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Physician’s Financial News

Merger Announcement Is the Latest Chapter in Compelling ImClone Story

Over the past several weeks, the oncology sector of the biotechnology industry has been buzzing about the on-again, off-again merger between Bristol-Myers Squibb (BMS) and ImClone Systems (NASDAQ: IMCL). The saga being spun by the two companies has taken numerous twists and turns over the past several news cycles and may or may not remain unresolved by press time.

Background

On July 31st, in yet another illustration of the growing appetite of big pharmaceutical companies for smaller biotechs that boast successful drugs, BMS made an unsolicited $60-per-share offer, equivalent in value to roughly $4.5 billion, for the remainder of ImClone that it does not already own (currently BMS holds a 17% minority stake in ImClone, acquired in 2001). The offer for the remaining 83% of the company would allow BMS to purchase the remainder of ImClone, as well as rights to the cancer drug Erbitux (cetuximab) and five products in the ImClone development pipeline. The cash offer represents a premium of about 30% over ImClone’s closing share price on the day the offer was made. Investors, however, apparently believe the sale price of ImClone could go even higher, bidding up the company’s shares by almost 38% on the day following the offer. Indeed, since the first batch of BMS-related rumors hit the Street, ImClone shares have become an increasingly hot property. In a recent period spanning less than one month (from late June to late July 2008), the per-share price of the equity jumped from the high $30s to the mid $60s.

Moving Forward

An ImClone spokesperson said that the company is in the process of studying the BMS offer, which was delivered by letter to the chairman of ImClone, Carl C. Icahn. For nearly seven years, BMS and ImClone have had a relationship centered on Erbitux. BMS and ImClone co-promote Erbitux in the United States and Canada, while Germany’s Merck KGaA co-markets the drug with BMS in Japan and holds the rights to the product in other countries.

Mr. Icahn, known as an activist investor, is the chairman of ImClone’s board of directors and the biggest single ImClone shareholder with the exception of BMS. Mr. Icahn had established a 13% stake in the company and stands to pocket $390 million if he sells his 11.67 million shares at BMS’s offer price.

Oncology & Biotech News

When contacted by about the potential transaction, both ImClone and BMS officials were tight-lipped. In other periodicals, James M. Cornelius, chairman and chief executive, BMS, has cited the company’s previous problems with the Securities and Exchange Commission as reasons for his muted level of communication.

Mr. Cornelius did say in a recent statement that BMS and ImClone were natural partners. Several analysts have lauded the proposed merger as a smart move. As of press time, however, the deal was far from sealed. ImClone is on record as stating that the $60-per-share takeover bid from BMS may be too low. Mr. Icahn told his colleagues on the ImClone board that he opposed BMS’s offer because he believes it “greatly undervalues the company.” As the days of negotiations between the two companies drag into weeks and months, even the once optimistic Mr. Cornelius has stated that he is “not absolutely confident” that the acquisition will move forward as planned.

Numerous industry experts have suggested that ImClone can fetch much more than what BMS has offered. Analysts have speculated that ImClone might ultimately sell for more than $65 a share. The final price may be even higher if the companies factor in rising sales of Erbitux. In addition, “Buying ImClone makes BMS a more sellable company itself. It strengthens the company’s overall cancer franchise by having full control of Erbitux in the U.S. and by gaining access to ImClone’s drugs in development,” argued Tim Anderson, an analyst at Sanford C. Bernstein & Co., New York City, in a note to Sanford C. Bernstein investors that was disclosed to the media. In an interview with Bloomberg television, Jeffrey Kraws, chief executive officer, Crystal Research Associates, New York City, explained, “Any one of the largecap pharmaceutical companies could step up (with a competing offer).”

Also, the possibility exists that ImClone might add significant variables to the purchasing equation. An ImClone spokesperson said that its board of directors has been discussing the possibility of splitting the company in two, separating its Erbitux cancer treatment from its drugdevelopment pipeline businesses. The ImClone spokesperson said that the company believes its pipeline business “may be extremely valuable and significantly increase stockholder value as a separate business.” In what may prove to be a further hurdle to the ImClone—BMS marriage, Mr. Icahn has expressed dismay that one of the directors on ImClone’s board was a BMS designee who was privy to discussions about potentially separating the company. As a result, ImClone said its board is reviewing whether BMS had access to confidential information about the company and its pipeline.

