How Leukemia Clinical Trials are Helping Practitioners Personalize Patient Care

PALM BEACH, Florida, March 26, 2019 /PRNewswire/ -- At present, medical practitioners have few options when they are presented with a patient with leukemia. The Leukemia & Lymphoma Society's website points out that : "It's important that your doctor is experienced in treating patients with acute leukemia or has access to an acute myeloid leukemia (AML) specialist." It lists the three major types of available treatment. "Doctors use several types of treatment for adults with AML, some at different stages: Chemotherapy or other drug therapies (Chemotherapy is the use of potent drugs or chemicals, often in combinations or intervals, to kill or damage cancer cells); Stem Cell transplantation (This may be used with a second phase of chemotherapy); and Clinical trials. (Clinical trials can involve therapy with new drugs and new drug combinations or new approaches to stem cell transplantation.) This is where choosing the clinical trial route may be the best option for all.  A cancer clinical trial is a carefully conducted by doctors to improve the care and treatment of people who have cancer. A treatment that's proven safe and effective in a cancer clinical trial may be approved by the U.S. Food and Drug Administration (FDA) for use as a standard treatment if it meets one or both of the following criteria: 1) It's more effective than the current standard treatment; and 2) It has fewer side effects than the current standard treatment.  Active biotech and pharma companies in the markets this week include Moleculin Biotech, Inc. (NASDAQ:MBRX), Curis, Inc. (NASDAQ: CRIS), Gilead Sciences, Inc. (NASDAQ: GILD), Teva Pharmaceutical Industries Limited (NYSE: TEVA), NantKwest, Inc. (NASDAQ: NK).

The purpose of blood cancer clinical trials (for leukemia for example) is to, improve treatment options, increase survival and improve quality of life. Advances in treatment for blood cancers depend on clinical trials of new therapies or new therapy combinations. Different types of cancer clinical trials are designed to develop and test new and better ways to, diagnose and treat cancer in people, prevent or relieve treatment side effects, help prevent a return of cancer and improve comfort and quality of life for people with cancer. According to the Leukemia & Lymphoma Society, "The initial goal of treatment usually is to get the patient into remission. The long-term goal is to cure the disease."

Moleculin Biotech, Inc. (NASDAQ:MBRX) BREAKING NEWS: Moleculin Biotech today announced positive interim safety and efficacy data from two ongoing open label, single arm Phase 1/2 studies of Annamycin. In the first study, being conducted in the US, four patients have completed treatment at 100 mg/m² with no significant adverse events related to Annamycin, and the study will now proceed to the next higher dose of 120 mg/m². The second trial, taking place in Poland, started at a 120 mg/m² dose of Annamycin and has treated three patients. The first patient treated in that trial received a single course of Annamycin and his bone marrow blasts have reduced from 60% to 11%. Our principal investigator considers this response sufficient for the patient to proceed to consolidation therapy, with the goal of receiving a potentially curative bone marrow transplant. To date in Poland, one patient experienced grade 2 mucositis (which resolved to grade 1 within 2 days) and no other adverse events related to Annamycin have been reported. Trial results for the other two patients treated in Poland will not be known until the second quarter of this year.

"We are very pleased to have completed the treatment of patients in cohort 1 of the US trial and move to the next higher dose," commented Walter Klemp, Moleculin's Chairman and CEO.  "In Poland, we are pleased to have such a positive response at the starting dose level in this trial. Of course the response of a single patient doesn't necessarily predict the outcome of the trial, but this is a great way to begin and it's consistent with our expectations for Annamycin."

Mr. Klemp continued: "One of the advantages we believe Annamycin will offer is a lack of cardiotoxicity. We have seen no evidence of cardiotoxicity in any of the patients treated thus far. We intend to advance the clinical study of Annamycin with the goal of ultimately demonstrating the drug's safety and effectiveness to support regulatory approval in the US and European Union." 

Dr. Robert Shepard, Moleculin's Chief Medical Officer for Annamycin added: "A prior clinical trial for Annamycin in acute leukemia demonstrated activity at its Maximum Tolerable Dose of 150 mg/m², so we are pleased for the US trial to move to the next higher dose in cohort 2  of 120 mg/m². In Poland, we consider reducing bone marrow blasts for Patient 1 down to 11% with a single course of Annamycin to be very encouraging. Of course, significant additional study is necessary to definitively demonstrate causality."

