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Phase 1 Trial Of All-Oral Ricolinostat-Revlimid-Dexamethasone Combo Begins – Acetylon Pharmaceuticals announced last week the initiation of a Phase 1b clinical trial of ricolinostat (ACY-1215) in combination with Revlimid (lenalidomide) and dexamethasone (Decadron) for the treatment of patients with relapsed or refractory multiple myeloma. Ricolinostat is an oral treatment that belongs to a family of anti-cancer drugs called HDAC inhibitors. Other HDAC inhibitors under investigation for multiple myeloma include Zolinza (vorinostat) and panobinostat. Acetylon believes that ricolinostat could produce fewer side effects than other non-specific HDAC inhibitors, as it selectively inhibits the enzyme HDAC6. The primary aim of the trial is to establish an optimal dose of ricolinostat over a 28-day treatment cycle and to assess the potential anti-myeloma activity of the three-drug combination. In addition, Acetylon is enrolling patients for a Phase 1/2 trial of ricolinostat in combination with Velcade (bortezomib) and dexamethasone in patients with relapsed or refractory myeloma. For more information on both trials, please see the Acetylon press release and the U.S. clinical trial registry.

Lucatumumab Shows Modest Activity As Single Agent In Relapsed/Refractory Myeloma – Results from a recent Phase 1 study indicate that lucatumumab, an antibody developed by Novartis, is well tolerated in relapsed or refractory myeloma patients; however, the compound only showed modest activity in the study participants. Specifically, 4 percent of patients maintained a partial response for a period of eight months or longer, and 43 percent maintained stable disease. The most common severe side effects included anemia (7 percent), chills (7 percent), and fever (7 percent). Side effects severe enough to limit drug dosage were seen in about 10 percent of patients. Based on these results, the researchers recommend that lucatumumab be tested in combination with other anti-myeloma drugs. For more information, please see the study in the British Journal of Hematology (abstract).

Viracept-Velcade Combo Kills Myeloma Cells Better Than Either Drug Alone – Researchers at the National Cancer Institute have found that a combination of the anti-HIV drug Viracept (nelfinavir) and Velcade kills myeloma cells better than either drug alone in a preclinical study. Viracept belongs to a class of drugs called protease inhibitors and was approved by the FDA to treat HIV in 1997. Both Viracept and Velcade limit a cell’s ability to chop up and discard unwanted proteins. Simultaneous treatment with both drugs resulted in an accumulation of such unwanted proteins in the cell, eventually resulting in cell death. For more information, please refer to the study in Cell Death and Disease.

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OncoPep and Dana-Farber Sign License Agreement For Myeloma Vaccine Technology – The biotechnology company OncoPep has signed a license agreement with the Dana-Farber Cancer Institute in Boston to further develop and commercialize PVX-410, a potential vaccine-based treatment for multiple myeloma. PVX-410 has been shown to stimulate an immune response against myeloma cell lines. Researchers plan to conduct a Phase 1/2a study this year of PVX-410 in patients with smoldering multiple myeloma.  OncoPep also hopes to use the PVX-410 technology to develop additional cancer vaccines. For more information, please see the OncoPep press release (pdf).

Celgene Invests $15 Million In Acetylon Pharmaceuticals – Celgene, the company that markets the myeloma treatments Revlimid (lenalidomide) and thalidomide (Thalomid), announced last week that it will invest $15 million in Acetylon Pharmaceuticals. Acetylon is developing ACY-1215, a selective HDAC inhibitor being investigated in a Phase 1/2  clinical trial with relapsed/refractory multiple myeloma patients. Other HDAC inhibitors under investigation for multiple myeloma include Zolinza (vorinostat) and panobinostat. Acetylon hopes that ACY-1215, which is more selective than other HDAC inhibitors, will be more effective and have fewer side effects. For more information, please see the Acetylon press release.

Anti-Alcoholism Drug Antabuse May Be Active Against Myeloma – In a recent preclinical study, Italian researchers demonstrated that Antabuse (disulfiram), a drug approved by the U.S. Food and Drug Administration to treat chronic alcoholism, has anti-myeloma effect. Antabuse, alone or in combination with copper, killed myeloma cell lines and cells from 22 newly diagnosed and relapsed/refractory myeloma patients. According to the Italian researchers, Antabuse was comparable to standard chemotherapy in terms of its ability to kill myeloma cells, but it did not harm healthy blood cells. For more information, please see the study in the International Journal of Cancer (abstract).