A final issue that the two organizations must resolve prior to any merger-related progress concerns a controversy over an ImClone-developed antibody that has been characterized as an upgraded, next-generation version of Erbitux. Should this antibody obtain FDA approval, reported an ImClone spokesperson, the potential product “might have a significant competitive effect on Erbitux,” and BMS may have no rights to market that product. ImClone claims to own the complete rights to the next-generation Erbitux compound, which carries high expectations but will not be seen on the market until well into the next decade. This interpretation is disputed by BMS. The disagreement revolves around whether the drug, known as IMC-11F8, was derived in any way from the current Erbitux and if its development can be viewed as a “competing product,” as defined by a 2001 agreement between the companies. If either of the above circumstances is true, BMS is entitled to rights to the drug.

Owing to the confusion, the battle over IMC-11F8 could end up in front of an arbitrator and may take years to resolve, something BMS can avoid by buying ImClone. This may mean raising its initial offer, a move that Wall Street seems to expect (if the recent upward trend of ImClone stock is any indication). At any rate, industry insiders assert that the resolution of the next-generation Erbitux dispute between ImClone and BMS could influence billions of dollars in sales over the next decade, ImClone’s total value, the actions of other possible suitors, and whether ImClone attempts to spin off its pipeline.

It is relevant to note that ImClone has earned the attention of oncology professionals and the oncology marketplace, not merely because of the BMS acquisition soap opera it has been embroiled in of late, but also because of various news-making achievements the company has attained in its own right. The merger does not represent the end-all, be-all of ImClone’s future: Should BMS’s $60-per-share offer remain unconsummated, the BMS-ImClone contract to market Erbitux would survive. The agreements of ImClone’s global Erbitux partners—BMS and German drug maker Merck KGaA—will be unaffected by any potential merger or lack thereof. “Whoever will own ImClone in the future doesn’t impact our existing licensing agreement,” stated Merck spokesman Dr. Gangolf Schrimpf.

Additionally, the company continues to make robust research- and development-related strides. For example, ImClone’s flagship drug Erbitux (to date, ImClone’s sole FDA-approved product, currently approved as a therapy for patients with metastatic colorectal cancer or cancer of the head and neck), is undergoing increased testing for a gene that may indicate Erbitux’s enhanced effectiveness in colorectal cancer, enabling the drug to attain expanded colorectal treatment indications in the future. A company spokesperson cited this development as “positive for [Erbitux’s] long-term future,” adding that ImClone expects to file with the FDA for approval to use Erbitux in treating lung cancer. The lung cancer filing is preliminarily slated to take place at some point in the fourth quarter of 2008. Future guidance data furnished by ImClone projects 2008 global Erbitux sales of $1.7 billion, up 31% from $1.3 billion in 2007. By 2011, Erbitux sales could exceed $3.1 billion.

In addition to lead product Erbitux, ImClone’s research efforts have yielded a robust oncology-focused pipeline (Figure on previous page) that includes five antibodies in various stages of development. Besides Erbitux, ImClone has five experimental drugs in development for cancer. Three of the medicines are in the second of three stages of testing needed to win regulatory approval, while the other two are in initial-stage human trials

Ziopharm Data Affirms Safety and Efficacy of Early- Stage Product Candidate

Ziopharm, New York City, presented data from two phase I studies of indibulin, the company’s new, orally administered, synthetic tubulin targeted agent, at the recent American Association for Cancer Research (AACR) Centennial Conference on Translational Cancer Medicine in Monterey, California.

A total of 34 patients have been treated in the two phase I studies and safety, tolerability, and early activity have been evaluated from varying doses and dose schedules. Study patients presented with sarcomas and a variety of carcinomas, including pancreatic, thyroid, ovarian, prostate and lung cancers. To date, 24 patients have received at least two cycles of therapy and are evaluable for efficacy using RECIST criteria. Of these, prolonged stable disease of greater than four months has been observed in 11 patients, with three of these patients reaching eight or more months to date. In addition, early PET scans have demonstrated one complete reduction in uptake, six with partial reduction in uptake, and four with increased uptake.

