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Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.Acorda Therapeutics, Inc. (Nasdaq: ACOR) announced Ron Cohen, M.D., President & CEO, will present at the upcoming Lazard Capital Markets 6th Annual Healthcare Conference on Tuesday, November 17, 2009 at 3:10 p.m. ET at the St. Regis Hotel in New York, NY.Agilent Technologies Inc. (NYSE:A) announced it has purchased the MassCode Tag technology from Eurofins MWG Operon, a division of Eurofins.
ArQule, Inc. (Nasdaq: ARQL) presented data at the AACR-NCI-EORTC meeting in Boston demonstrating the capabilities of the Company’s proprietary drug discovery platform to generate a class of small molecules with significant therapeutic potential.Art's Way Manufacturing, Inc. (Nasdaq: ARTW), announces its wholly owned subsidiary, Art's Way Scientific, Inc. - Buildings For Science - will be providing 6 modular swine facilities for breeding, gestation, farrowing, nursery and finisher operations.BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), a specialty pharmaceutical company developing products for female sexual health, including LibiGel® for th treatment of hypoactive sexual desire disorder (HSDD), applauds the efforts of Boehringer Ingelheim to develop a therapy to treat this unmet medical need. Cannabis Science Inc. (NASD OTCBB: CBIS) an emerging pharmaceutical cannabis company, is hailing the call by the American Medical Association's House of Delegates for “marijuana's status as a federal Schedule I controlled substance be reviewed with the goal of facilitating the conduct of clinical research and development of cannabinoid-based medicines."Cadus Corporation (OTC Bulletin Board: KDUS) announced financial results for the third quarter ended September 30, 2009.Derma Sciences, Inc. (OTC Bulletin Board: DSCI) a specialty medical device/pharmaceutical company focused on advanced wound care, announced it has filed an S-1 Registration Statement to offer 1,500,000 shares of its common stock. Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) announced data from its pipeline programs will be presented at the 2009 EORTC-NCI-AACR (European Organization for Research and Treatment of Cancer-National Cancer Institute-American Association for Cancer Research) annual meeting being held November 16-19, 2009 in Boston, Massachusetts.Exact Sciences Corp. (Nasdaq: EXAS) announced it will present at the Lazard Capital Markets Sixth Annual Healthcare Conference, which is being held Nov. 17-18, at the St. Regis Hotel in New York.Health Grades, Inc. (Nasdaq: HGRD), the leading healthcare ratings company, announced Kerry Hicks, President and Chief Executive Officer of Health Grade, will be presenting at the Sidoti & Company, LLC New York II Emerging Growth Institutional Investor Forum at The Grand Hyatt Hotel in New York on Friday, November 20, 2009, at 8:30 a.m. Eastern time.Inovio Biomedical Corporation (NYSE AMEX: INO) reported financial results for the three and nine months ended September 30, 2009.Mead Johnson Nutrition Company (NYSE: MJN) announced it intends to file a Registration Statement on Form S-4 with the Securities and Exchange Commission (SEC), which includes details of a proposed exchange offer whereby Bristol-Myers Squibb Company (BMS) shareholders can exchange some, none or all of their shares of BMS common stock for shares of Mead Johnson common stock.Metabolix, Inc. (NASDAQ: MBLX), a bioscience company focused on developing sustainable solutions for plastics, chemicals and energy, announced the complete on of its previously announced underwritten public offering of 3,450,000 shares of its common stock at a price of $9.00 per share for gross proceeds of approximately $31 million. NovaDel Pharma Inc. (NYSE:NVD), a specialty pharmaceutical company developing oral spray formulations for a broad range of marketed treatments, reported financial results for its third quarter and nine months ended September 30, 2009.Neogen Corporation (Nasdaq: NEOG) announced that its Board of Directors has approved a 3-for-2 stock split. OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced the Oncologic Drugs Advisory Committee (ODAC) will review the use of Tarceva® (erlotinib) as a first-line maintenance therapy for patients with advanced non-small cell lung cancer (NSCLC) who have not progressed following first-line treatment with platinum-based chemotherapy at its December 16, 2009 meeting.PPD, Inc. (Nasdaq: PPDI) announced it has entered an agreement with Janssen Pharmaceutica N.V. to develop and commercialize two Phase II-ready therapeutic compounds, one to treat diarrhea-predominant irritable bowel syndrome (IBS-d) and the other to treat complicated skin and skin structure and respiratory infections.Roche`s (SWX:RO) (SWX:ROG) (Pink Sheets: RHHBY) RealTime ready Influenza A/H1N1 Detection Set for the 2009 H1N1 influenza virus has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA). Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI), a commercial-stage biotechnology company with a primary focus in oncology, announced it has been selected for addition to the NASDAQ Biotechnology Index® (Nasdaq: NBI).Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics™, announced it has been selected for addition to the NASDAQ Biotechnology Index (NASDAQ: NBI) effective with the U.S. market open on Monday, November 23, 2009.ZOLL Medical Corporation (Nasdaq GS: ZOLL), a manufacturer of medical devices and related software solutions, announced the R Series® defibrillators with new monitoring capability added as well as its new intravascular temperature management solutions are being exhibited in Booth #1417 at the American Heart Association Scientific Sessions 2009 November 15-17th at the Orange County Convention Center in Orlando.
