Squalamine lactate

PLYMOUTH MEETING, Pa., June 19 /PRNewswire-FirstCall/ -- Genaera Corporation today announced that it will present a poster on trodusquemine (MSI-1436), its novel anti-obesity compound, during the American Diabetes Association (ADA) 67th Scientific Sessions, June 22 to 25 in Chicago. The abstract, # 1801-P, is titled, "Trodusquemine is a Multiple Pathway Inhibitor that Causes Differential Weight Loss, Reduces Adiposity, and Improves Plasma Insulin and Leptin Levels." The poster will be available from Saturday, June 23 through Monday, June 25 during the times the General Poster Session is open to conference attendees. Representatives from Genaera will be available to discuss the poster on Sunday, June 24 from 6:15 p.m. to 7:30 p.m. (CT) and on Monday, June 25 from 12:00 p.m. to 2:00 p.m. (CT). For more information online, please visit: uID=1000 About Trodusquemine (MSI-1436) Trodusquemine is a centrally and peripherally-acting appetite suppressant and the first highly selective inhibitor of protein tyrosine phosphatase 1B (PTP-1B). PTP-1B is central to controlling the function of both the leptin and insulin pathways. By inhibiting PTP-1B, MSI-1436 is expected to decrease appetite and normalize blood sugar. Trodusquemine has produced consistent, sustainable weight loss in a variety of animal models and appears to overcome metabolic readjustment, which often limits sustained weight loss during caloric restriction. In addition, trodusquemine has shown the ability to reverse co-morbidities associated with obesity such as abnormal glucose metabolism and cholesterol elevation. About Genaera Genaera Corporation is focused on advancing the science and treatment of metabolic diseases. The Company has significant market opportunities with a first-in-class molecule, trodusquemine (or MSI-1436), that has the potential to redefine the treatment paradigm for obesity and type 2 diabetes and is presently in a Phase 1 trial in obesity. In addition, Genaera has a value-driven, fully out-licensed partnership with MedImmune for a second core program that is presently undergoing Phase 2 clinical testing in asthma. Genaera is committed to directing resources to its core program and the aggressive clinical development of its key assets to build stockholder value. . This announcement contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties, known and unknown. Forward-looking statements reflect management's current views and are based on certain expectations and assumptions. Such statements include, among others, statements regarding these preliminary results, clinical development plans and prospects for Genaera's programs including trodusquemine (MSI-1436), the IL-9 antibody program, LOMUCIN(TM), or squalamine. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "believe," "continue," "develop," "expect," "plan" and "potential" or other words of similar meaning. Genaera's actual results and performance could differ materially from those currently anticipated and expressed in these and other forward-looking statements as a result of a number of risk factors, including, but not limited to: Genaera's history of operating losses since inception and its need for additional funds to operate its business; the costs, delays and uncertainties inherent in scientific research, drug development, clinical trials and the regulatory approval process; the risk that clinical trials for Genaera's product candidates, including trodusquemine (MSI-1436), the IL-9 antibody program, LOMUCIN(TM), or squalamine may be delayed or may not be successful; the risk that Genaera may not obtain regulatory approval for its products, whether due to adequacy of the development program, the conduct of the clinical trials, changing regulatory requirements, different methods of evaluating and interpreting data, regulatory interpretations of clinical risk and benefit, or otherwise; Genaera's reliance on its collaborators, in connection with the development and commercialization of Genaera's product candidates; market acceptance of Genaera's products, if regulatory approval is achieved; competition; general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industry; and the other risks and uncertainties discussed in this announcement and in Genaera's filings with the U.S. Securities and Exchange Commission, all of which are available from the Commission in its EDGAR database at as well as other sources. You are encouraged to read these reports. Given the uncertainties affecting development stage pharmaceutical companies, you are cautioned not to place undue reliance on any such forward-looking statements, any of which may turn out to be wrong due to inaccurate assumptions, unknown risks, uncertainties or other factors. Genaera does not intend (and it is not obligated) to publicly update, revise or correct these forward-looking statements or the risk factors that may relate thereto. Genaera Corporation CONTACT: investor relations, Genaera Corporation, +1-610-941-5675; ormedia, Susan Neath of Porter Novelli Life Sciences, +1-619-849-6007,sneath@pnlifesciences.com Web site:

I spent most of last week at the JP Morgan healthcare conference--it was a great meeting; the mood was definitely upbeat, and rooms were packed even for some not so interesting companies. There were a number of companies that had impressive presentations and I will detail some of these in future alerts. One company that is particularly interesting is Atherogenics (AGIX). I recently bought some of this for my own account in the mid $17 range. I will write about this company for subscribers shortly, but in essence, it is a play on the results of an upcoming Phase II study using an oral antioxidant agent to reverse coronary artery disease. Results will be available later this year. The market is huge and a recent short-term Phase II trial showed a significant increase in lumen volume--almost as good as the Esperion data using an IV infusion of an HDL molecule. The upcoming second Phase II results will be a binary event for AGIX. I have recently sent out an alert to subscribers about Genaera and I thought I would update BioSpace readers as to my current thinking. I think what I said still holds true even though the stock just went up over 10% today. GENR is a small cap company (market cap $217 million as of 1/20/04) with a lead antiangiogenesis product in trials for cancer and the wet form of age related macular degeneration (AMD). This company even in an expensive market still looks relatively cheap. AMD is a big market with no really good therapy. Visudyne is currently approved for a subset of patients but as a therapy it is not a spectacular success. Two competing products are in late stage trials--Macugen from Pfizer/ Eyetech and Lucentis from Genentech. The recent one year data from Macugen is also less than spectacular and may have to do with dosing problems and the fact that the drug is just not that good. Lucentis may be a better drug but the one year data is not in yet. Both drugs have to be given by direct injection into the back of the eye. The problems with that approach include infections and bleeding. I haven’t talked to any retinal specialist who is excited about doing multiple vitreous injections. This approach might be more viable if you could get by with one or two injections but AMD is a chronic disease and will need chronic therapy. The initial Phase I/II data from GENR was from a single institution in Mexico. The trial was run by a very well respected retinal specialist using all modern endpoints. What impressed me was not only the early results but the efficacy at 4 months. Patients were reading better, retinal angiograms looked better and the drug appears safe. The data looks as good as the early trials for both Lucentis and Macugen. The really important aspect is that the GENR drug, squalamine, can be given by an injection into an arm vein (peripheral vein). This eliminates all the potential complications of direct injections into the eye. You also get the benefit of treating both eyes with one injection. Safety should not be a big issue especially short-term since the company is using the same drug in cancer trials at much higher doses with no complications. The stock has not traded up much probably because of a lack of news flow and because they are perceived as being so much further behind in the development cycle when compared to Lucentis and Macugen. I think that is short-sighted. The company is negotiating with the FDA on a Phase II protocol and trials could start by mid-year. I think there is also a possibility they could do a lucrative partnership this year. Based on the kind of deal Eyetech did with Pfizer around the drug Macugen, you would have to say this company is very undervalued. Management is smart and I think up to the job. The company also has other assets. Their interleukin-9 (IL-9) patent estate has value and their partner MedImmune has filed an IND for a Phase I study in asthma using a humanized IL-9 antibody (PDLI license). GENR will receive a modest early milestone and if the drug is approved high single digit to low double digit royalties. There is good genetic and animal data (IL-9 knockout) to suggest that this cytokine is an important growth factor for mast cells and plays an important role in asthma and bronchospasm. Squalamine also has upside in the cancer market and is currently in trials for lung cancer (NSCLC) and metastatic prostate cancer. The company also has technology that may be important in the area of cystic fibrosis (CF) but development will depend on further funding from the CF foundation. There may some interest from big Pharma if patents issue on the protein and gene target of LOMUCIN (their CF drug). This target could be of interest for other indications as well. The company’s financials show only a modest amount of cash--as of the last report on 9/30, they had about $8 million cash and they raised another $8 million in November of ’03. This could be enough to get them through a Phase II trial and to a partnership. However, there will likely be more rounds and dilution. I like this company because of the importance of the AMD market and the lack of any satisfactory therapies. Also, big pharma has shown a willingness to make huge deals in this area. As a matter of disclosure, I want all readers to know that I own many of the stocks I write about in my personal account and always maintain a long position. I am not a stock broker or a registered investment adviser. I also write about some of these stocks in alerts for BioSpace, which can be found at Biotech Insight is a web-based newsletter published and archived at Alerts and newsletters are sent electronically to subscribers. The following is further disclosure: Dr. Garren is an advisor to two funds investing in biotechnology. I recommend many of these same stocks to the investment funds mentioned above. It should be noted that certain funds go both long and short. The information in this column under no circumstances serves as a recommendation to buy or sell stocks. Please also see the disclosure about Biotech Insight archived on BioSpace. Ronald Garren, M.D. Click here to subscribe to the Biotech Insight Newsletter DISCLAIMER Information transmitted via BioSpace has been provided by publishers of the “Biotech Insight” Investment Newsletter. It is not guaranteed as to completeness or accuracy by BioSpace, the Biotech Insight publishers, or any person. Such Information is neither an offer to sell nor a solicitation to buy the securities of any company. Opinions expressed are subject to change without notice. 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