Allos | Get it When You Can...

Many a seasoned and sophisticated biopharma executive have described to me the reality of when an entity does not need to raise capital it should because at some point it will be needed, and by not needing it, the situation may, just may…lend itself to perhaps lowering the cost of capital due in part to the leverage of not exactly needing it at the time of the raise (Wow, that was a mouthful). Now that Allos Therapeutics (NASDAQ: ALTH) has hung out their ‘open for business’ sign with the recent approval of Folotyn™ for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma is additional capital required? Well building a commercial enterprise may take upwards of $10 to $20M, there are now scaled manufacturing needs and let us also consider the broad ongoing clinical pursuits for follow-on indications of Folotyn™. No doubt, all capital intensive pursuits.

A quick scan of the most recent balance sheet for Allos indicates cash and cash equivalents plus short term investments totaling approximately $105M, certainly that has evaporated throughout the second quarter at a burn rate of perhaps $14.1M (cash from operations plus cap ex), leaving a guesstimated cash position at around $80 - $90M today? Not exactly an uncomfortable place to be sitting. So what is one to do sitting in this seemingly well capitalized position? Correct! Go out and raise more money! And that is exactly what the plan is.

Allos has announced the price of a new public offering of 14,000,000 shrs of common stock set at $7.10 yielding a planned gross proceeds of $99.4M, expected to close on 13 October. Allos has also granted the underwriters a 30-day option to purchase up to an aggregate of 2,100,000 additional shares of common stock to cover over-allotments, if any. The deals’ underwriters include J.P. Morgan Securities, Citigroup Global Markets, Leerink Swann, JMP Securities, Needham & Company, and RBC Capital Markets.

Get it when you can…

Allos THx | Significant Milestone Achieved!!!

Now, some 48-hours later, it may be considered old news that Allos Therapeutics (NASDAQ: ALTH) received from FDA accelerated approval for Folotyn™ (pralatrexate) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Folotyn™ is the first and only drug approved by FDA for PTCL and represents a new treatment option for patients with relapsed or refractory PTCL. Allos anticipates entering the market with Folotyn™ in the US in October. The sound of champagne corks popping can be heard echoing up and down the Front Range as the Colorado life science ecosystem celebrates this significant and important milestone and simultaneously breaths a collective sigh of relief.

Let’s then take a bit of a closer look at Allos, their approved product, market and pipeline, shall we? (As always…if there is any erroneous data or statements identified and requiring correction please leave a comment below or email arubenstein@rnaventures.com and we will update with or without (your choice) attribution).

Hematological malignancies account for approximately 15% of all cancers and are categorized into four groups, 1. Multiple Myeloma, 2. Myelodysplastic Syndromes, 3. Leukemia – which includes acute myeloid, acute lymphoblastic, chronic myeloid, and chronic lymphocytic leukemia, and 4. Lymphoma – which is divided into Hodgkin’s and non-Hodgkin lymphoma. NHL is further grouped into:

• Cutaneous T-cell lymphoma
• Follicular lymphoma
• Mantle cell lymphoma
• Diffuse large B-cell lymphoma, and
• Peripheral T-cell lymphoma
  

According to the American Cancer Society, non-Hodgkin lymphoma incidence has grown 3.8% from 2005 to 2009. The US PTCL market is growing at an estimated incidence rate of 5% due, in part, to increased PTCL awareness; the addressable market is approximately 80-90% of estimated first-line patients treated (according to Allos), or more specifically of ~6,800 patients forecasted in 2013, ~6,200 are treatable. It has been reported that single agent treatments prescribed off label for PTCL average approximately $76,000 per patient per therapeutic and therefore one may calc the total addressable market at ~$516M to $471M per year – NOTE: this is not a market forecast for Folotyn™.