EXACT Sciences (NASDAQ: EXAS) is a molecular diagnostics company that is developing a next-generation (V3), stool DNA (sDNA) based screening test for colorectal cancer (CRC) which has demonstrated the ability to detect both early-stage cancer and pre-cancerous growths. The Company's sDNA-based screening technology platform has also demonstrated the ability to detect related GI cancers and pre-cancers.
Only 24% of an estimated 90 million individuals in the U.S. are currently compliant with CRC screening recommendations, which results in an estimated 68 million people who are non-compliant. The early detection of CRC saves both lives and money by avoiding the high costs of dealing with late-stage disease through expensive anti-cancer drugs and/or palliative care. Late stage (III/IV) CRC accounts for 60% of diagnoses, but the five-year survival rates for Stage III CRC is 60% and just 11% for Stage IV disease. Compare those statistics to early stage disease, which includes a 90% five-year survival rate for Stage I CRC and 70% for Stage II.
The ProActive News Room landing page for EXAS has been updated to include my 3Q09 update report, which is also available to view or download as a PDF at the BioMedReports.com research downloads section . Below is the earnings model that I have updated for EXAS, in addition to a summary of updates since my 2Q09 report. The earnings model below highlights the significant market opportunity for EXAS, including estimated earning power of approximately $6 / share in 2013. Applying a 50% discount rate for three years yields a $15 fair value estimate for shares of EXAS.
1.) Since my 2Q09 update report for EXAS in mid-August, the share price is essentially flat (from $2.59 to $2.63), the three-month average daily trading volume has declined 37.5% (from 104,000 to 65,000), the short interest has increased by 21,000 shares (to 162,000), and cash / equivalents have decreased by $0.9 million to a level of $26.9 million.
2.) Data is expected by 3Q10 to provide external validation of the Company's stool DNA based CRC test kit while a clinical trial to support marketing clearance of the CRC test kit from the FDA is expected to begin during 2Q-3Q11. EXAS expects total costs of approximately $15-20 million for the FDA study, which will involve 20-30 sites.
3.) A submission to the FDA for marketing clearance is expected during 2012 via the 510(k) de novo route (since no predicate device exists with FDA marketing clearance). EXAS has received extensive input from the FDA for the design of this clinical trial and will remain in close contact with the Agency, following the same model of success applied at Third Wave for that Company's HPV test.
4.) EXAS provided guidance for an average cash burn rate of about $1 million per month during 2010, which is expected to increase slightly as the Company continues to expand and adds additional personnel.
5.) EXAS expects a reimbursement rate of $300 for its next-generation (V3) stool DNA based test kit for CRC while the Company expects to receive approximately $150 per kit from the U.S. labs that would offer / license the test kit, in addition to gross margins in excess of 65% (about $100 per test kit in gross profits).
