On August 04, 2015 Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) today reported its financial results for the second quarter ended June 30, 2015 (Press release, Momenta Pharmaceuticals, AUG 4, 2015, View Source [SID:1234506993]).

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For the second quarter of 2015, the Company reported total revenues of $44.9 million, consisting primarily of product and milestone revenues relating to the approval and launch of GlatopaTM (glatiramer acetate injection). Momenta reported a net loss of $(2.2) million, or $(0.04) per share for the second quarter compared to a net loss of $(26.2) million, or $(0.51) per share for the same period in 2014. At June 30, 2015, the Company had cash, cash equivalents, and marketable securities of $377.2 million.

"Momenta reached a significant milestone in the second quarter of 2015 with the launch of Glatopa, our second approved complex generic product and the first and only generic version of daily COPAXONE available on the market. We are pleased with Sandoz’s execution of the Glatopa launch and encouraged by the strong initial uptake seen thus far," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "In the second quarter, we also strengthened our balance sheet through a successful equity financing laying the groundwork for the growth and advancement of our biosimilars and novel drug pipelines."

Second Quarter Highlights and Recent Events

Complex Generics:

GlatopaTM, generic version of daily COPAXONE 20 mg (glatiramer acetate injection)

On April 16, 2015, Glatopa was approved by the FDA as the first and only "AP-rated," substitutable generic version of daily COPAXONE 20 mg.

On June 18, 2015, the U.S. Court of Appeals for the Federal Circuit (CAFC) again found the remaining patent on daily COPAXONE 20 mg at issue in Teva’s infringement suit to be invalid.

Sandoz launched Glatopa on June 18, 2015. In the second quarter of 2015, Momenta recorded $19.2 million in product revenues from Glatopa sales, net of a deduction of $9.0 million for reimbursement to Sandoz of the Company’s share of pre-launch Glatopa-related legal expenses.

Under its collaboration agreement with Sandoz, Momenta earned a $10.0 million milestone payment upon Glatopa receiving sole FDA approval and an additional $10.0 million milestone payment upon first commercial sale of Glatopa.
The ANDA for a three-times-a-week generic COPAXONE 40 mg (glatiramer acetate injection), submitted by Sandoz in August 2014, is under FDA review.

Enoxaparin Sodium Injection

In June 2015, the Company and Sandoz amended their enoxaparin collaboration agreement replacing the royalty payment with a 50% profit share. The amendment was effective April 1, 2015. In the second quarter of 2015, Momenta earned $0.1 million in product revenues from enoxaparin sales.

The Company continues to pursue the patent infringement case related to Momenta’s U.S. Pat. 7,575,886 against Amphastar and Teva. In a 2012 decision, the CAFC vacated a preliminary injunction based on the Hatch Waxman "safe harbor" (Momenta Pharmaceuticals vs. Amphastar Pharmaceuticals, Inc. Fed. Cir. Aug. 3, 2012). On May 4, 2015, the CAFC held a hearing on the Company’s appeal of summary judgment, and requested the views of the U.S. Solicitor General on the government’s interpretation of the safe harbor provision. On July 13, 2015, the U.S. Solicitor General filed its brief providing support of Momenta’s interpretation of the "safe harbor". A CAFC decision is expected in 2015.

Biosimilars:

M923, a biosimilar version of HUMIRA (adalimumab), is currently being studied in a randomized, double-blind, single-dose study in healthy volunteers to compare its pharmacokinetics, safety, tolerability and immunogenicity versus HUMIRA. Momenta and Baxalta (formerly Baxter) expect to have data from this study in the fourth quarter of 2015. The target date for the first regulatory submission for approval is 2017.

Momenta continues to develop M834, a biosimilar version of ORENCIA (abatacept), and its portfolio of other biosimilar candidates and is in active discussions with potential collaboration partners to assist in their development and commercialization.
On July 2, 2015, Momenta filed a petition for Inter Partes Review (IPR) with the Patent Trial and Appeal Board to challenge the validity of Bristol Myers Squibb’s ORENCIA subcutaneous formulation U.S. Pat. 8,476,239. The Company expects a decision on institution of the IPR in January 2016.