Allos maintains exclusive worldwide commercial rights to Folotyn™ for all indications and their exists the potential for co-promotion or out-licensing to reach EX-US markets. The composition of matter patent protection is in place till 2017 in the US and EU with the potential for an additional 5-year extension under Hatch-Waxman. Additional potential hematological malignancy indications for Folotyn™ that are under clinical investigation include B-cell non-Hodgkin’s lymphoma, non-Hodgkin’s lymphoma and cutaneous T-cell lymphoma, and in solid tumor indications for bladder cancer and non-small cell lung cancer.

Folotyn™, a next generation chemotherapy, is a rationally designed, for improved cancer cell uptake and retention, anti-folate. The mechanism of action of Folotyn™ is a folate analog that inhibits folate metabolism by binding to and inhibiting the enzyme DHFR. Folotyn™ has high affinity for the RFC-1 protein and is an efficient substrate for polyglutamation by the enzyme FPGS. Polyglutamated Folotyn™ has a prolonged intracellular half-life, which allows for prolonged action in malignant cells. The relative increase in cellular uptake by RFC-1 and differences in polyglutamate formation may account for the enhanced activity of Folotyn™.


Some additional players in the hematological malignancy market include Biogen Idec (NASDAQ: BIIB) who markets with Roche (VTX: ROG.VX) Rituxan® for non-Hodgkin’s lymphoma; Novartis (NYSE: NVS) who markets Gleevec® for chronic myeloid leukemia, and; Wyeth (Pfizer) (NYSE: WYE) who markets Mylotarq® for acute myeloid leukemia.

It will be fascinating to observe Allos evolve from a development-stage company to a commercial-stage entity. Needless to say this is an incredible achievement – bringing a new treatment option to market for patients with relapsed or refractory PTCL.

FDA Allos pic courtesy of http://topnews.us

Allos THx | He Said, She Said Monday…

FDA will seek input from the Oncologic Drugs Advisory Committee on Wednesday 2 September re: review of Allos Therapeutics’ (NASDAQ: ALTH) New Drug Application for pralatrexate (Folotyn); for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. It appears as though reviewers have questioned some findings reported by the Company on the effectiveness of its proposed drug.

FDA issues with the Allos application appear to be:

1. The clinical significance of tumor response and duration of response, and
2. Whether the benefit:risk ratio is favorable
   

Allos reported, in-part, that 29 patients, or 27%, responded to treatment with Folotyn however, agency reviewers are challenging the verification on one or more of these responses and one or more of their associated durations.

Take a look at the FDA Briefing Document [HERE].

Allos: Positive Phase I Interim Data for PDX

Allos Therapeutics (NASDAQ: ALTH) announced positive interim data from their Phase I dose optimization study of PDX (pralatrexate) with vitamin B12 and folic acid supplementation in patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL). The data demonstrated activity in a range of doses, and will continue with the objective of determining the optimal dose and schedule for patients with CTCL.

Data were presented on 17 patients, including 14 evaluable patients who completed at least one cycle of treatment with PDX at doses ranging from 15-30 mg/m2 as part of a weekly schedule for two or three weeks followed by one week of rest. Patients received a median of three prior systemic therapies. Investigator-assessed responses were observed in 7 of 14 evaluable patients, including two complete responses and five partial responses. Responses were observed in all four treatment cohorts. The most common adverse event was mucositis.

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Allos: Encouraging Data = Next Round of Financing

On the heels of Allos Therapeutics (NASDAQ: ALTH) reporting of positive interim data for their pivotal Phase II PDX (pralatrexate) trial, where a 29% of 65 T-cell lymphoma patients had either a complete or partial response, have now unveiled their follow-on financing strategy for ongoing clinical requirements in addition to preclinical R&D of pipeline candidates, manufacture of clinical trial material, pre-commercial scale-up activities for PDX, working capital and general corporate purpose needs. That is the planned sale of 9.00M shares of newly issued common stock with up to an additional 1.35M shares available to cover over allotments. Banc of America and Citigroup are acting as co-lead underwriters on the financing which is expected to be declared effective early in June. Recall Allos last issued 9M shrs about a year and a half ago raising just north of $50M; if this new financing is priced similarly at $6/share one could expect the deal to bring in approximately $62M less expenses.