Tumor responses measured by PET scan are generally referred to as metabolic responses, and usually correlate with treatment responses in cancer. The most common study drug—related toxicities reported were mild-to-moderate fatigue, nausea, diarrhea and anorexia. Unlike studies of other microtubule targeting agents, no neurotoxicity and minimal bone marrow suppression were observed.

“Early data suggest that indibulin is clearly active in a number of cancers, and maintains a toxicity profile that distinguishes it from other tubulin binding agents such as the taxanes and vinca alkaloids,” said Sant P. Chawla, MD, director, Sarcoma Oncology Center, Santa Monica, and a lead investigator of the study. “Notably, the common and serious side effects typically associated with this class of therapy have not been observed. We look forward to seeing indibulin developed in tumor-specific studies.”

Indibulin is a novel synthetic antimitotic agent that binds to tubulin, destabilizes microtubule polymerization, arrests tumor cell growth at the G2/M phase and inhibits cell mobility and metastasis. Microtubules are well-established targets for anticancer drug development and tubulin-binding drugs such as taxanes and vinca alkaloids are currently widely used to treat cancer. According to a Ziopharm spokesperson, indibulin is orally available, lacks neurotoxicity and has efficacy in taxane-refractory preclinical models.

According to the company, further details on the two trials will be made available as developments occur on the federal government’s clinical trials Website (at www.clinicaltrials.gov).

YM Biosciences Posts Positive Phase II Data for Potential Colorectal Drug Therapy

YM Biosciences, Mississauga, Canada, announced preliminary results obtained from its YMB1000- 015 trial, an open-label, phase II study of nimotuzumab in patients with irinotecan-refractory, metastatic colorectal cancer (mCRC). The data are based on 58 evaluable patients of the 61 enrolled in the trial. The trial was conducted at 10 centers across Canada and consisted of treatment with 400 mg of nimotuzumab weekly plus irinotecan (Camptosar) in patients refractory to irinotecan alone, with patients remaining on nimotuzumab until disease progression.

The prospective primary endpoint of YMB1000-015 was objective tumor response rate (RR) with secondary endpoints that include overall survival (OS), the rate and duration of stable disease, and progression free survival (PFS). The RR was 3.4% while the disease control rate reported was 50%, consisting of 27 patients with stable disease and two patients with partial response as determined using RECIST criteria. Median PFS was 12 weeks. The OS (based on Kaplan-Meier criteria) in the evaluable patients was 9.3 months.

Tissue samples from 17 patients were available for KRAS analysis. Approximately 30% of the patients had mutated kRAS. (A PFS of 12 wk was observed in patients with the mutation and 18 wk in patients with wild type.) Although only a relatively small number of samples were analyzed, according to investigators, results were in line with expectations.

“These preliminary data are released upon our being advised that the trial has now reached the point at which more than 50% of the patients have died. The OS and disease control rate (DCR) for patients receiving nimotuzumab compare well with published results in similar patient populations treated with cetuximab, a currently marketed epidermal growth factor receptor (EGFR) monoclonal antibody. Nimotuzumab also continues to display a safety profile unequalled in its class. This low incidence of toxicity with nimotuzumab may be related to differences reported in its interaction with EGFRs compared with other EGFR-targeting antibodies,” stated Dr. Paul Keane, director of medical affairs, YM BioSciences.

Amil Shah, MD, medical oncologist and chair, Gastrointestinal Tumor Group at the BC Cancer Agency and principal investigator for the trial, added, “The median overall survival of 9.3 months and disease control rate of 50% together with the exceptional safety profile of nimotuzumab support continuing development of nimotuzumab in patients with colorectal cancer.”