Novel Drug:

Necuparanib (novel oncology candidate)

Momenta’s Phase 2 trial to evaluate the antitumor activity of necuparanib in combination with Abraxane (nab-paclitaxel) plus gemcitabine, versus Abraxane plus gemcitabine alone, is currently enrolling. The Company expects to have clinical data available in the first half of 2017.
Momenta presented updated data from its Phase 1 study evaluating necuparanib in combination with Abraxane and gemcitabine in patients with metastatic pancreatic cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting on June 1, 2015. Necuparanib showed acceptable safety, tolerability, and encouraging signals of activity in the updated Phase 1 dataset.

Autoimmune Drugs

Momenta’s three novel autoimmune candidates are in preclinical development. These candidates include a hyper-sialylated IVIg (hsIVIg), a high potency alternative to IVIg, and two recombinant molecules: M230, a Selective Immunomodulator of Fc receptors (SIF3) and M281, an anti-FcRn monoclonal antibody. The Company is advancing the recombinant candidates with a goal of entering the clinic in late 2016, and is continuing its efforts to identify and explore potential partnering opportunities for the further development and commercialization of its hsIVIg program.

Second Quarter 2015 Financial Results

Total revenues for the second quarter of 2015 were $44.9 million compared to $11.0 million for the same period in 2014. Total revenues for the second quarter of 2015 include $19.2 million in product revenue, which represents 50% of contractual profit earned from net sales of Glatopa by Sandoz, net of a deduction of $9.0 million in reimbursement to Sandoz of the Company’s share of pre-launch Glatopa-related legal expenses.

Enoxaparin product revenue for the second quarter of 2015 was $0.1 million compared to $5.7 million in the same period in 2014. The decrease in enoxaparin product revenue was primarily due to the amendment of the enoxaparin sodium injection collaboration agreement in June 2015 which replaced Sandoz’ obligation to pay the Company a royalty on net sales with an obligation to pay 50% of profit on sales. The amendment became effective for the second quarter of 2015.

Collaborative research and development revenue for the second quarter of 2015 was $25.6 million, compared to the $5.3 million recorded in the same quarter last year. In the second quarter of 2015 the Company earned $20.0 million in milestone payments under the Sandoz collaboration upon receiving sole FDA approval and upon first commercial sale of Glatopa.

Research and development expenses for the second quarter of 2015 were $34.0 million, compared to $26.1 million for the same period in 2014. The increase of $7.9 million, or 30%, from the 2014 period primarily resulted from increases of: $2.2 million in third-party process development costs for the biosimilars programs; $2.0 million in preclinical and manufacturing expenditures to advance the novel autoimmune programs; $1.6 million in clinical trial expenses as the necuparanib Phase 2 clinical trial continued to enroll patients; and $1.4 million in share-based compensation expense associated with performance-based stock awards.

General and administrative expenses for the quarter ended June 30, 2015, were $13.3 million, compared with $11.2 million for the same period in 2014. The increase of $2.1 million, or 19%, from the 2014 was primarily due to an increase of $1.5 million in share-based compensation expenses associated with performance based stock awards.

At June 30, 2015, Momenta had $377.2 million in cash, cash equivalents and marketable securities. This cash position excludes restricted cash of $20.7 million, of which $17.5 million is reserved as collateral for a security bond related to enoxaparin legal proceedings, and $3.2 million for letters of credit related to the company’s two leased facilities.

In May 2015, the Company sold an aggregate of 8,337,500 shares of common stock through an underwritten public offering at a price to the public of $19.00 per share. Momenta received net proceeds of $148.4 million, after deducting underwriting discounts and commissions and customary offering expenses.

In April 2015, the Company concluded sales of its common stock under its May 2014 "At the Market" (ATM) Equity Offering Sales Agreement with Stifel, Nicolaus & Company. In the second quarter of 2015, the Company recorded net proceeds of $21.5 million from the sale of 1.4 million shares of common stock sold through the ATM.