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Allos: Completes Phase II PDX Study Enrollment

Allos Therapeutics (NASDAQ: ALTH) has completed patient enrollment a quarter ahead of schedule for their Phase II trial of PDX (pralatrexate) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).The pivotal Phase II trial is an international, multi-center, open-label, single-arm study that enrolled patients with relapsed or refractory PTCL who progressed after at least one prior treatment. Patients receive 30 mg/m2 of PDX once every week for six weeks followed by one week of rest per cycle of treatment, the treatment regimen also includes vitamin B12 and folic acid supplementation. The primary endpoint of the study is objective response rate (complete and partial response), secondary endpoints include duration of response, progression-free survival and overall survival.

The FDA granted orphan drug designation and fast track designation to PDX for the treatment of PTCL patients, and likewise the Committee for Orphan Medicinal Products of the European Medicines Agency granted orphan medicinal product designation to PDX.

Peripheral T-cell lymphomas, or PTCLs, are a biologically diverse group of blood cancers that account for approximately 10% to 15% of all cases of non-Hodgkin's lymphoma in the US. There are currently no pharmaceutical agents approved for use in the treatment of either first-line or relapsed or refractory PTCL. Patients are often treated with multi-agent chemotherapy regimens however, a significant number of these patients relapse or become refractory after treatment with first-line therapy. The average five-year survival for those patients was approximately 25%.

PDX is a novel, small molecule chemotherapeutic agent that inhibits dihydrofolate reductase, or DHFR, a folic acid (folate)-dependent enzyme involved in the building of nucleic acid, or DNA, and other processes. PDX was rationally designed for efficient transport into tumor cells via the reduced folate carrier, or RFC-1, and effective intracellular drug retention. Allos believes these biochemical features, together with preclinical and clinical data in a variety of tumors, suggest that PDX may have a favorable safety and efficacy profile relative to methotrexate and other related DHFR inhibitors and, has the potential to be delivered as a single agent or in combination therapy regimens.

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Allos Sets the Stage for 2008

At the recent year-end call Allos Therapeutics (NASDAQ: ALTH) reported financial and developmental 2007 highlights. As-of 31 December the company had a cash and cash equivalent position of $57.8M on hand, the coffers were achieved primarily via a 1Q07 9M common share offering that raised just north of $50M. With a quarterly burn of approximately $11M management believes they are well positioned through 1Q09.

For PDX (pralatrexate) an interim safety analysis for the PROPEL study was completed that supported the continuation of the trial, and received orphan medicinal product designation for the treatment of patients with peripheral T-cell lymphoma from the Commission of the European Communities. This designation complements the orphan drug and fast track designations previously granted for the treatment of patients with T-cell lymphoma by the FDA. Additional solid tumor and lymphoma trials have been enrolling including a Phase IIb study of PDX versus Genentech’s (NYSE: DNA) and OSI Pharma's (NASDAQ: OSIP) Tarceva® in patients with Stage IIIB/IV non-small cell lung cancer who are or have been cigarette smokers, who have failed treatment with at least one prior platinum-based chemotherapy regimen. As well as ongoing enrollment in a Phase I/IIa study of PDX and gemcitabine with vitamin B12 and folic acid supplementation in patients with relapsed or refractory non-Hodgkin's lymphoma. And a Phase I study of PDX with vitamin B12 and folic acid supplementation in patients with relapsed orrefractory cutaneous T-cell lymphoma. And, for the RH1 asset, a Phase I study of patients with advanced solid tumors or non-Hodgkin's lymphoma was initiated.