Generic Zometa Recommended For Approval In Europe – Zoledronic Acid Actavis, a generic version of Zometa (zoledronic acid) from the company Actavis, has received a positive recommendation for approval in the European Union.  The committee that provides guidance to the European Medicines Agency (EMA) made the recommendation last week.  If approved, Zoledronic Acid Actavis, like Zometa, will be available for use in the prevention of skeletal events in persons with advanced cancers involving bone, and for the treatment of tumor-involved high calcium levels. For more information, see the EMA announcement (pdf).

Cyclophosphamide-Velcade-Dexamethasone Combination Is Effective In Patients With Amyloidosis – Two research studies were published last week showing that a combination regimen used in the treatment of myeloma -- cyclophosphamide (Cytoxan) in combination with Velcade (bortezomib) and dexamethasone (Decadron), often abbreviated CyBorD or VCD -- may be effective in the treatment of amyloidosis. Amyloidosis is a blood disorder that results in the abnormal accumulation of proteins in tissues and organs throughout the body.  An estimated 10 percent to 15 percent of myeloma patients also develop symptoms associated with amyloidosis (see related Beacon news). Stem cell transplantation is a standard treatment for amyloidosis patients who are eligible. One of the studies published last week was a retrospective study that showed that 94 percent of amyloidosis patients responded to CyBorD treatment, and 18 percent of patients who were initially ineligible for a stem cell transplant became eligible following the treatment. The second study also was a retrospective analysis.  It found that 81 percent of amyloidosis patients responded to CyBorD treatment, and researchers also observed a rapid improvement in patients’ organ function.  For more information, please see the first and second studies in the journal Blood (abstracts).

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Viracept Demonstrates Anti-Myeloma Activity – Results of a recent preclinical trial show that Viracept (nelfinavir), alone or in combination with other common myeloma drugs, prevents myeloma cell growth and causes cell death. Viracept is a protease inhibitor and is approved in the United States and Canada for the treatment of HIV.  Studies have suggested that protease inhibitors such as Viracept may be effective against cancer.  It is thought that they may work similarly to proteasome inhibitors like Velcade (bortezomib), In this preclinical study, Viracept enhanced the anti-cancer activity of myeloma drugs Velcade and dexamethasone (Decadron) as well as the epilepsy drug -- and potential anti-cancer agent -- valproic acid (Depakote, Depakene).  Viracept also slowed tumor growth in mice with myeloma. For more information, see the study in Haematologica (pdf).

Study Helps Demonstrate How Green Tea Fights Myeloma – EGCG, an active compound in green tea, has previously been shown to have cancer preventative and cancer fighting properties.  However, little was known about the way EGCG works to fight cancer.  In this recent preclinical study, Japanese researchers showed that EGCG works by disrupting the outer membrane of myeloma cells, but not healthy cells, thereby selectively killing myeloma cells. For more information, please see the study in Biochemical Journal (pdf).  For information about green tea blocking the effectiveness of Velcade, see related Beacon news.

ACY-1215 In Combination With Velcade Shows Potential As Myeloma Treatment – The results of a recent preclinical study show that low doses of ACY-1215 in combination with Velcade kill multiple myeloma cells. ACY-1215, which is being developed by Acetylon Pharmaceuticals, belongs to a class of drugs called HDAC inhibitors. Zolinza (vorinostat) and panobinostat are also HDAC inhibitors that are being studied for the treatment of myeloma. The study showed that ACY-1215 in combination with Velcade slowed tumor growth and extended the overall survival of mice with myeloma. ACY-1215 is currently being studied in a Phase 1/2 clinical trial in combination with Velcade and dexamethasone in patients with relapsed/refractory multiple myeloma. For more information or to enroll in the trial, please see the study in Blood (abstract) and the clinical trial description.

NVP-HSP990 May Be Active Against Myeloma – Results of a recent preclinical study show that NVP-HSP990, alone or in combination with other myeloma treatments, may be effective at treating multiple myeloma. NVP-HSP990, which is being developed by Novartis (NYSE: NVS), is a heat shock protein 90 inhibitor like tanespimycin, which was in Phase 3 trials for myeloma when its development was halted in 2010.  The recent study showed that NVP-HSP990 killed myeloma cells in the laboratory, and this activity was significantly enhanced in combination with melphalan (Alkeran).  For more information, see the study in Anticancer Research (abstract).

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Weekly Polls About Multiple Myeloma Have Started In The Beacon Forums – The Myeloma Beacon has started conducting “Weekly Polls” in the Beacon forums.  These polls and their related discussions address important myeloma-related questions and are intended to provide useful information and insight for multiple myeloma patients and caregivers.  Each poll will begin on Wednesday and run for one week; results can be viewed at any time.  The first poll question is: How involved are you in your myeloma treatment decisions?  This poll will be open for another two days, so please feel free to vote or join the discussion.