"We have begun a second course of Annamycin as a consolidation phase for Patient 1," commented Dr. Lidia Gil, Principal Investigator in the Polish Annamycin clinical trial.  "Considering that this patient was refractory to standard of care induction therapy, I am very pleased to see that Annamycin appears to be showing activity. While this is considered a 'Partial Response,' I believe it's enough of a reduction to serve as a 'bridge to transplant' for this patient.  Importantly, with the first course of Annamycin, no toxicities have been observed that would limit continued dosing with Annamycin."  Read this and more news for MBRX at:  https://www.financialnewsmedia.com/news-mbrx/   

Other recent developments in the biotech industry include:

Curis, Inc. (NASDAQ: CRIS) a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, recently announced that it has entered into an agreement with funds managed by Oberland Capital Management, LLC ("Oberland Capital") for up to $135.7 million in exchange for selling rights to a portion of royalty revenues on worldwide net sales of Erivedge.

Under the terms of the agreement, Curis received $65.0 million in an upfront cash payment, plus Curis is entitled to receive up to an additional $70.7 million in milestone payments if future net royalties exceed pre-defined annual and cumulative thresholds. Oberland Capital will receive 100% of the first $13.2 million and 35% thereafter of annual net royalties due to Curis from worldwide net sales of Erivedge, excluding a portion of non-US royalties retained by Curis. At the closing of the transaction, Curis used a portion of the sale proceeds to retire existing debt, with remaining proceeds of approximately $30 million, excluding closing costs and related transaction fees, to be used to fund its operations.

Gilead Sciences, Inc. (NASDAQ: GILD) recently announced findings from two studies that support the further development of GS-6207, a novel, selective, first-in-class inhibitor of HIV-1 capsid function, for potential future use as part of long-acting HIV combination therapy. Interim blinded data from a Phase 1 study in healthy trial participants demonstrated that single doses of GS-6207 of up to 450 mg, administered subcutaneously, achieved sustained concentration levels and were well-tolerated. Separately, in vitrodata demonstrated picomolar potency with GS-6207, including against HIV strains resistant to other antiretroviral (ARV) classes. The data were presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle (Session O-06).

"These studies indicate that GS-6207, a first-in-class, investigational capsid inhibitor, may represent a novel approach to HIV treatment due to its long-acting characteristics and potent antiviral activity seen in vitro," said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development, Gilead Sciences. "The data presented at CROI support advancing GS-6207 to the next phase of clinical trials to gain a deeper understanding of its potential role as a long-acting agent for people living with HIV."

Teva Pharmaceutical Industries Limited (NYSE: TEVA) recently announced the launch of a generic version of EXJADE^®1(deferasirox) Tablets for Oral Suspension, 125 mg, 250 mg and 500 mg, in the U.S.

Deferasirox Tablets for Oral Suspension are an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients two years of age and older.

"We're proud to offer an affordable generic treatment option with the launch of Deferasirox Tablets for Oral Suspension in the U.S.," said Brendan O'Grady, EVP and Head of North America Commercial. "We continue striving to enable access to medicines for people living with chronic, complex conditions."

With nearly 500 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the U.S. Currently, one in eight generic prescriptions dispensed in the U.S. is filled with a Teva generic product.

NantKwest, Inc. (NASDAQ: NK)  a leading clinical-stage, natural killer cell based therapeutics company, recently announced that Patrick Soon-Shiong, MD, the company's Chairman & CEO, on March 21, 2019, exercised 17,589,250 warrants with an exercise price of $1.9984 and 1,851,000 options with an exercise price of $2.1983, representing an aggregate cash exercise price of $39.2.

In commenting on the exercise of the warrants and options, Dr. Soon-Shiong said the following: "Since the launch of NantKwest in 2015, the company has made remarkable progress in the development of a true, 'off-the-shelf' and 'ready-to-use' Natural Killer (NK) cell therapy that could be shipped on an 'as needed basis,' just about anywhere in the world. We have successfully established a truly off-the-shelf, cryopreserved product and are now ready to embark on pivotal trials. This advanced manufacturing capability combined with our ability to develop NK cells with high killing activity provides us with a distinct advantage as the leading company developing an immediately available NK cell therapy for patients with cancer."

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