The reported OS and DCR in YMB1000-015 are similar to those observed in the other trials; however, in YMB1000-015 they are accompanied by an important advantage in the toxicity profile of nimotuzumab. Nimotuzumab was administered without premedication, and, in contrast to cetuximab (Erbitux), no infusion reactions were observed. No subjects discontinued treatment or required dose reductions because of nimotuzumab-related adverse events.

According to David Allan, chairman and CEO of YM BioSciences, although the results reported herein support further development of nimotuzumab in the metastatic colorectal cancer setting and colorectal cancer is high on the list of indications that YM Biosciences and its licensees plan to develop, immediate plans for the company entail concentrating on indications where nimotuzumab can complete pivotal trials in the shortest time within its available resources. The company, disclosed Mr. Allan, intends to file for registration trials in 2008 for patients with non— small cell lung cancer and for those with brain metastases “because of compelling observations in phase II trials in those indications and because they require shorter development times than colorectal trials would require.”

Roche Courts a Reticent Genentech

Continuing the recent trend of big drug-makers seeking to acquire biotechnology companies that are already their partners in some capacity (i.e., see previous article covering BMS’s attempted acquisition of ImClone), Roche has offered to buy the remaining 44% of its longtime biotechnology partner, South San Francisco—based Genentech, for $43.7 billion. According to Business Week, big drug makers, in their constant search for innovative products, have been buying biotechs at a record pace: Nearly $70 billion worth of deals have been inked this year, almost double last year’s tally.

Roche’s initial takeover bid was $43.7 billion, which works out to $89 per share for the 44% of Genentech that Roche does not yet own. Genentech rejected Roche’s initial offer (as Genentech shares closed 11% higher than the offer on the day it was made). However, the biotechnology company said it was open to further talks and negotiations. Responding in a formal statement to the Roche proposal, a committee of Genentech directors that were specifically convened to consider the potential acquisition, stated that the “unsolicited and unexpected” offer “substantially undervalues the company.” A Genentech spokesman said the company had no comment beyond the release. Releasing its own statement, Roche asserted that it “continues to believe its proposal is fair and generous and has no further comment at this point.”

Genentech’s response means that negotiations between the company and Roche will begin shortly, with a likely resolution in one to two months. It is widely expected by industry watchers that Roche will come back with a higher counter-offer.

The opening offer has been criticized by investors who say Roche is trying to get a bargain. In fact, shortly after Roche made its bid public, a Genentech investor filed a lawsuit in Delaware Chancery Court over the proposed buyout, saying the bid is unfair and inadequate.

Although Roche’s offer would have paid shareholders an 8.8% premium on Genentech’s closing price on the day the deal was proposed, the general analyst consensus views Roche’s proposed purchase price as a low-ball offer. Wall Street traders have been betting that Roche can be pressured to raise its bid. Genentech’s shares have risen 15.7% since Roche made its offer public. Investors have said it could take a bid as high as $125 a share to purchase the company. Genentech’s top U.S. product, Avastin (bevacizumab), is being tested against 30 different malignancies. Positive data expected next year on its use as a first-choice drug against colon cancer could add $2.2 billion to its $3.4 billion in annual sales.

Under an agreement between Genentech and the Swiss drug maker, a sale or acquisition of the company must be approved by holders of a majority of shares other than Roche, according to a Genentech regulatory filing. Though Genentech’s minority owners have rights, Roche’s majority stake makes any other bidder unlikely.

In the meantime, Genentech is moving to “address any employee concerns’’ about a possible takeover by implementing an employee-retention program. The retention plan is designed to allow the company to retain top talent and avoid the ‘brain drain’ that can often accompany a corporate takeover as employees jump ship because of fears of job insecurity and/ or lost independence.

Wall Street, anticipating a continuation of proposed deals of this nature, has reacted accordingly: In the wake of Roche-Genentech and BMS-ImClone, shares of Onyx Pharmaceuticals, which developed a cancer drug with Bayer, closed up 10%; shares of Amylin Pharmaceuticals, which co-developed a diabetes drug with Eli Lilly, climbed nearly 15%. The Roche offer comes during a period in which traditional pharmaceutical companies buying smaller biotechnology players to replenish their pipelines is become increasingly more common. Recent deals of note, to cite just a few, include Takeda Pharmaceutical’s acquisition of Millennium Pharmaceuticals for $8.8 billion and GlaxoSmith-Kline’s purchase of Sirtris Pharmaceuticals for $720 million.