Setting the Stage for 2008:

The Company currently has six ongoing clinical trials involving PDX, including the PROPEL trial, evaluating the compound's potential clinical utility in hematologic malignancies and solid tumor indications. Looking at 2008 Allos intends to complete enrollment in PROPEL by 2Q08 and plans to report top-line results of the trial by 4Q08. If the results are positive management anticipates filing for regulatory approval to market PDX for the treatment of peripheral T-cell lymphoma. Management may initiate an additional Phase II single-agent study in another solid tumor indication in 1H08 and an additional Phase I combination study in solid tumor indications by year end.

Architecting for success includes execution of product launch planning. Allos retains exclusive worldwide rights to PDX for all indications and intends to commercialize PDX, if approved for marketing, by building an oncology focused US sales and marketing organization. Hoping for nothing but the best for Allos in 2008, may be a seminal year in the history of the company!

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Colorado Public Company News:

By my calculations there are ten publicly traded CO-based life science companies. I will begin a regular update of this group. Another group of public companies are operating in or have other significant interests or relationships with entities in Colorado. This group includes Amgen (NASDAQ: AMGN), Gilead (NASDAQ: GILD), Merck (NYSE: MRK), Roche (VTX: ROG.VX) and Agilent (NYSE: A). I plan to do equivalent updates of this Colorado-Related Public Company group. Naturally if I am overlooking any companies that should be included in either category please bring them to my attention (via email).

Accelr8 (AMEX: AXK) ’06 REVENUE: ~ $213K APPROVED PRODUCT(S): None FOCUS: deliver bacterial identification and specific antibiotic susceptibility testing within 8 hours of specimen receipt. PIPELINE: development stage for the BACcel™-1.0 and the BACcelr8r™, based on its innovative surface coatings, assay processing, and detection technologies. Accelr8 also licenses certain of its proprietary technology for use in applications outside of its own products. NEWS: Announced accumulation of large data sets from prototype instruments and validating assays, next focus to ramp engineering to develop marketable product, Presented MRSA data at ASM meeting

Allos Therapeutics (NASDAQ: ALTH) '06 REVENUE: ~ ($32MM) APPROVED PRODUCT(S): None FOCUS: on the development of small molecule therapeutics for cancer PIPELINE: Pralatrexate (PDX) lead 2 Phase II for peripheral T-cell lymphoma and non-hodgkin’s lymphoma 3 Phase I for non-hodkin’s lymphoma (PDX plus gemcitabine), non-small cell lung cancer and T-cell lymphoma (PDX plu folic acid) NEWS: Presented at Bear Sterns conference yesterday, replay is (here), initiated enrollment for Phase I PDX plus folic acid study added to the Russel1 3000 broad market index.

Array BioPharma (NASDAQ: ARRY) – ’06 REVENUE: ~ $45MM APPROVED PRODUCT(S): None FOCUS: Cancer and inflammatory disease small molecule drugs. PIPELINE: 1 Phase II candidate ARRY886 MEK target, 6 Phase I candidates ErbB-2/EGFR, p38, KSP, MEK targets, 3 Pre-clinical candidates. NEWS: CEO Rob Conway presented at the TWP Healthcare conference last week. The webcast has not been posted yet, expect to find it (here), ARRY380 advances to Phase I trial

Aspen BioPharma (NASDAQ: APPY) ’06 REVENUE: ~ $1.2MM APPROVED PRODUCT(S): Manufactures and markets approximately 30 purified protein products primarily for use as controls by diagnostic test kit manufacturers and research facilities, to determine whether diagnostic test kits are functioning properly. FOCUS: Development of novel animal reproduction products for large worldwide markets. PIPELINE: Developing diagnostic products, such as AppyScore ELISA test and AppyScreen, for. It also provides three bovine reproduction products, SurBred, a blood test designed to determine pregnancy status in dairy cattle; StayBred, a luteinizing hormone analog for inducing ovulation in cows; and BoviPure FSH, a follicle stimulating hormone analog for ovulation and embryo transfer in dairy and beef cows. The company is developing two equine reproduction products, EquiPure LH, a luteinizing hormone analog for inducing ovulation in estrous mares; and EquiPure FSH, a follicle stimulating hormone analog for ovulation and embryo transfer in horses. NEWS: Presented at Roth Capital Partners conference, webcast available (here). Shares recently moved from trading on the OTC bulletin board under APNB.OB to the NASDAQ capital mrkts xchange under APPY.