Anti-Nausea Drug Zofran Should Not Be Used In Patients With A Certain Heart Condition – The U.S. Food and Drug Administration (FDA) announced that the pharmaceutical company GlaxoSmithKline will be required to conduct a safety review and to add a warning to the product labels for the anti-nausea drug Zofran (ondansetron).  The updated labels will warn against use in patients with congenital long QT syndrome, a heart condition characterized by irregular heartbeats that may cause fainting, seizures, and sudden death. The revised labels will also recommend electrocardiogram heart monitoring in patients with electrolyte imbalances, congestive heart failure, slow heartbeat, or those taking other medications that can cause QT prolongation. Zofran is a class of drugs used to prevent nausea and vomiting caused by cancer chemotherapy, radiation, and surgery. For more information, please see the FDA press release.

Acetylon Pharmaceuticals Begins Phase 1/2 Clinical Trial Of ACY-1215 For Multiple Myeloma – Acetylon Pharmaceuticals recently announced the start of a Phase 1/2 clinical trial of the investigational drug ACY-1215 for relapsed/refractory multiple myeloma. The study will evaluate the effectiveness of ACY-1215 when taken alone or in combination with Velcade (bortezomib) plus dexamethasone (Decadron). ACY-1215 is an HDAC inhibitor like myeloma drug candidates Zolinza (vorinostat) and panobinostat.  However, ACY-1215 is intended to be more selective than other HDAC inhibitors, meaning that it may have higher efficacy and fewer side effects. For more information about the study or enrollment, please see the Acetylon press release or the clinical trial description.

Study Suggests Myeloma Patients Have Increased Risk Of Developing Kidney Cancer – Results of a recent, large analysis show that multiple myeloma patients may have a higher risk of developing a certain type of kidney cancer than the general population. The study included 34,156 myeloma patients diagnosed between 1973 and 2006. The myeloma patients were 1.9 times as likely to develop renal cell carcinoma as the general population. The study also determined that patients originally diagnosed with kidney cancer were at an increased risk of developing myeloma, suggesting that the two cancers share common risk factors. For more information, please see the article in the British Journal of Urology International (abstract).

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Myeloma Experts From The John Theurer Cancer Center To Field Questions At The Beacon Forums Next Week – During the week of May 23 through 27, multiple myeloma patients and caregivers will have the opportunity to get expert answers to their myeloma-related questions.  Myeloma experts Dr. David Siegel and Dr. David Vesole from the John Theurer Cancer Center in Hackensack, NJ, will answer medical questions posted to the Beacon’s multiple myeloma forums throughout the week.  Research at the John Theurer Cancer Center was instrumental in getting Velcade (bortezomib) approved to treat myeloma.  The center is currently conducting studies on carfilzomib and pomalidomide and was also involved with the myeloma genome sequencing project that was published earlier this year.  Beacon readers are encouraged to begin posting their questions in the forums.

Acetylon And LLS Partner To Develop ACY-1215 For Multiple Myeloma – The Leukemia & Lymphoma Society (LLS) recently partnered with Acetylon Pharmaceuticals to support a Phase 1/2 clinical trial of Acetylon’s drug candidate ACY-1215 for relapsed/refractory multiple myeloma.  ACY-1215 is an HDAC inhibitor like myeloma drug candidates Zolinza (vorinostat) and panobinostat.  However, ACY-1215 is intended to be more selective than other HDAC inhibitors, meaning that it may have higher efficacy and fewer side effects. The Phase 1/2 study will investigate the safety and efficacy of ACY-1215 alone and in combination with Velcade and dexamethasone (Decadron).  Under the agreement, the LLS will provide up to $4.85 million to cover half of the projected costs of the clinical trial.  For more information, please see the Acetylon press release or the clinical trial description.

MMRF Laugh For Life Raises Money for Myeloma Research – The 9^th annual Multiple Myeloma Research Foundation (MMRF) Laugh for Life comedy event held on Monday raised over $620,000.  The money will be used to support the development of new treatments for multiple myeloma.  Cat Greenleaf served as Master of Ceremonies, and comedians John Pinette and Sherry Davey performed.  Additionally, Geraldine Ferraro, who passed away from complications of myeloma in March, was honored with the MMRF Spirit of Hope Award at the event.  For more information, see the MMRF press release.