6.) EXAS has thoroughly examined blood-based detection tests for CRC in collaboration with industry experts and concluded the technology is not commercially or clinically feasible at this time given very low detection of pre-cancer (18%) and early-stage (Stage I) CRC (36%) along with a 10% false positive rate. In addition, virtual colonoscopy entails a significant dose of radiation, cannot detect flat lesions, requires a full colon cleanse, and may still require a follow-up colonoscopy. Existing FIT / FOBT fail to detect pre-cancers and early-stage disease at meaningful rate.
7.) In March, EXAS conducted a management overhaul that included Mr. Conroy and CFO Maneesh Arora, following their successful tenure at Third Wave Technologies. In early August, EXAS announced the appointment of Graham P. Lidgard, Ph.D., as Chief Scientific Officer, who has over three decades of clinical / molecular diagnostics experience and a successful track record at Gen-Probe (NASDAQ: GPRO). Other key collaborations include the Mayo Clinic (Dr. David Ahlquist), Johns Hopkins (Dr. Bert Vogelstein), Genzyme (NASDAQ: GENZ), Case Western Reserve (Dr. Sandy Markowitz).
8.) In late October, EXAS made a SEC 8-K filing regarding its President / CEO, Kevin T. Conroy, who is considering a run for Governor of Wisconsin in 2010. Mr. Conroy stated on the 3Q09 conference call today a succession plan would be premature at this point, and he plans to make a decision in the very near future on whether to make the run for governor (this would be communicated in the form of another SEC 8-K filing) - indicating that he is only considering such a move because of confidence in the strong team that is already in place at EXAS.
The BioMedReports.com FDA Calendar service includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results. Coming soon is a premium service offered in collaboration with Investars YOU for full access to a global database of over 1,000 stocks which are organized and managed within my 22 ProActive HavRx stock indexes . This service will allow investors to create custom portfolios, personalized exchange-traded funds (ETFs), and generate investment ideas based on their personal preferences, beliefs, and opinions through specialized stock indexes that are organized and targeted toward a wide variety of themes.
1.) A 53% increase in diagnostic lab revenues during 2Q09 from the year-ago period
2.) A 17% sequential decline in diagnostic lab revenues from the prior quarter due to temporary factors that are expected to be resolved in near-term
3.) Leuchemix clinical trials are progressing well
4.) Positive data was reported on the Company's Comprehensive Cancer Array (CCA) test, which is currently in development
The Company attributed its sequential revenue decline to non-recurring events including a short delay in the initiation of a funded, 200-patient prostate cancer study that is now expected to be completed by the end of 2009. Also, CBMX was unable to perform its tests for residents of the state of New York (NY), which represents one of its fastest growing markets.
When new tests are developed, NY allows them to be operated on residents for a certain period of time but eventually requires state licensure (in addition to CLIA licensure) for high complexity tests. During 2Q09, NY informed the Company that it was no longer acceptable to offer its tests under the exemption and state licensure was required. CBMX has applied for the license and hopes to receive approval shortly.
CBMX also announced that it is seeking to engage an investment bank to aid in its efforts to unlock shareholder value and hopes to hire and announce an engagement very shortly. The Company stated that it has reached an inflection point in its strategy and has a relatively strong balance sheet with approximately a year of cash reserves remaining as well as an additional potential payment of about $36 million from a previously awarded court judgment against National Union that is pending a final ruling on appeal by the latter.
The Company stated that in addition to its diagnostic assets, it owns other assets that include an ownership position (one-third stake) in the experimental anti-cancer drug Leuchemix, which is being evaluated in a dose-escalating Phase 1 safety study in England with a goal of completing a Phase 2 trial by mid-2010 and seeking a partnership to fund Phase 3 development. The CEO stated that CBMX has conducted discussions with some companies that have expressed interest in acquiring or partnering with the Company or certain portions thereof.
CBMX also provided the following corporate, product, and technology updates:
1.) In April 2009, Dr. Karine Hovanes joined the Company's wholly owned subsidiary, CombiMatrix Molecular Diagnostics, Inc. (CMDX), as Laboratory Director.
2.) Also in April 2009, CBMX announced that its Influenza-Detection Microarray was updated to include sequence information covering the latest strain of swine flu.