Also in April 2015, Momenta entered into a second ATM agreement with Stifel under which the Company may offer and sell shares of its common stock having an aggregate offering price of up to $75 million. In the second quarter of 2015, the Company recorded net proceeds of $9.3 million from the sale of 0.5 million shares of common stock sold through the 2015 ATM.

Financial Guidance

Today, Momenta provided guidance that it expects its operating expenses, excluding stock-based compensation and net of collaborative revenues, to be approximately $36 – $40 million per quarter for the second half of 2015.

(Filing, 10-Q, Agenus, AUG 3, 2015, View Source [SID:1234506984])

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On August 3, 2015 Arbutus Biopharma Corporation (NASDAQ:ABUS) reported finalization of its corporate name change from Tekmira Pharmaceuticals Corporation (NASDAQ:TKMR) (Press release, Arbutus Biopharma, AUG 3, 2015, View Source [SID:1234510721]). Arbutus Biopharma ("Arbutus") is an industry-leading therapeutic solutions company focused on developing a cure for chronic hepatitis B virus infection (HBV). Arbutus will begin trading under the new ticker symbol ABUS on the NASDAQ today. The company has also received a new CUSIP number (03879J100) for its common stock.

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On August 3, 2015 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported financial results for the three months ended June 30, 2015, and also provided an overview of recent accomplishments and upcoming milestones for its clinical development programs (Filing, 8-K, CytRx, AUG 3, 2015, View Source [SID:1234506975]).

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"The second quarter of 2015 has been very productive for CytRx. Enrollment in our ongoing pivotal global Phase 3 clinical trial of aldoxorubicin in soft tissue sarcoma (STS) continues on track to be completed in the first quarter of 2016. On the financial front, we successfully closed a public equity offering raising an additional $28.8 million in gross proceeds, which significantly strengthens our balance sheet and allows us to further advance the aldoxorubicin program, provide for pre-commercialization launch expenses, and introduce our next generation of therapies into the clinic in 2016," said Steven A. Kriegsman, Chairman and CEO of CytRx. "The second quarter also included the announcement of promising updated data from our Phase 2 programs evaluating aldoxorubicin in Kaposi’s Sarcoma (KS) and glioblastoma (GBM), in addition to compelling data in our two combination trials."

Mr. Kriegsman continued: "We were also pleased to recently unveil our proprietary LADR (Linker Activated Drug Release) technology platform which will be used for the development of our next-generation therapeutic drug conjugates which we may employ as treatments for liver, pancreatic, and non-small cell lung cancers, among others. These conjugates, developed at our laboratory facilities in Freiburg, Germany, will be designed to control release in tumors of high-potency chemotherapeutics that are attached to either albumin or anti-cancer antibodies. We believe this proprietary platform is highly complementary to and builds upon our ongoing global Phase 3 aldoxorubicin program."

Second Quarter 2015 and Recent Highlights

Strengthened the Corporate Balance Sheet. In July 2015, CytRx successfully completed a public offering of common stock securing gross proceeds of approximately $28.8 million. CytRx intends to use the net proceeds of the offering to fund clinical trials of its drug candidate aldoxorubicin and its drug discovery activities and for general corporate purposes, which will include pre-commercialization activities relating to aldoxorubicin, working capital and capital expenditures.

Unveiled proprietary LADR (Linker Activated Drug Release) Technology Platform. In June 2015, CytRx announced its proprietary LADR technology platform, a discovery engine designed to leverage the Company’s expertise in albumin biology and linker technology for the development of a new class of anti-cancer therapies. CytRx expects the LADR platform to rapidly expand its pipeline of oncology drug candidates, providing an avenue for the development of propriety therapies that complement its global Phase 3 aldoxorubicin program. Among the cancers being pursued are liver, pancreatic, and non-small cell lung cancer.

