17% to 63% in a Russian study, a result that also represents an 80% improvement above the U.S. 35% current standard of care. A U.S.-based Phase 1/2 clinical study has been completed. NOV-002 treated patients demonstrated improved objective tumor response (defined as greater than 50% tumor shrinkage) and higher tolerance of chemotherapy versus the control group. NOV-002 was well tolerated, thus adding to the compound's already extensive safety data base. NOV-002 is also being developed to treat refractory (that is, not responsive to chemotherapy) ovarian cancer. Two additional clinical indications, radiation protection and psoriasis, will also be investigated for NOV-002. NOV-205 is being developed to treat chronic hepatitis C in the U.S. NOV-205 is designed to act as a hepatoprotective agent with immunomodulating and antiviral activity. In Russian clinical studies, when used as mono-therapy for one month in hepatitis B and for two months in hepatitis C, NOV-205 has been shown to greatly reduce or eliminate viral loads and to vastly improve liver function relative to existing drugs on the market. This news release contains forward-looking statements. Such statements are valid only as of today, and we disclaim any obligation to update this information. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our pharmaceutical collaborators' ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. Source: Novelos Therapeutics, Inc. ---- Company Contact: Novelos Therapeutics Inc. Harry S. Palmin - President and CEO 617-244-1616 ext. 11 hpalmin@novelos.com or Investor Relations: H.C. Wainwright & Co Inc. Stephen Lichaw - Vice President 212-856-5706 slichaw@hcwainwright.com    We Value Your Feedback Got comments, questions or suggestions? 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