3.) In May 2009, CBMX provided a link on its website for a presentation by its CEO, Dr. Amit Kumar, regarding the latest developments for its non-invasive, array-based cancer screening test (CCA)
4.) In June 2009, the Company was featured in a report that was broadcast on CNBC after announcing that a validation study of its HerScan breast cancer test was now available as advance online publication in the official journal of the United States and Canadian Academy of Pathology, Modern Pathology.
5.) In June 2009, CBMX announced that all of the appellate briefs associated with ongoing litigation against National Union were filed with the U.S. Ninth Circuit Court of Appeals and that the next step in the appellate process is for the Court to schedule oral hearings. A final decision could be reached during 4Q09, resulting in a major cash windfall to the Company which is nearly equal to its current market cap of about $50 million (7.5 million shares outstanding X $6.63/share).
Preliminary results for the CCA test have demonstrated that it can non-invasively screen for the early detection of cancer, focusing on prostate, colon, ovarian, breast, and lung cancers (which account for about 85% of all solid tumors in the U.S.). The study showed that the miRNA (type of nucleic acid) expression patterns in the blood for patients with cancer (including early stage 1) were very different from patients who were cancer-free. An analysis of results indicated that a clear distinction could be made between patients with cancer and those without.
A broad-based, early detection test for cancer would have tremendous market potential and fits well with the focus on preventive medicine by the new administration. This early warning system for cancer is designed to be a non-invasive, blood screening test which would require confirmation of results by a follow-up, invasive method such as a biopsy. CBMX estimates the market potential for the CCA at several billion dollars per year in the U.S. alone, which is based on $250 per test administered to 50M people each year over the age of 40 who are believed to have an annual physical exam.
On 5/13/09, CBMX announced that its goal is to complete the R&D phase for the first version of the array by the end of the third quarter of 2009. While the initial focus is on colon, lung, breast, ovarian, and prostate cancers, CBMX has not yet publicly disclosed the specific cancers which will be on the first version of the test. By the end of 2009, the final protocols, assay development and quality control metrics are expected to be completed. During 1H10, CBMX hopes to complete clinical trials in anticipation of a commercial launch during 3Q10. In parallel with the development of this array, CBMX will be engaged in partnership discussions.
The Company's CMDX lab division could easily be worth up to 2X the current market cap for CBMX of $50 million based on recent transactions for two companies in my Emerging Diagnostics Index. EXACT Sciences (NASDAQ:EXAS) closed a deal with Genzyme (NASDAQ:GENZ) earlier this year for $24.5 million for the rights to its IP/patent estate in the area of prenatal diagnostics (please note this transaction does not even include a finished test).
In addition, LabCorp (NYSE:LH) recently acquired Monogram Biosciences (NASDAQ:MGRM) for a total value of about $150 million. Monogram’s proprietary VeraTag technology has been used to develop a sensitive means to assess HER-2 status in tissue samples and has significant potential as a tool to help guide therapy decisions in breast cancer patients. Based on the VeraTag platform, Monogram has multiple tests in development for measuring a variety of protein markers that may have clinical utility to help guide treatment decisions across a broad range of cancer drugs.
The Company said it tested doxorubicin with its unique drug delivery technology, Percutaneous Hepatic Perfusion (PHP), which results in significantly higher doses (e.g. 10X the FDA approved standard dosing with 100X exposure of drug to the tumor site) of anti-cancer drugs such as doxorubicin to the liver without exposing the patient's entire body. Delcath plans to carry out the necessary clinical work for a regulatory submission of PHP with doxorubicin.
This ABC News Video describes the PHP system and provides a case study for a patient with liver cancer
On 8/25/09, DCTH reported that it has exceeded 90% enrollment for its pivotal Phase 3 Metastatic Melanoma Trial which will enroll a total of 92 patients. This study is testing the PHP System for the regional delivery of melphalan to the liver to treat patients with metastatic melanoma (a deadly type of skin cancer) who have tumors in the liver, which cannot be removed by surgery (unresectable). On 9/11/09, DCTH reported that the Data and Safety Monitoring Board (DSMB) reviewed clinical data on 77 patients enrolled in its pivotal Phase 3 clinical trial and unanimously recommended that the trial continue to enroll patients with the goal of reaching the 92 patients required to complete the study. DCTH expects enrollment to be completed by mid-October and is still on track for a FDA filing by mid-2010.