According to industry experts, Roche is making its move now because it wants to control 100% of Genentech’s commercial operations—especially blockbuster oncology products such as Avastin, Rituxan (rituximab) and Herceptin (trastuzumab)— before it has to renegotiate a new marketing agreement in 2015. In addition, the current weakness in the U.S. dollar works to Roche’s advantage. Furthermore, Genentech has one of the deepest research and development pipelines in the industry, which should help Roche grow in the future and maintain its strong position in what is becoming an increasingly competitive marketplace.

The Swiss drug maker stated that the proposed takeover would cut costs and boost its profits from Genentech medicines. Control of the remainder of Genentech would give Roche more income from both Avastin and Herceptin and ownership of compounds being developed by the innovative biotech company.

Roche, which previously had owned Genentech outright, spun it back into the public market with a 1999 share offering that allowed other investors to gain a minority interest.

Bayer Moves to Solidify Oncology Market Position

German pharmaceutical giant Bayer AG has completed a number of transactions aimed at strengthening and streamlining its competitive position in the oncology sector. The company recently announced the expansion of its oncology pipeline through the purchase of a preclinical oncology program from Nycomed, a pharmaceutical company headquartered in Switzerland.

The agreement comprises two potential drug candidates and an extensive set of back-up compounds targeting a kinase critical for growth and survival of cancer cells. Bayer Schering Pharma will assume full development and commercialization rights of the program.

Nycomed will receive an initial reward and payments upon completion of agreed preclinical and regulatory milestones. Overall compensations could exceed $100 million.

“The acquisition of this promising program strengthens Bayer Schering Pharma’s oncology pipeline as it is complementary to existing inhouse approaches,” said Andreas Busch, member of the Board of Management of Bayer Schering Pharma AG, responsible for Global Drug Discovery. “The deal underpins our commitment to oncology research and our long-term aspiration to provide new treatment options for patients suffering from cancer,” continued Mr. Busch.

In addition, Bayer recently announced that it has signed an exclusive in-licensing agreement with Sonus Pharmaceuticals, Bothell, Washington, for development of a family of compounds known as caspase activators. This family of compounds, presently in preclinical research, consists of small molecules that have been identified by researchers as activators of programmed cell death. (Unlike normal cells, many tumor cell types have lost the ability to undergo the normal process of programmed cell death, known as apoptosis. By activating the caspase pathway, tumor cells can be triggered to undergo apoptosis resulting in cell death.) Since the caspase activators likely play essential roles in apoptosis, the caspase activators offer the potential for the development of therapies in the treatment of various cancers.

The lead compound has demonstrated antitumor activity in a range of preclinical animal tumor models, including taxane-resistant tumors, following both intravenous and oral administration. The partnership is expected to yield compounds in phase I clinical development within 12 to 18 months.

Under terms of the agreement, Sonus was granted exclusive rights to develop two core compounds for all prophylactic and therapeutic uses in humans. Additionally, Sonus was granted rights to all other non-core compounds covered under the patents for use in oncology. Bayer retained rights to develop biological conjugates of the molecules (excluding the two core compounds).

In addition, Bayer will receive an upfront license fee of $450,000, milestone payments, and royalties on sales of any compounds successfully commercialized upon FDA approval. Specific financial terms on milestone payments and royalties were not disclosed.

On May 28, 2008, Sonus Pharmaceuticals, Inc. and OncoGenex Technologies Inc., Bothell, Washington, jointly announced the signing of a definitive agreement to merge. The combined company will operate as OncoGenex Pharmaceuticals, Inc. The proposed merger is expected to be completed in the third quarter of 2008.

Amgen’s Nplate Approved; ITP Treatment Options Expanded

Amgen Inc. has obtained FDA approval for Nplate (romiplostim), touted by the company to be the first and only platelet producer for the treatment of thrombocytopenia in splenectomized and non-splenectomized adults with chronic immune thrombocytopenic purpura (ITP). Nplate, the first FDA-approved peptibody protein, works by raising and sustaining platelet counts.