Ceragenix Pharma (OTCBB: CGXP.OB) ’06 REVENUE: ~ ($4.7MM) APPROVED PRODUCT(S): EpiCeram® for treatment of atopic dermatitis (eczema) FOCUS: a biopharmaceutical company engaged in the discovery, development, and commercialization of a portfolio of small molecule cationic steroid antibiotic products in the fields of infectious disease and dermatology PIPELINE: preclinical candidates for neonatal barrier repair, cvc infections and burn dressing. Products are all based upon skin barrier repair and the ceragenin technologies NEWS: Recent recipient of the Frost & Sullivan's 2007 North American Technology Innovation Award for the field of Anti-Infective Coatings. Have not been able to consummate licensing deal for EpiCeram® by the forecasted dates previously released, commercialization is targeted for 2008. In vitro data indicate that CSA-13 may be effective to treat multi-drug resistant Pseudomonas aeuroginosa.

Encision (AMEX: ECI) ’06 REVENUE: ~ $11MM APPROVED PRODUCT(S): Sells a range of articulating instruments, such as scissors, graspers, and dissectors; fixed-tip electrodes; and suction-irrigation electrodes. In addition, Encision markets the Active Electrode Monitoring System monitor product line that is used in conjunction with the AEM Instruments. FOCUS: A medical device company offering a line of AEM Surgical Instruments, which prevents stray electrosurgical burns from insulation failure and capacitive coupling. PIPELINE: ? NEWS: Received warning letter from AMEX that ECI did not satisfy rule for continued listing. Reported a 3% decrease in quarter-over-quarter in net sales, ordering patterns of reorders for re-usable equipment was cited as a cause for the decrease. Will begin to manufacture its own disposable scissor inserts.

Heska (NASDAQ: HSKA) ’06 REVENUE: ~ $75MM APPROVED PRODUCT(S): Vet ABC-Diff Hematology System, ALLERCEPT® Allergy Testing and Treatment, CBC-Diff™ Veterinary System, E.R.D.-HealthScreen® Urine Tests, F.A. Granules, HemaTrue™ Veterinary System, i-STAT® Clinical Analyzers, Solo Step® Heartworm Tests, SPOTCHEM™ EZ Chemistry System, ThyroMed™ Chewable Tablets and Feline UltraNasal® Vaccines FOCUS: The company operates in two segments, Core Companion Animal Health, and Other Vaccines Pharmaceuticals and Products. The Core Companion Animal Health segment includes diagnostic and other instruments and supplies, as well as single use diagnostic and other tests, vaccines, and pharmaceuticals primarily for canine and feline use. PIPELINE: TBD NEWS: 3Q07 earnings call set for 7 November, call in info (here)

Pharmion (NASDAQ: PHRM) – ’06 REVENUE: ~ $239MM APPROVED PRODUCT(S): Vidaza® for myelodysplastic syndromes, Thalidomide® for multiple myeloma, erythema nodsum leprosum, Innohep® for deep vein thrombosis Refludan® heparin-induced thrombocytopenia FOCUS: Hematology and oncology PIPELINE: 4 Phase III candidates MDS, 1st and 2nd line MM, hormone refractory prostate caner, 5 Phase II candidates acute myelogenous, small cell lung cancer hematological malignancies, 4 Phase I candidates NEWS: Presentation from yesterday’s Bear Stearns conference will be posted (here), oral Azacitidine was granted fast-track status for myelosdysplastic syndromes, granted US Orphan Drug status for MGCD0103 for the treatment of hodgkin’s lymphoma

Replidyne (NASDAQ: RDYN) ’06 REVENUE: ~ $16MM APPROVED PRODUCT(S): None FOCUS: focused on discovering, developing, in-licensing, and commercializing anti-infective products. PIPELINE: 3 Phase III for bronchitis, sinusitis/pneumonia and acute otitis media, 2 Phase I for skin infections (impetigo and MRSA) and wound infections NEWS: Keep your eyes peeled for announcement of a new development partner for Faropenem.