Reported Interim Phase 2 Data for Aldoxorubicin for HIV-Related Kaposi’s Sarcoma. In June 2015, at the 18th International Workshop on Kaposi’s Sarcoma Herpesvirus (KSHV) and Related Agents in Hollywood, Florida, CytRx reported interim results from its ongoing open-label Phase 2 pilot study evaluating the efficacy and safety of aldoxorubicin for the treatment of Kaposi’s Sarcoma (KS) in HIV-infected patients. The preliminary analysis from nine patients who received at least six cycles of aldoxorubicin (mean = 6.3 cycles), four of whom had received prior Doxil chemotherapy, showed six (67%) demonstrated a partial response (PR) to aldoxorubicin at the end of study visit (EOS), and 7 (78%) demonstrated PR within 4 months of EOS. Most importantly, doxorubicin could be detected in all tumor biopsies and higher doxorubicin concentrations were demonstrated within KS lesions relative to skin next to the lesions for 3/4 (75%) patients for whom adequate tissue was available for analysis. Five of 6 (83%) patients receiving aldoxorubicin and for whom data are available exhibited reduced intratumoral viral loads during therapy. A subset of patients also exhibited improvements in quality of life during treatment, and all patients exhibited either improvement or stability in immunologic and virologic HIV treatment parameters.

Strengthened the Leadership Team. In June 2015, CytRx appointed Cheryl Cohen to its Board of Directors. Ms. Cohen served as the Chief Commercial Officer of Medivation, Inc., from September 2011 to July 2014, where she built the company’s commercial framework and led its successful launch of Xtandi in the United States. Her experience will be highly valuable as the Company prepares for the commercialization of aldoxorubicin.

Reported Aldoxorubicin Cardiotoxicity Data in a Poster Presentation at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. In May 2015, in a poster presentation at ASCO (Free ASCO Whitepaper), CytRx reported cardiotoxicity data from 200 patients across 7 clinical trials (1 Phase 3, 3 Phase 2 and 3 Phase 1) evaluating aldoxorubicin. The results showed that none of the patients exhibited a decrease in left ventricular ejection fraction (LVEF) that was below 50% of their institution’s normal value. 14% of patients demonstrated a ≥ 10% drop in LVEF and 21% had a ≥ 10% increase in LVEF. Other side effects observed were consistent with effects seen in other anthracycline treatments. Patients in these trials have received up to 5,439 mg/m2 of doxorubicin equivalents, or 12 times the peak cumulative dose of standard doxorubicin, without any evidence of cardiotoxicity. These results suggest that aldoxorubicin can be safely administered at cumulative doses of over 2 g/m2 without evidence of cardiotoxicity.

Reported Positive Updated Phase 2 Aldoxorubicin Clinical Trial Results in Glioblastoma Multiforme (Brain Cancer). In May 2015, CytRx reported positive updated data from its open-label, multisite trial in evaluating the preliminary efficacy and safety of aldoxorubicin in patients whose tumors have progressed following prior treatment with surgery, radiation and temozolomide. The updated trial results in 18 patients showed three pathological complete responses, as well as tumor shrinkage and prolonged stable disease. Aldoxorubicin was also well tolerated.

Reported Positive Interim Results from two Phase 1b Aldoxorubicin Trials in Chemotherapy Resistant Cancers. In May 2015, the Company announced positive interim results from its two ongoing Phase 1b clinical trials evaluating aldoxorubicin in chemotherapy resistant cancers. Interim results from seven patients in the first study, evaluating the preliminary safety and activity of ascending doses of aldoxorubicin plus ifosfamide/mesna for the first-line treatment of patients with locally advanced, unresectable, and/or metastatic sarcomas, show that the combination of aldoxorubicin plus ifosfamide/mesna was well tolerated, with one bone cancer patient achieving a complete tumor response (as assessed by PET/CT scan) following five treatment cycles. Interim results from seven patients in the second study, evaluating the preliminary safety and activity of ascending doses of aldoxorubicin plus gemcitabine in patients with advanced, unresectable, metastatic solid tumors that have either relapsed or were refractory to treatment following at least one prior chemotherapy or immunotherapy regimen, show that the combination of aldoxorubicin plus gemcitabine was well tolerated, with tumor shrinkage observed in three of seven patients following two treatment cycles. One patient with a history of chronic severe pain and inability to function normally demonstrated meaningful quality of life improvements, including stopping prescription narcotic pain medications and returning to work full-time. These results suggest that aldoxorubicin in combination with other chemotherapeutic agents has the potential to bolster anti-cancer activity.