The FDA approval of Nplate was based on efficacy and safety results from two pivotal phase III studies of adult patients with chronic ITP, including both splenectomized and non-splenectomized patients. The overall response rate for Nplate was 83% (n = 69/83) of treated splenectomized and non-splenectomized patients, and platelet counts were raised and sustained in these six-month studies. Additionally, patients treated with Nplate were able to reduce or discontinue their use of concomitant ITP medications and emergency medications (i.e., corticosteroids, IVIG, Win-Rho, Anti-D therapy).

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Specifically, in the phase III studies, non-splenectomized patients had an 88% (n = 36/41, <.001) overall platelet response and splenectomized patients had a 79% (n = 33/42, <.001) overall platelet response rate. Combined data from both trials show clinically relevant bleeding events were significantly reduced by half in patients treated with Nplate compared with placebo (15% vs. 34%, = .018). Amgen continues to study the long-term efficacy and safety of Nplate (for which, according to the company, there is more than three years of follow-up safety and efficacy data).

“Until now, patients suffering from chronic ITP have had limited available treatment options, many of which are often unsuitable for longterm use due to side effects and tolerability issues,” stated David J. Kuter, MD, Chief of Hematology, Massachusetts General Hospital, Boston. “Nplate represents the first long-term treatment for adult chronic ITP patients, providing a new treatment approach for this chronic disease.”

In addition to improved clinical benefits, described in the FDA labeling, Amgen believes Nplate offers patients a positive net health benefit with fewer hospitalizations from bleeding events, as well as reduced need for emergency medications (IVIG and Win-Rho). Amgen expects the total costs of care for chronic ITP patients managed with Nplate to be less than or comparable to the total costs of care with standard treatment regimens.

Amgen also announced it will launch the Nplate NEXUS (Network of EXperts Understanding and Supporting Nplate and Patients) Program, a multifaceted program designed to provide comprehensive access, support and education for chronic ITP patients, their caregivers and health care providers. The Nplate NEXUS Program is part of the Risk Evaluation and Mitigation Strategy (REMS) developed by Amgen in partnership with the FDA to assure safe use of Nplate while minimizing risk. The program will facilitate appropriate use of Nplate, provide patient support through education and resources, and help with ongoing follow up through safety data collection.

“Amgen is committed to advancing the discovery and development of new therapies for grievous illnesses where there is unmet medical need,” explained Roger M. Perlmutter, MD, PhD, executive vice president, Research and Development, Amgen. “The FDA approval of Nplate is the result of more than 15 years of research and represents an important biotechnology milestone as it is the first FDA-approved peptibody protein, an innovative platform for delivering targeted therapies.”

Chronic ITP is a serious autoimmune disorder characterized by low platelet counts in the blood (thrombocytopenia), which can lead to serious bleeding events. Recognized as an orphan disease, chronic ITP affects an estimated 60,000 adult patients in the United States and is considered an unmet need by the FDA.

Biovest Tapped to Join International Research Initiative

Biovest International, Inc., a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc., Tampa, Florida, has been designated as one of the charter members of the Joint U.S.—Norway Cancer Research Program, an investigational collaboration among a select group of pharmaceutical and biotechnology companies and research organizations. The vision of the project, according to a recent Biovest press release, is “to improve and extend the lives of cancer patients [using] world-class cancer diagnostics and treatments.”

According to participants, the research program will focus its efforts and pursue cancer research with both the National Cancer Institute and the U.S. military health care system. It has been reported that medical research officials at the U.S. Department of Defense believe the U.S.— Norway cancer research collaboration can leverage the current efforts of the U.S. Navy Cancer Vaccine Program, based at the U.S. Naval Health Research Center in San Diego. The Center was established to develop and deliver operational biomedical research solutions and to create vaccines and other cancer-related therapies for various types of cancer, including breast cancer, ovarian cancer, and colon cancer.