Tapestry Pharma (NASDAQCM: TPPH) ’06 REVENUE: ~($17MM) APPROVED PRODUCT(S): None FOCUS: oncology, third-generation taxane prostate for pancreas and glioblastoma mutliforme PIPELINE: 1 Phase II candidate TPI287 for hormone refractory prostate cancer NEWS: Recently reported 2Q07 financial results, recently withdrew S-1 filing for proposed $40MM common stock offering based upon encouraging data presented at ASCO and is pursuing other financing opportunities.

Action At Allos

Lot’s of action transpiring at Allos Therapeutics (NASDAQ: ALTH) since Paul Berns has taken over the reigns. We should expect a $50.5M financing to close tomorrow courtesy of Merrill, where 9M shares of common are being floated at $6 less underwriting fees and expenses, much of which to be gobbled up by Baker Brothers Life Sciences Capital. The lion share of the use-of-proceeds will be allocated to advancing pralatrexate (PDX) clinical work. Recently an independent data monitor completed an interim safety analysis and indicated PDX should continue in its pivotal Phase II trail in patients with relapsed or refractory peripheral T-cell lymphoma. A second interim safety analysis should be expected following 35 enrollees who have completed at least one cycle of PDX treatment. Finally, William Ringo was appointed to the Allos board. Mr. Ringo, most recently served as President and CEO of Abgenix and guided the $2.7B acquisition by Amgen.

Allos + NASDAQ = Great News!

Allos Therapeutics, Inc. (NASDAQ: ALTH) having met all minimum requirements was added to the NASDAQ Biotechnology Index. Being added to an index typically yields an uptick in share price and corresponding market cap as all funds, ETF’s, separate accounts etc. that mirror an index must purchase the newly added position, in this particular case the iShares NASDAQ Biotechnology Index Fund (AMEX: IBB).

Taking a look at average daily volume of ALTH shares traded is ~275K however, today one may observe the buy spike of ~540K.

If you want to see a pretty one year chart take a look at this:

Allos Therapeutics: Promising Data

Allos Therapeutics, Inc. (NASDAQ: ALTH) announced safety results from its Phase I/II trial of Pralatrexate (PDX) in patients with non-Hodgkin's lymphoma and Hodgkin's disease, and from its Phase II study of efaproxyn in patients with unresectable non-small cell lung cancer receiving sequential chemoradiotherapy (S-CRT).

Results of the PDX sudy indicate a higher incidence of stomatitis was observed in patients with elevations in pre-treatment homocysteine (Hcy) and methylmalonic acid (MMA). Little to no increase in stomatitis occurred in patients with Hcy and MMA less than 10 mM and 200 nM respectively. Patients with elevated Hcy and MMA who developed stomatitis with PDX did not develop advanced grade stomatitis after normalization of their Hcy and MMA with folic acid and vitamin B12 supplementation. Subsequent to this finding, all enrolled patients have received pre-treatment with vitamin B12 and folic acid, and normalization of Hcy and MMA levels has mitigated the incidence of stomatitis.

In July 2006, the FDA awarded orphan drug designation to PDX for the treatment of patients with T-cell lymphoma. PDX is a novel, small molecule chemotherapeutic agent that inhibits dihdrofolate reductase (DHRF), a folic acid dependent enzyme involved in the building of DNA and other processes. PDX was rationally designed for improved transport into tumor cells via the reduced folate carrier (RFC-1), and greater intracellular drug retention. These biochemical features, together with preclinical data in a variety of tumors, suggest that PDX has an enhanced potency and improved toxicity profile relative to methotrexate and other related DHFR inhibitors.