Announced the Publication of a Clinical Case Study of Aldoxorubicin in Glioblastoma. In April 2015, the Company announced the publication of a case study, titled "Albumin-Linked Doxorubicin (Aldoxorubicin) as Treatment for Relapsed Glioblastoma: A Case Report," in the Journal of Nuclear Medicine & Radiation Therapy. In a 54 year old male patient with recurrent left parietal lobe glioblastoma multiforme (GBM) who was administered a single cycle of intravenous aldoxorubicin 350 mg/m2 (260 mg/m2 doxorubicin equivalents), histopathological assessment of tissue following a subsequent tumor debulking procedure showed no evidence of recurrent glioblastoma throughout the entire surgical specimen. These findings suggest that aldoxorubicin allows doxorubicin to cross the tumor’s blood-brain barrier in humans and induce tumor necrosis (tumor cell death). The full publication can be accessed here.

Upcoming Milestones

· Complete enrollment in the first quarter of 2016 in the ongoing pivotal global Phase 3 clinical trial of aldoxorubicin as a second-line treatment for STS under a Special Protocol Assessment, or SPA, granted by the FDA, with PFS data announced in the second half of 2016

· Report further results from its ongoing Phase 2 clinical trial of aldoxorubicin in patients with unresectable GBM by year-end 2015

· Report further results from its ongoing Phase 2 clinical trial of aldoxorubicin for the treatment of KS in HIV-infected patients by year-end 2015

· Complete enrollment in the ongoing Phase 1b clinical trial with a combination of aldoxorubicin and ifosfamide/mesna as first-line treatment for advanced sarcomas in the second half of 2015

· Complete enrollment in the ongoing Phase 1b clinical trial with a combination of aldoxorubicin and gemcitabine in metastatic solid tumors in the second half of 2015

· Complete enrollment in the ongoing Phase 2b clinical trial of aldoxorubicin in relapsed/refractory small cell lung cancer in the first quarter of 2016, with PFS data expected by the second half of 2016

· Announce a new oncology pipeline drug candidate, which utilizes novel linker technologies that couple chemotherapeutic agents and proteins either inside the body or externally, and then concentrate drug in tumors, in 2015

Second Quarter 2015 Financial Results

CytRx reported cash, cash equivalents and short-term investments of $53.8 million as of June 30, 2015.

Net loss for the three months ended June 30, 2015 was $11.7 million, or $0.21 per share, compared with a net loss of $15.7 million, or $0.28 per share, for the three months ended June 30, 2014. The decrease of $4.0 million in net loss during the current three-month period resulted primarily from a gain of $2.4 million on warrant derivative liability in the current quarter, as compared to a loss on warrant derivative liability of $2.5 million in the comparative 2014 period, for a difference of $4.9 million.

Research and development (R&D) expenses were $10.0 million for the second quarter of 2015, and included development expenses of $8.2 million for aldoxorubicin. The remaining $1.8 million of R&D expenses were primarily related to research and development support costs. R&D costs were $10.4 million for the second quarter of 2014.

General and administrative (G&A) expenses were $4.2 million for the second quarter of 2015, compared with $2.9 million for the second quarter of 2014. G&A expenses for the second quarter of 2015 included non-cash employee stock-compensation expense of $1.7 million, compared to $0.3 million for the same period in 2014.

About Soft Tissue Sarcoma

Soft tissue sarcoma is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue, and can arise anywhere in the body at any age. According to the American Cancer Society, there are approximately 50 types of soft tissue sarcomas. In 2013 more than 11,400 new cases were diagnosed in the U.S. and approximately 4,400 Americans died from this disease. In addition, approximately 40,000 new cases and 13,000 deaths in the U.S. and Europe are part of a growing underserved market.