Despite the recent run-up in shares of DCTH, the fully diluted market cap is about $130 million and leaves plenty of room for upside with catalysts looming in the near to intermediate term based on news flow from the ongoing pivotal Phase 3 trial of melphalan delivered by PHP. PHP represents a platform technology that can be expanded to the treatment of other cancers (with established, FDA-approved chemotherapy drugs) and other infectious diseases such as hepatitis. The Company also represents a risk-mitigated play since it is seeking to improve the effectiveness of existing chemo drugs by its targeted drug delivery system which greatly increases exposure to the tumor site while sparing healthy tissue outside of the liver.
The Company’s goal is to complete Phase 3 trial enrollment by end of 2009, obtain European marketing approval by mid-2010, and obtain U.S. FDA approval by mid-2011 while seeking development and marketing partnerships to expand and fund the development and commercialization of the PHP system. Delcath has a cash burn rate of just under $1 million per month with $8.9 million in cash at the end of 2Q09 and about 32.5 million shares on a fully diluted basis. Importantly, the ongoing Phase 3 clinical trial protocol received Fast Track designation from the FDA and is being conducted under a Special Protocol Assessment (SPA).
A key development for EXACT Sciences (NASDAQ:EXAS) is the replacement of a large collection bucket associated with the Company’s stool DNA screening test for colorectal cancer (CRC) with a much smaller (less than two ounces) system that will greatly enhance the commercial prospects and logistics associated with the development of the next-generation V3 test. The much smaller size of the collection system for the V3 test will make it much easier for doctors to store in their offices and simplify the shipping process for lab processing.
This adds to positive news announced during the 2Q09 conference that the Company’s pending Phase 3 FDA study is likely to be much smaller in scale (e.g. 3,000 subjects) and less costly versus the previous guidance of 8,000-10,000 subjects enrolled at 30-40 clinical sites that would have taken 12-18 months to complete. The objective of this study is to obtain broad claims and FDA marketing clearance for a non-invasive stool DNA based CRC screening test, including the detection of pre-cancers. The stock research section of BioMedReports.com includes my 2Q09 update report for EXAS, including an earnings model in the U.S. market, targeting a major unmet medical need for an estimated 90 million people over the age of 50.
Unilife Medical Solutions (UNIFF.PK) (UNI.AX) is in the process of obtaining a primary U.S. listing on the NASDAQ as part of its relocation to Central Pennsylvania where the Company began manufacturing the FDA-cleared Unitract 1mL Insulin Syringe in August 2009. Unilife boasts an impressive, experienced management team that delivers on its objectives – as evidenced by the Company’s Industrialization Program for the Unilife Ready-to-Fill Syringe that is one year ahead of schedule, targeting completion by the end of 2010.
Click here for my previous article coverage of Unilife at BioMedReports.com, beginning in late March when the stock was trading around the 25 cent range with little to no volume for the U.S. Pink Sheet listing (UNIFF.PK) which is quickly approaching $1/share as the Company nears a NASDAQ listing. In addition, the research section of BioMedReports.com includes a report by Griffin Securities with a US$3 price target and the Company’s most recent corporate presentation. Highlights from the report include the following:
1.) Unilife has a disruptive drug delivery technology with a sound strategy to enter the U.S. and European needle and syringe markets
2.) Unilife has a big pharma partner in Sanofi-Aventis (NYSE:SNY), which is investing $38 million into the Company through an industrialization agreement in addition to a strong relationship with the Commonwealth of Pennsylvania
3.) Starting next year, additional supply agreements in other therapeutic areas (outside of the SNY agreement) are anticipated
Disclosure: Long EXAS. See my full disclaimer at MikeHavRx.com at the bottom of any page.