Biovest’s current research and development focus has been cited as a primary factor in attracting the attention of the research program and for the company’s inclusion in the project. It is likely that U.S—Norway Research Project developers took notice of Biovest’s current efforts to commercialize BiovaxID, a personalized biologic therapeutic cancer vaccine now completing phase III clinical trials to treat non-Hodgkin lymphoma. The development and manufacture of AutovaxID, Biovest’s patented technology enabling cancer vaccines to be developed much more rapidly and cost-effectively than current systems, was also cited as a key asset.

Commenting on Biovest’s role, chairman and CEO, Steven Arikian, MD, stated, “We are extremely proud to be one of the original members of this prestigious alliance of innovators in the field of cancer research. As we are advancing BiovaxID to potentially become the first ever anticancer vaccine approved in the U.S. and/or Europe, we expect to be a key contributor based on our level of expertise in the field of cancer vaccine immunotherapy. Additionally, we are highly proficient in the cost-efficient, commercial-scale manufacture of such personalized vaccines through the use of our proprietary biomanufacturing system, AutovaxID, which we envision will be utilized to produce many kinds of drugs and vaccines targeting many types of cancers.”

Participants in the joint program are working with the staff of the U.S. Senate Committee on Health, Education, Labor and Pensions and with the Delta Regional Authority, an independent federal agency, to arrange scientific presentations by U.S. and Norwegian cancer research collaborators with the National Cancer Institute.

The genesis of the Joint U.S.—Norway Cancer Research Program dates back to the work of Robert Elliott, MD, founder and current president of the American Mastology Association and the developer of the first patented breast cancer vaccine in the United States. For years, Dr. Elliott has given his own “Look to Norway” series of lectures in the United States, including at the National Cancer Institute, and abroad. Dr. Elliott and others believe that Norwegian researchers have been pioneers in the field of immunotherapy and that American cancer researchers can make great advances in the fight against cancer by collaborating with their Norwegian counterparts.

The joint program was established under a formal Memorandum of Understanding. In addition to Biovest International, charter members include the University Hospital of North Norway and Norwegian companies Lytix BioPharma AS and Lauras AS, both key members of the Oslo Cancer Cluster. Other U.S. participants are the MeritCare Roger Maris Cancer Center in Fargo, North Dakota, and OBM Therapies, LLC.

Hepatitis Treatment May Prevent Melanoma Recurrence

Dutch researchers have discovered that Schering-Plough Corporation’s hepatitis C drug Pegintron (pegylated interferon alfa- 2b) helps stop the return of melanoma after surgery. According to results from a recently released phase III trial, participants who received regular injections of Pegintron following surgery to remove their tumors had an 18% reduced risk of cancer recurrence after 3.8 years compared with melanoma patients who did not use the treatment.

“Long-term pegylated interferon therapy in stage III melanoma had a significant and sustained impact on relapse-free survival,” said Alexander Eggermont, MD, PhD, lead investigator and head of the department of surgical oncology, Erasmus University Medical Center, Rotterdam, The Netherlands.

Data were derived from the European Organization for the Research and Treatment of Cancer (EORTC) 18991 randomized phase III trial, which was the largest positive adjuvant trial ever conducted in patients with stage III melanoma. Findings were published in a recent issue of the journal Lancet. Researchers divided study participants into two arms; roughly half of the volunteers (n = 627) received Pegintron following surgery and the other half (n = 629) underwent observation.

Participants randomized to pegylated interferon alfa-2b received a dose of 6 micrograms/kg/week for an eight week induction phase followed by 3 micrograms/kg/week (maintenance phase), for five years. Patients randomized to observation received no study treatment.

During the nearly four-year median follow-up, the researchers found the risk of cancer returning was reduced by 18% for those on Pegintron. Among other significant findings, the relapse-free survival (RFS) rate, after roughly four years, was 46% compared with 39% in the observation arm. Median RFS was 34.8 months and 25.6 months in the peginterferon alfa-2b and observation alfa- 2b arms, respectively (difference of 9.2 mo). The improvement in RFS was more pronounced in patients with a lower tumor burden in the lymph nodes based on predefined subgroups.