About SCLC

An estimated 1.6 million new cases of lung cancer are diagnosed worldwide each year. In the Western world, approximately 13-15% of cases are SCLC, a deadly form of lung cancer associated with tobacco use. The five year survival rate is less than 7%, in part because an estimated 70% of patients have extensive disease at diagnosis. According to the National Cancer Institute, more than 30,000 new cases will be diagnosed in the USA in 2014. The estimated 2014 SCLC incidences for Europe and Asia are over 58,000 and 136,000, respectively.

About Glioblastoma Multiforme

Glioblastoma is the most common and most malignant primary brain tumor in adults and afflicts more than 12,000 new patients in the U.S. annually. The median survival after diagnosis is approximately 14 months, despite patients subsequently receiving surgical resection, radiotherapy and chemotherapy. Limited efficacy of chemotherapeutic agents has been attributed to several contributing factors including insufficient drug delivery to the tumor site through the blood:brain barrier.

About Kaposi’s Sarcoma

Kaposi sarcoma is a cancer that causes lesions (abnormal tissue) to grow in the skin; the mucous membranes lining the mouth, nose, and throat; lymph nodes; or other organs. The lesions are usually purple and are made of cancer cells, new blood vessels, red blood cells, and white blood cells. Kaposi sarcoma is different from other cancers in that lesions may begin in more than one place in the body at the same time. KS remains the most common HIV-associated tumor worldwide. The condition is also endemic in certain parts of Central Africa and Central and Eastern Europe.

About Bone Cancers (Osteosarcoma, Chondrosarcoma)

Bone cancer is a highly aggressive type of cancer that develops in bone. It starts in immature bone cells (osteoblasts) that normally form new bone tissue. According to the National Cancer Institute, there are approximately 3400 new cases of bone and joint cancer diagnosed each year in the United States, with approximately half of these occurring in children and teens. In addition, the estimated deaths in the U.S. were 1,460 in 2014. Although they can arise in any bone in the body, the most frequent sites are at the ends of the long bones of the legs and arms. In most cases, treatment consists of both chemotherapy and surgery, but patients with metastatic bone cancer continue to have a poor 5-year survival rate (15-30%).

About Aldoxorubicin

The widely used chemotherapeutic agent doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 450 mg/m2. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin, thus increasing the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. This allows for greater doses (3 ½ to 4 times) of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2,000 mg/m2.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. CytRx currently is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin. CytRx is also seeking to expand its pipeline of oncology candidates at its laboratory facilities in Freiburg, Germany, through its LADR (Linker Activated Drug Release) technology platform, a discovery engine designed to leverage CytRx’s expertise in albumin biology and linker technology for the development of a new class of anti-cancer therapies.

On August 3, 2015 CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") reported that in July it has enrolled 33 patients in its ongoing Phase 3 trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary head and neck cancer (Press release, Cel-Sci, AUG 3, 2015, View Source [SID:1234506982]). This marks a new monthly record. Total study enrollment now stands at 521 patients as of July 31, 2015 in the world’s largest Phase 3 study in head and neck cancer.

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"We continue to deliver record monthly enrollment numbers, which are in line with our expectations and bring us to over 500 patients enrolled in our Phase 3 study as of the end of July," stated CEL-SCI Chief Executive Officer Geert Kersten.

A total of 880 patients are expected to be enrolled, through approximately 100 clinical centers in over 20 countries.

About the Multikine Phase 3 Study

The Multikine Phase 3 study is enrolling just diagnosed, not yet treated patients with advanced primary squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care ("SOC") vs. subjects who are treated with SOC only. Standard of care for these patients consists of the surgical removal of the tumor and any locally involved lymph nodes, followed by radiotherapy or concurrent radiochemotherapy.

About Multikine

Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase 3 clinical trial as a potential first-line treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.

Multikine is also being tested in a Phase 1 study under a Cooperative Research and Development Agreement ("CRADA") with the U.S. Naval Medical Center, San Diego, and at University of California, San Francisco (UCSF), as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. CEL-SCI has also entered into two co-development agreements with Ergomed Clinical Research Limited to further the development of Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.