The study involved treatment of 80 subjects with Stage III or Stage IV metastatic melanoma. The primary objective of the Phase 2 study is to investigate the effectiveness of intralesional (IL) PV-10 for locoregional treatment of metastatic melanoma. The study also includes assessment of response in untreated bystander lesions following intralesional injection of PV-10 into treated lesions.
Additional objectives of the trial are to determine the safety profile of PV-10 following intralesional injection, and assess the pharmacokinetic profile of PV-10 in the bloodstream following intralesional injection. The Phase 2 study is an interventional, open-label, multicenter, single group assignment safety/efficacy study. To accurately reflect anticipated clinical use, repeat dosing of lesions not exhibiting complete response was allowed at the investigator’s discretion several times following initial treatment. Subjects are followed for 52 weeks following initial treatment with PV-10. The estimated primary completion date for this trial is May 2010, with an estimated study completion date of July 2010.
On 9/21/09, Incyte Corp. (NASDAQ: INCY) ($7.97, +9%, above-average volume on 21-Sep) announced positive clinical trial results for a topical formulation of its lead janus kinase (JAK) inhibitor, INCB18424, in psoriasis. These results were obtained from a multi-center three-month Phase IIb trial comparing three once-daily doses of topical INCB18424 to vehicle in 200 patients with mild-to-moderate psoriasis. In the trial patients treated with INCB18424 had a statistically significant improvement over placebo in the reduction in total lesion score (erythema + scaling + thickness), which was the primary efficacy endpoint of the trial.
Statistical significance was also achieved for the secondary endpoints: the Physician Global Assessment score and the Psoriasis Area and Severity Index score. INCB18424 was well tolerated at all doses and no clinically significant effects were noted in hematology or other laboratory parameters. Incyte intends to present full results from this Phase IIb trial at an appropriate future scientific meeting.
On 9/21/09, results were presented in Europe by OncoMethylome Sciences (EBR: ONCOB.BR) ($6.60, +10%, above-average volume on 21-Sep) for a blood-based diagnostic test for colorectal cancer (CRC). The researchers collected blood before surgery from 193 patients known to have CRC, as well as from 688 controls undergoing colonoscopy for cancer screening. DNA was extracted from the blood plasma and tested for the presence of DNA methylation of specific genes. Based on studies conducted in colorectal tissues, methylated genes that were capable of discriminating accurately between cancerous and normal tissues were chosen, including two newly reported methylation genes, SYNE1 and FOXE1, in patients with CRC that occur infrequently in individuals who do not have the disease.
When testing a first set of 444 controls and 124 colorectal cancer patients, with plasma volumes ranging between 0.8—4.3 mL (as a reference point, 1 teaspoon = 5 mL), the sensitivity and specificity for the combination of SYNE1 and FOXE1 was 58% and 90% respectively. Testing this marker combination in a second, independent group of 242 controls and 69 cases, the sensitivity (proportion of positives correctly identified) and specificity (proportion of negatives correctly identified) were 56% and 91% respectively (77% and 91% in the samples with at least 3.3 ml of plasma).
The sensitivity for stage I and II CRC was 41% and 80%, respectively. The scientists are currently enrolling people into a prospective colorectal screening study in several German colonoscopy facilities and expect to complete enrollment of 7,000 people by the end of 2009 in conjunction with discussions to several partners about distribution rights.
The V3 stool DNA screening technology being developed by EXACT Sciences (NASDAQ:EXAS) outperforms blood-based tests, especially for earlier stage disease / pre-cancer detection, which is critical for improved treatment and survival outcomes. In August 2008, research was published in which a total of 25 sDNA samples from CRC patients were analyzed and a next generation stool DNA technology (V3) correctly identified 23 (92%) of the cancers. In the 16 of 25 cases where there were paired stool and plasma DNA samples, the sDNA technology detected mutated DNA in stool in 14 cases (88%) while only 8 (50%) corresponding plasma DNA samples had detectable levels of mutated DNA.
In addition, improvements to stool DNA screening technology to-date include ability to detect over 85% of CRCs and 50% of pre-cancers (higher than the 41% sensitivity for Phase I CRC reported yesterday by OncoMethylome) versus rates of about 50% and 20%, respectively, with potential to expand sDNA screening technology for other GI-related cancers such as gastric, pancreatic, etc. after commercializing the V3 test for CRC.