The efaproxyn study compared the safety and efficacy of efyaproxyn when administered with S-CRT in patients with unresectable NSCLC compared to data from a Phase III, Radiation Therapy Oncology Group (RTOG) study. Results of a 5-year survival analysis indicated that patients in the efaproxyn study exhibited superior survival to patients with similar characteristics in the RTOG study. Median survival of patients treated in the efaproxyn study was 20.6 months as compared to a median survival of 13.3 months for matched cases in the S-CRT arm of the RTOG study and 16.9 months in the concurrent chemoradiotherapy (C-CRT) arm of the RTOG study. The Kaplan-Meier estimates of 5-year survival rates for matched cases were 19% in the efaproxyn study and 10% in both the S-CRT and C-CRT arms of the RTOG study.

Efaproxyn is the first synthetic small molecule designed to sensitize hypoxic or oxygen-deprived areas of tumors during radiation therapy by facilitating the release of oxygen from hemoglobin, and increasing the level of oxygen in tumors. The presence of oxygen in tumors is an essential element for the effectiveness of radiation therapy. By increasing tumor oxygenation, Allos believes that efaproxyn has the potential to enhance the efficacy of standard radiation therapy.

Allos Therapeutics Receives Orphan Status

The FDA has granted Allos Therapeutics (NASDAQ: ALTH) next-generation chemotherapy drug pralatrexate, or PDX, for the treatment of T-cell lymphoma, with an orphan drug designation.

An orphan drug designation is assigned to a drug that targets the treatment of a disease with less than 200,000 sufferers in the U.S. The status provides seven years of marketing exclusivity for the treatment should it gain approval, along with tax breaks and possible development funding.

Allos Therapeutics Names New CEO

Allos Therapeutics, Inc. announced today the appointment of Paul L. Berns as the Company's President, Chief Executive Officer and a member of the Board of Directors, effective immediately.

Mr. Berns brings close to 15 years of pharmaceutical industry experience to Allos. While leading Bone Care International, Inc. from June 2002 until its acquisition by Genzyme, Corp. in July 2005, revenues increased nearly 14-fold, the company became profitable and market capitalization increased from approximately $40 million to a sale value of $719 million. Prior to joining Bone Care International, Inc., Mr. Berns held senior management positions at Abbott Laboratories, BASF Pharmaceuticals, and Bristol-Myers Squibb Company.

Allos Announces Survival Benefits of Efaproxyn™ in Phase III Study

Allos Therapeutics, Inc. (Nasdaq: ALTH) announced the results from its Phase III study of Efaproxyn™ in patients with brain metastases. Results of the study, which were reported in the Journal of Clinical Oncology, suggest that the addition of Efaproxyn™ to whole brain radiation therapy may improve survival and response rates in patients with brain metastases, particularly those from breast cancer.

To further confirm the survival benefit observed in the breast cancer subgroup in the trial, in February 2004, the Company initiated a Phase III, randomized, open-label, multi-center trial designed to compare the effect of whole brain radiation therapy with supplemental oxygen with or without Efaproxyn™ in women with brain metastases from breast cancer. Allos currently expects to complete patient enrollment in the trial during the second half of 2006 and report preliminary results approximately six months thereafter.

Efaproxyn™ is the first synthetic small molecule designed to sensitize hypoxic, or oxygen-deprived, areas of tumors during radiation therapy by facilitating the release of oxygen from hemoglobin, the oxygen-carrying protein contained within red blood cells, and increasing the level of oxygen in tumors. The presence of oxygen in tumors is an essential element for the effectiveness of radiation therapy. By increasing tumor oxygenation, Allos believes that Efaproxyn™ has the potential to enhance the efficacy of standard radiation therapy.