Another key development for EXAS discussed at the Rodman Healthcare conference is the replacement of a large collection bucket associated with the Company’s stool DNA screening test for CRC with a much smaller (less than two ounces) system that will greatly enhance the commercial prospects and logistics associated with the development of the next-generation V3 test. The much smaller size of the collection system for the V3 test will make it much easier for doctors to store in their offices and simplify the shipping process for lab processing.
This adds to positive news announced during the 2Q09 conference that the Company’s pending Phase 3 FDA study is likely to be much smaller in scale (e.g. 3,000 subjects) and less costly versus the previous guidance of 8,000-10,000 subjects enrolled at 30-40 clinical sites that would have taken 12-18 months to complete. The objective of this study is to obtain broad claims and FDA marketing clearance for a non-invasive stool DNA based CRC screening test, including the detection of pre-cancers. The stock research section of BioMedReports.com includes my 2Q09 update report for EXAS, including an earnings model in the U.S. market, targeting a major unmet medical need for an estimated 90 million people over the age of 50.
On 9/22/09, BSD Medical (NASDAQ: BSDM) ($3.85, +105%, above-average volume on 22-Sep) announced that clinical trial results were the subject of a news briefing at Europe’s largest cancer congress (ECCO15 – ESMO34) which utilized the BSD-2000 Hyperthermia System, demonstrating that patients with high risk soft-tissue sarcomas were 30% more likely to be alive and cancer free almost three years after starting treatment if targeted heat therapy (hyperthermia) was added to their chemotherapy treatment.
The Phase 3 study involved 341 patients who were treated at medical centers in Europe and in the U.S. All patients had locally advanced soft tissue sarcomas and were at high risk of recurrence and spread. All patients were given chemotherapy before and after surgery and radiotherapy. Half of the patients were randomly given hyperthermia along with chemotherapy.
“The patients receiving the targeted heat therapy fared better on all outcome measurements,” Prof. Issels said. “Almost three years after starting treatment, they were 42% less likely to experience a recurrence of their cancer at the same site or to die than those who were getting chemotherapy alone, surviving an estimated 120 months before local progression of their disease, compared with an estimated 75 months. Similarly, the average length of time that patients remained disease free was 32 months in the group that got both treatments, compared with 18 months in the group that got chemotherapy alone – an improvement of 30%.”
On 5/18/09, BSDM announced that the FDA has granted Humanitarian Use Device (HUD) designation for the company’s BSD-2000 Hyperthermia System for use in conjunction with radiation therapy for the treatment of cervical carcinoma patients who are ineligible for chemotherapy. This is the first of the two steps required to obtain Humanitarian Device Exemption (HDE) marketing approval, which requires BSD Medical to demonstrate the device’s safety and probable benefit in treating a disease or condition that affects fewer than 4,000 individuals in the U.S. per year.
Now that FDA has granted the HUD for the BSD-2000, BSD can file an HDE submission with the FDA. FDA has 75 days from the date of receipt of the HDE submission to grant or deny an HDE application. BSDM believes that data previously submitted to FDA and reviewed by the Agency as part of the Company’s pending medical device Pre-market Approval (PMA) submission can be used to support the HDE approval, and that this previous review may expedite marketing approval for the BSD-2000.
Due to the lengthy nature of the PMA review process, the length of time that the submission has been under review by the FDA, and the Company’s strong desire to bring the BSD-2000 to market as quickly as possible, the FDA recommended that BSDM pursue a HDE marketing approval to authorize the commercial sale of the BSD-2000 in the U.S. On 1/7/08, BSDM received a letter from the FDA providing guidance as to amendments needed to make the PMA approvable and the Company responded to this letter on 7/17/08.
In a letter to shareholders on 7/29/09, BSDM stated that, “We expect to hear from the FDA very soon regarding our HDE application.”
Disclosure: Long EXAS.
See my full disclaimer at MikeHavRx.com (bottom of any page).
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